The Effectiveness of a Body Positioning Device for Controlling Patient Movement and Additional Sedative Use during ERCP: A Retrospective Analysis

The Effectiveness of a Body Positioning Device for Controlling Patient Movement and Additional Sedative Use during ERCP: A Retrospective Analysis | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article The Effectiveness of a Body Positioning Device for Controlling Patient Movement and Additional Sedative Use during ERCP: A Retrospective Analysis Haruka Masuda, Tsutomu Nishida, Kengo Matsumoto, Dai Nakamatsu, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5423780/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background : Endoscopic retrograde cholangiopancreatography (ERCP) is a precise procedure requiring appropriate body movement control for procedural safety and efficiency. Sedatives are commonly used but pose risks, especially for elderly patients. This study evaluated the effectiveness of the Medo V-Fix device for controlling patient movement during ERCP. Methods : Of 1558 ERCP procedures performed between January 2021 and March 2024, 1,723 were analyzed after excluding cases with missing data. Patients were divided into two groups, the device group (n=697) and the nondevice group (n=831). The two groups were compared in terms of body movement control, additional sedative administration, and procedure discontinuation. Results : The baseline characteristics were similar between the groups. Body movement control was better with the device (good, 65.7%; poor, 24.0%; and very poor, 10.3%) than without it (good, 48.1%; poor, 30.7%; and very poor, 21.2%) (P<0.0001). The device reduced the need for manual assistance and additional doses of sedatives. Fewer patients in the device group required an additional dose of thiopental (9.5% vs. 15.6%, P=0.0003), and the dose was lower (4.5 mg vs. 6 mg, P=0.0015). There were no procedure discontinuations in the device group and 5 discontinuations in the nondevice group. Multivariate analysis revealed that device use and emergency procedures indicated good movement control. Propensity matching confirmed the association between devise use and better control (good: 64.9% vs. 49.1%, poor: 30.7% vs. 24.7% vs. 31.8%, and very poor: 10.4% vs. 19.1%, P<0.0001). Conclusions : The Medo V-Fix device significantly improved body movement control and reduced the need for both additional doses of sedatives and manual intervention, suggesting its potential for improving procedural safety and efficiency. Gastroenterology & Hepatology Figures Figure 1 Figure 2 Introduction Endoscopic retrograde cholangiopancreatography (ERCP) is a complex and technically demanding procedure that requires precise patient safety measures and procedural accuracy [ 1 ]. Uncontrolled patient movement during ERCP significantly increases the risk of complications and decreases the safety and efficiency of the procedure. To mitigate this risk, sedatives are typically administered to stabilize patients [ 2 , 3 ]. However, in elderly patients, the use of sedatives increase the risk of sedation-related complications (SRCs) [ 4 ]. Furthermore, according to most guidelines, an anesthesiologist is recommended to oversee procedures involving patients with multiple medical comorbidities and those considered to have airways that are difficult to manage [ 3 ]. This additional requirement may limit the use of alternative methods for effectively controlling patient movement. Given these challenges, physical restraints are promising alternatives for controlling patient movement during ERCP. Restraints can restrict patient movement, thereby enhancing the safety and precision of the procedure. Despite the risk of complications, the benefits outweigh the risks, and patients should also receive education and provide consent prior to undergoing the procedure. Studies suggest that physical restraints may reduce the need for sedatives and shorten the recovery time [ 5 ]​​, which is particularly beneficial for elderly patients. Medo V-Fix® (Century Medical Inc., Tokyo, Japan) is a body positioning device that was designed to improve patient stability during endoscopic procedures and introduced in August 2020. This user-friendly device is similar to other devices, such as the EZ-FIX® [ 5 ]​. This study retrospectively evaluated the effectiveness of the Medo V-Fix® device during ERCP, focusing on its impact on body movement control, patient safety, and need for sedatives. Methods Patients This single-center retrospective observational study was conducted using data from ERCP procedures consecutively performed at Toyonaka Municipal Hospital between January 2021 and March 2024. Among the 1,723 ERCP procedures reviewed, 195 cases were excluded because of incomplete data, resulting in 1528 cases for the final analysis. The study population was divided into two groups: the device group (n = 697) and the nondevice group (n = 831). Owing to the limited availability of the device, some procedures were conducted without it, resulting in a mixed sample. Ethics The study protocol adhered to the principles of the Declaration of Helsinki and was approved by the Ethics Committee of Toyonaka Municipal Hospital (2024-05-02). As this was a retrospective study using previously collected personal data, the need for informed consent was waived through the opt-out method on our hospital's website. Body Positioning Device The Medo V-Fix® device (Century Medical Inc., Tokyo, Japan) is a body positioning device that was introduced in November 2022 to increase patient stability during ERCP. This device involves the use of a mattress filled with beads that conform to the patient's body shape, distributing body pressure. By pressing a switch on a dedicated compressor, air is released from the mattress, causing it to harden through moderate decompression, thus maintaining the patient's body position. The compressor stops automatically with moderate decompression during this process, so the patient does not experience excessive pressure. If necessary, the mattress can be reinflated during the procedure, and the compressor will automatically reactivate, maintaining the desired level of immobilization. After the procedure, turning off and disconnecting the compressor quickly allows the mattress to return to its softened state. In some cases, the patient is temporarily positioned on their side for scope insertion, so the device can be used after the endoscope reached the papilla of Vater. In this study, the patient's consent to use the fixation device was obtained in writing before the examination, and the procedure was performed. ERCP Procedure ERCP was performed by trainees under the supervision of experts or experienced endoscopists at Toyonaka Municipal Hospital, a JGES-certified teaching hospital. Cannulation was performed using a wire loading method with a side-viewing duodenoscope (TJF-Q290V; Olympus Optical Co., Tokyo, Japan; ED-580T; Fujifilm, Tokyo, Japan). Diclofenac was administered rectally to prevent post-ERCP pancreatitis, and the dosage was adjusted according to body weight (25 mg or 50 mg), provided that there were no contraindications. Sedation and Analgesia Sedation was achieved with midazolam and pethidine hydrochloride. The initial dose of midazolam ranged from 2 mg to 3 mg, adjusted for patient weight and age. The initial dose of pethidine ranged from 7 mg to 10.5 mg, and an additional dose was provided as needed. Thiopental was used when midazolam or pethidine was insufficient for adequate sedation. Monitoring During ERCP During ERCP, patients were monitored by at least one nurse, the endoscopist and an assistant. If significant patient movement compromised monitoring, an additional nurse was brought in, or the procedure was discontinued. During the examination, the nurse monitored the patient's general condition, breathing, blood pressure, heart rate and saturation of percutaneous oxygen (SpO₂), recorded the patient’s progress and any SRCs in the nursing records. Body Motion Evaluation Body movement control was categorized into three grades: Good: Patient movement was effectively controlled with the scheduled dose of sedatives. Poor: Patient movement was controlled with higher-than- scheduled doses of sedatives. Very Poor: Patient movement was controlled with the assistance of additional personnel despite additional doses of sedatives. Outcomes The primary outcome was the grade of body movement control during ERCP. The secondary outcomes included the total dose of sedatives administered, the rate of procedure discontinuation due to inadequate movement control and the incidence of SRCs, such as hypoxia, hypotension and bradycardia. As data regarding SRCs were obtained retrospectively from nursing records, it is difficult to ascertain whether their documentation was objective or accurate. However, hypoxemia was diagnosed on the basis of decreases in SpO₂ from the start of treatment and the need for oxygen administration. Hypotension was diagnosed on the basis of a drop in blood pressure below 90 mmHg from baseline or the need for intravenous fluid administration. Bradycardia was diagnosed on the basis of a heart rate less than 50 beats per minute. Additional outcomes included procedure duration and radiation exposure metrics such as fluoroscopy time and the air kerma dose‒area product. Statistical Analysis Continuous variables are expressed as medians and interquartile ranges (IQRs), and categorical variables are presented as counts and percentages. Sample size calculations were not performed because of the retrospective nature of the study and the lack of prior evidence on which to base them. The Wilcoxon test was used to compare continuous variables, and categorical variables were compared using the χ² test or Fisher’s exact test, as appropriate. Trends in body movement control (good/poor/very poor) were assessed using the Cochran‒Armitage trend test. Bonferroni correction was applied to adjust for multiple comparisons, and a P value < 0.0167 was indicative of statistical significance. Logistic regression analysis was conducted to identify predictive factors of good body movement control, with seven variables evaluated: sex, age 75 years or older, BMI of 25 or higher, device use, emergency setting, first papilla, benign disease or malignancies, and postoperative stomach status. Propensity scores for good body movement control were calculated using these significant factors in a multiple logistic analysis, and a 1:1 matched study group was created with a caliper width of 0.05 to minimize selection bias. The device and nondevice groups were compared. A p value < 0.05 indicated statistical significance. Analyses were performed using JMP software (version 17.0.0, SAS Institute, Cary, NC, USA). Results Patient characteristics and basic ERCP-related parameters The baseline characteristics of the patients are summarized in Table 1 . The median age of the patients was 78 years (IQR: 71–84 years), and 59% were male. The median body weight was 56.0 kg (IQR: 47.7–63.0 kg). A total of 543 patients (35.5%) had naïve papillae. Diclofenac was administered to 1369 patients (51.2% received 50 mg, 41.8% received 25 mg), whereas 7.1% did not receive diclofenac. The main indications for ERCP included common bile duct stones (45.9%), pancreatic cancer (22.1%), and cholangiocarcinoma (13.3%). Scheduled procedures accounted for 77.5%, whereas 22.6% were emergency procedures. The median cannulation time was 2 minutes, and the median procedure time was 31 minutes (IQR: 20–49 minutes) (Table 1 ). Table 1 Patient characteristics Parameters Total Number of Patients, n 1528 Use of the Medo V-Fix, n (%) 697 (45.6) Patient Factors Age (years) IQR 78 (71, 84) Sex, male, n (%) 904 (59.2) Weight (kg) IQR 56.0 (47.7, 63.0) BMI, IQR 22.0 (19.6, 24.1) Diseases, Malignancies, n (%) 844 (55.2) Common bile duct stone 701 (45.9) Pancreatic cancer 337 (22.1) Cholangiocarcinoma 203 (13.3) Gallbladder cancer 56 (3.7) Other malignant diseases 96 (6.3) ERCP procedure factors Setting, n (%) Emergency/scheduled 345 (22.6)/1139 (77.5) Naïve papilla, n (%) 543 (35.5) Surgically altered anatomy 96 (6.7) Premedication, diclofenac None/25 mg/50 mg, n (%) * 104 (7.1)/615 (41.8)/754 (51.2) Time to reach papilla 3 (2, 6) Intubation time, min 2 (1, 9) Treatment time, min 26 (15, 43) Total procedure time, min 31 (20, 49) Radiation related parameters Fluoroscopy time, min 10 (6, 17) K a,r (mGy) 36.0 (20.9, 62.5) P KA (Gy cm 2 ) 7.4 (4.4, 12.1) No. of images per exam Median 5 (3, 7) IQR; interquartile range, ERCP: endoscopic retrograde cholangiopancreatography *missing data: n=55 Comparison of Outcomes With and Without a Body Positioning Device Table 2 presents the characteristics of the ERCP-related parameters between the device and nondevice groups. There were no significant differences between the two groups in terms of sex, weight, malignant disease prevalence, procedure setting, or the presence of naïve papilla, but the patients were significantly younger (78 vs. 77 years, P = 0.0210) and the cannulation time was longer (3 vs. 2 minutes) in the device group. Table 2 Comparison of ERCP-related parameters and body movement control between the device and nondevice groups. - Use of the Medo V-Fix Without the Medo V-Fix P value Number of Patients 697 831 Patient Factors Age (years) IQR 78 (71, 85) 77 (70, 83) 0.0210 Sex, male, n (%) 427 (61.3) 477 (57.4) 0.1261 Weight (kg) IQR 55.9 (47.9, 63.2) 56.2 (46.9, 63.2) 0.4890 BMI, IQR 22.1 (19.5, 24.1) 22.1 (19.5, 24.1) 0.9498 Disease, Malignancies, n (%) 312 (44.8) 380 (45.7) 0.7059 ERCP procedure factors Setting, n (%) Emergency/scheduled 98/355 194/603 0.2829 Naïve papilla, n (%) 122 (23.4) 253 (32.1) 0.4185 Cannulation time, min 3 (1, 10) 2 (1, 7) 0.0184 Procedure time, min 26 (16, 43) 27 (15, 42) 0.4850 Total procedure time 30 min and more, n (%) 368 (52.8) 441 (53.1) 0.7599 Radiation related procedures Fluoroscopy time 10 (6, 17) 10 (6, 17) 0.9427 K a,r (mGy) 36.0 (21.5, 61.6) 36.0 (20.2, 64.7) 0.8998 P KA (Gy cm 2 ) 7.6 (4.6, 12.6) 7.6 (4.4, 12.7) 0.2347 Body motion evaluation Good/poor/very poor, n (%) 458 (65.7)/167 (24.0)/72 (10.3) 400 (48.1)/255 (30.7)/176 (21.2) < 0.0001 IQR; interquartile range, ERCP: endoscopic retrograde cholangiopancreatography, K a,r : air kerma at the patient irradiation reference point, P KA : area air kerma integrated value Body Movement Control The proportion of patients whose body movement was effectively controlled was significantly greater in the device group than in the nondevice group (good: 65.7% vs. 48.1%, P < 0.0001). Conversely, the proportions of patients whose body movement was poorly and very poorly controlled were significantly greater in the nondevice group than in the device group (poor: 30.7% vs. 24.0%, P = 0.0034; very poor: 21.2% vs. 10.30%, P < 0.0001) (Table 3 ). The Cochran‒Armitage trend test confirmed a significant improvement in body movement control in the device group (P < 0.0001, Fig. 2 ). Table 3 Comparison of patient outcomes between the device and nondevice groups n Good* Poor † Very poor ¶ Use of the Medo V-Fix, n (%) 697 458 (65.7) 167 (24.0) 72 (10.3) Without the Medo V-Fix, n (%) 831 400 (48.1) 255 (30.7) 176 (21.2) * P < 0.0001, compared “good” to the others † P = 0.0034, compared “poor” to the others ¶ P < 0.0001, compared “very poor” to the others Logistic regression analysis was performed to identify factors associated with good body movement control. The univariate analysis revealed that the factors associated with better body movement control were age over 75 years (odds ratio [OR] 1.61, 95% confidence interval [CI]: 1.31–1.98, P < 0.0001), use of the device (OR 2.07, 95% CI: 1.68–2.54, P < 0.0001), emergency setting (OR 1.79, 95% CI: 1.39–2.30, P < 0.0001), and noninitial ERCP (OR 1.46, 95% CI: 1.18–1.81, P = 0.0005). The multivariate analysis revealed that the significant predictors of good body movement control were female sex (OR 1.27, 95% CI: 1.01–1.60, P = 0.0400), age over 75 years (OR 1.27, 95% CI: 1.01–1.60, P = 0.0399), use of the device (OR 1.95, 95% CI: 1.56–2.44, P < 0.0001), emergency setting (OR 1.95, 95% CI: 1.47–2.58, P < 0.0001), and noninitial ERCP (OR 1.51, 95% CI: 1.20–1.90, P = 0.0004). Device use and emergency setting had the highest odds ratios for predicting good body movement control (Table 4 ). Table 4 Factor analysis to predict good body movement control Univariate analysis Multivariate analysis Reference Odds ratio (95% CI) P value Odds ratio (95% CI) P value Sex, Female Male 1.23 (1.00-1.51) 0.0510 1.27 (1.01–1.60) 0.0400 Age, 75 yrs and more Less than 75 yrs 1.61 (1.31–1.98) < 0.0001 1.27 (1.01–1.60) 0.0399 BMI, 25 and more Less than 25 1.28 (0.97–1.68) 0.0801 1.25 (0.93–1.67) 0.1363 Use of the Medo V-Fix Without the device 2.07 (1.68–2.54) < 0.0001 1.95 (1.56–2.44) < 0.0001 ERCP setting, Urgent Scheduled 1.79 (1.39–2.30) < 0.0001 1.95 (1.47–2.58) < 0.0001 Noninitial ERCP Naïve papilla 1.46 (1.18–1.81) 0.0005 1.51 (1.20–1.90) 0.0004 Diseases, Malignancies Begin 1.08 (0.88–1.33) 0.4416 1.16 (0.93–1.46) 0.1915 Surgically altered anatomy Normal 0.89 (0.59–1.34) 0.5726 1.00 (0.63–1.57) 0.9896 ERCP: endoscopic retrograde cholangiopancreatography Additional Sedation Requirements and Procedure Discontinuation- and Sedation-related complications Significantly fewer patients in the device group than in the nondevice group required additional use of thiopental (9.5% vs. 15.6%; P = 0.0003). Additionally, the median dose of thiopental was lower in the device group (4.5 mg) than in the nondevice group (6 mg; P = 0.0015). There were no procedural discontinuations in the device group and five discontinuations in the nondevice group, and the difference was statistically significant (P = 0.0402) (Table 5 ). Table 5 Comparison of the use of sedative and analgesic drugs and the incidence of complications related to sedation between the device and nondevice groups. Use of the Medo V-Fix, n = 697 Without the Medo V-Fix, n = 831 P value Use of sedative and analgesic drugs Dose of midazolam (mg) (IQR) 4 (3, 5) 4 (3, 5) 0.1904 Dose of pethidine (mg) (IQR) 35 (21, 35) 35 (24.5, 35) 0.2564 Use of thiopental, yes, n (%) 66 (9.5) 130 (15.6) 0.0003 Dose of thiopental, (mg) (IQR) 4.5 (3, 8) 6 (4, 9.3) 0.0015 Any sedation-related complications, n (%) 134 (19.2) 104 (12.5) 0.0003 Hypoxia 101 (14.5) 73 (8.8) 0.0005 Hypotension 23 (3.3) 21 (2.5) 0.3683 Bradycardia 13 (1.9) 10 (1.2) 0.2900 Tachycardia 2 (0.3) 5 (0.6) 0.3655 Arrhythmia 1 (0.1) 0 (0) 0.3773 Temporary cardiac arrest 1 (0.1) 0 (0) 0.2747 Interrupted due to body movement 0 (0) 5 (0.6) 0.0402 IQR; interquartile range Sedation-Related Complications and Adverse Events During the study period, no mortalities or severe SRCs were reported. Additionally, no adverse events related to the body positioning device were observed. However, complications occurred significantly more often in the device group than in the nondevice group (19.2% vs. 12.5%, P = 0.0003). Among these SCRs, hypoxia was significantly more common in the device group than in the nondevice group (14.5% vs. 8.8%, P = 0.0005) (Table 4 ). Propensity Score Matching Analysis Multivariate logistic analysis revealed that device use, female sex, age over 75 years, and noninitial ERCP were significant predictors of good body movement control. To further assess the impact of the device, a 1:1 propensity score matching analysis was performed, resulting in 1,246 matched patients. Table 6 shows the results of the propensity score matching analysis. After matching using significant predictors other than device use, there were no significant differences between the two groups in terms of baseline characteristics. However, even after matching, the incidence of SRCs, including hypoxia, was significantly higher and body movement control was significantly better in the device group (Table 6 ). Table 6 Comparison of ERCP-related parameters and body movement control between the device and nondevice groups after propensity score matching. Matched pair Use of the Medo V Without the Medo V P value Number of Patients 623 623 Patient Factors Age (years) IQR 78 (72, 85) 78 (72, 84) 0.6455 Sex, male, n (%) 377 (60.5) 379 (60.8) 0.9538 Use of sedative and analgesic drugs Dose of midazolam (mg) (IQR) 4 (3, 5) 4 (3, 5) 0.3895 Dose of pethidine (mg) (IQR) 35 (21, 35) 10 (24.5, 35) 0.3508 Use of thiopental, yes, n (%) 63 (10.1) 87 (14.0) 0.0450 Dose of thiopental, (mg) (IQR) 5 (3, 8) 6 (4, 9) 0.0132 ERCP procedure factors Setting, Emergency, n (%) 133 (21.4) 135 (21.7) 0.9450 Naïve papilla, n (%) 233 (37.4) 229 (36.8) 0.8603 Procedure time, min 26 (16, 43) 27 (15, 41) 0.3650 Body movement control Good/Poor/Very poor, n (%) 404 (64.9)/154 (24.7)/65 (10.4) 306 (49.1)/198 (31.8)/119 (19.1) < 0.0001 Any sedation-related complications, n (%) 119 (19.1) 78 (12.5) 0.0018 Hypoxia 88 (14.1) 56 (9.0) 0.0029 ERCP: endoscopic retrograde cholangiopancreatography, IQR; interquartile range Procedure and Radiation Metrics No significant differences were observed between the two groups in terms of procedure time, fluoroscopy time, or air kerma dose‒area product (Table 2 ). Discussion The primary finding of this study was that the Medo V-Fix® device significantly improved body movement control during ERCP, increasing procedural safety and efficacy. Good control was achieved for 65.7% in the device group compared with only 48.1% in the nondevice group. The device reduced the need for manual assistance and additional doses of sedatives, as evidenced by fewer patients in the device group requiring thiopental (9.5% vs. 15.6%, P = 0.0003) and the lower median dose of thiopental (4.5 mg vs. 6 mg, P = 0.0015). These findings remained significant after propensity score matching. The results suggest that integrating body-positioning devices into ERCP procedures can significantly improve patient outcomes​. Our findings are consistent with those of Lee et al., who demonstrated that the use of a patient-positioning device during ERCP reduced the required doses of propofol, shortened recovery times, and increased satisfaction among medical staff [ 5 ]​. Similarly, the Medo V-Fix® device not only improved body movement control but also decreased the need for additional doses of sedatives, underscoring that body positioning devices can play a critical role in enhancing the safety and efficiency of ERCP procedures. Adequate sedation and analgesia are crucial for performing ERCP safely, especially given the prone position required for the procedure [ 6 , 7 ]. While benzodiazepines and opioids are commonly used, there is no consensus on the optimal choice of sedatives due to variations in practice environments and available personnel [ 2 , 3 ]. Although propofol is recommended for use by physician who can manage airway [ 8 ], it was not used in this study because of the risk of hypotension and the need for additional anesthesia support. These findings suggest that the Medo V-Fix® device may reduce the overall need for sedatives, potentially reducing the risk of SRCs. Our findings did not support the notion that the use of a body positioning device might preclude the precise manipulation of the endoscope or cause patient discomfort. No adverse events related to the device were reported, and its repeated use did not result in patient refusal or complaints of stress. However, contrary to expectations, SRCs, particularly hypoxemia, were observed more frequently in the device group. The incidence of SRCs remained unchanged even after adjusting for background factors such as age through propensity score matching. A possible explanation is that the device restricted chest and abdominal movements and therefore respiratory movements, even though there was no difference in the amount of sedatives used. Additionally, the stable body position achieved with the device may have contributed to relatively excessive sedation. In this study, the incidence of SRCs was extracted from nursing records, so the exact timing of hypoxemia is unclear. Furthermore, some cases of hypoxemia were observed even before the initiation of the body positioning device, highlighting the need for future prospective studies. Nevertheless, since no severe SRCs were observed in the device group, this study demonstrated that the benefits of using the device for improved body movement control outweigh the risks. In the future, research intended to ascertain whether the use of body positioning devices, particularly in elderly patients, can reduce the amount of sedatives needed for adequate sedation is needed. Patients and surgical staff are exposed to high doses of radiation during ERCP [ 9 , 10 ]; however, it is worth mentioning that radiation doses vary across institutions owing to differences in procedural complexity and advanced equipment used [ 11 , 12 ]. Although no significant differences in fluoroscopy metrics were observed between the groups, the Medo V-Fix® device reduced the incidence of very poor body movement control, and very poor body movement control often requires manual stabilization near the radiation tube (10.3% vs. 21.2%, P < 0.001). Consequently, staff may be exposed to lower doses of radiation, thus reducing risks associated with radiation exposure. Factors predicting good body movement control were analyzed using multivariate analysis and included female sex, device use, emergency setting, and noninitial ERCP. The results demonstrated that device use was significantly associated with improved body movement control, even after adjusting for pretest factors. These findings suggest that the benefits of using a body positioning device may extend beyond simple physical immobilization. However, the Medo V-Fix® device has limitations, particularly in stabilizing the head. In the event of inadequate sedation, the patient may attempt to move their heads, thus necessitating manual immobilization. Additionally, the device may be insufficiently durable, thus precluding its repeated use. This study has several limitations. First, as a single-center retrospective study, the findings may not be generalizable to other settings. However, the inclusion of over 500 procedures involving the use of the Medo V-Fix® device strengthens the validity of the results. Second, the evaluation of body movement control was subjective and varied among examiners, which may have affected the accuracy of the comparisons. Conclusion In conclusion, the use of the Medo V-Fix® body positioning device significantly enhances body movement control and reduces the need for additional sedatives, thereby improving procedural safety and efficiency. Notably, the use of the device reduced the incidence of very poor body movement control by 50%, substantially reducing the need for manual intervention during the procedure. These findings support the integration of body-positioning devices into standard ERCP practices to enhance patient outcomes. Declarations Disclosures Dr. Haruka Masuda, Dr. Tsutomu Nishida, Dr. Kengo Matsumoto, Dr. Dai Nakamatsu, Dr. Shiro Hayashi, and Dr. Masashi Yamamoto have no conflicts of interest or financial ties to disclose. Acknowledgments We would like to express our gratitude to Dr. Kazuhide Iwasa, Dr. Hiroki Takiyama, Dr. Yuhiko Katanosaka, Dr. Asuka Watanabe, Dr. Naohiro Sakamoto, Dr. Satoru Okabe, Dr. Yoshifumi Fujii, Dr. Naoto Osugi, Dr. Aya Sugimoto, and Dr. Koji Fukui from the Department of Gastroenterology at Toyonaka Municipal Hospital for their support and assistance during this study. 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Am J Gastroenterol 107:1495–1501 quiz 1494, 1502 Lee S, Han JH, Lee HS, Kim KB, Lee IK, Cha EJ, Shin YD, Park N, Park SM (2015) Efficacy and safety of a patient-positioning device (EZ-FIX) for endoscopic retrograde cholangiopancreatography. World J Gastroenterol 21:5995–6000 Haytural C, Aydinli B, Demir B, Bozkurt E, Parlak E, Disibeyaz S, Sarac A, Ozgok A, Kazanci D (2015) Comparison of Propofol, Propofol-Remifentanil, and Propofol-Fentanyl Administrations with Each Other Used for the Sedation of Patients to Undergo ERCP. Biomed Res Int 2015:465465 Sugiarto A, Kapuangan C, Tantri AR, Chrisnata V (2020) Effectivity of benzydamine hydrochloride gargle to reduce propofol consumption in endoscopic retrograde cholangiopancreatography procedure: a randomized controlled trial. 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PLoS ONE 13:e0207539 Hayashi S, Takenaka M, Hosono M, Kogure H, Hasatani K, Suda T, Maruyama H, Matsunaga K, Ihara H, Yoshio T, Nagaike K, Yamada T, Yakushijin T, Takagi T, Tsumura H, Kurita A, Asai S, Ito Y, Kuwai T, Hori Y, Maetani I, Ikezawa K, Iwashita T, Matsumoto K, Fujisawa T, Nishida T (2022) Diagnostic Reference Levels for Fluoroscopy-guided Gastrointestinal Procedures in Japan from the REX-GI Study: A Nationwide Multicentre Prospective Observational Study. Lancet Reg Health West Pac 20:100376 Hayashi S, Nishida T, Osugi N, Yamaoka S, Sugimoto A, Mukai K, Nakamatsu D, Matsumoto K, Yamamoto M, Fukui K, Takenaka M, Hosono M, Inada M (2021) Time Trend of the Radiation Exposure Dose in Endoscopic Retrograde Cholangiopancreatography Over an 8-Year Period: A Single-Center Retrospective Study. Am J Gastroenterol 116:100–105 Additional Declarations The authors declare no competing interests. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5423780","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":376150515,"identity":"1fcc98c6-4b83-42f5-b0eb-dce6738fa923","order_by":0,"name":"Haruka Masuda","email":"","orcid":"https://orcid.org/0009-0000-9536-1068","institution":"Toyonaka Municipal Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Haruka","middleName":"","lastName":"Masuda","suffix":""},{"id":376151683,"identity":"9c6fa6e7-3f35-49c7-aba9-8e2852a6252e","order_by":1,"name":"Tsutomu Nishida","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABDklEQVRIiWNgGAWjYFACxgZmBgNmOFcORBx4gEcDD4qWAwwMxmA6Aa8WBgZmMIJqSWwAMfBpsZdubv5cUGAtz8C/+PHnj3ts0ueHHX4ItMVOTrcBhy0yB9ukZxikGzZIPDOTOPAsLXfj7TQDoJZkY7MDOLRIJLYx8xgcZmyQOGDGcODA4dyNsxNAWg4kbsOtpfkzUIt9g8Txzx+AWtINZ6d/IKSlQRqoJbGBv8dAAqglQV46h4AtNxLbgFrSk9skeMokzhxIM9wgnVNwIMEAt1/YZ6Q//szzx9q2n//45g8VB2zk5Wenb/7wocJODpcWOGCTSIAwDMAqDQgoBwN+qKHyDcSoHgWjYBSMgpEEAPU5Yr/Jhr9HAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0003-4037-9003","institution":"Toyonaka Municipal Hospital","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Tsutomu","middleName":"","lastName":"Nishida","suffix":""},{"id":376151684,"identity":"b676ac49-0402-4cc7-8b58-1602079ae4c8","order_by":2,"name":"Kengo Matsumoto","email":"","orcid":"https://orcid.org/0000-0002-1074-026X","institution":"Toyonaka Municipal Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Kengo","middleName":"","lastName":"Matsumoto","suffix":""},{"id":376151685,"identity":"82351ff6-6993-4d80-be6c-fb62baec4da5","order_by":3,"name":"Dai Nakamatsu","email":"","orcid":"https://orcid.org/0000-0002-4681-4187","institution":"Toyonaka Municipal Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Dai","middleName":"","lastName":"Nakamatsu","suffix":""},{"id":376151686,"identity":"cd5eeb42-3052-42c4-98ed-a729736cd021","order_by":4,"name":"Shiro Hayashi","email":"","orcid":"https://orcid.org/0000-0003-4533-2976","institution":"Toyonaka Municipal Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Shiro","middleName":"","lastName":"Hayashi","suffix":""},{"id":376151688,"identity":"2c42e9c7-22e9-4145-b37c-19415ec296b3","order_by":5,"name":"Masashi Yamamoto","email":"","orcid":"https://orcid.org/0000-0002-1107-6858","institution":"Toyonaka Municipal Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Masashi","middleName":"","lastName":"Yamamoto","suffix":""}],"badges":[],"createdAt":"2024-11-10 00:39:34","currentVersionCode":1,"declarations":{"humanSubjects":false,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":false,"humanSubjectConsent":false,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false,"coiExplicitlySet":false},"doi":"10.21203/rs.3.rs-5423780/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5423780/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":68868749,"identity":"4ddb177f-2c08-4208-ab35-bdfb3253a880","added_by":"auto","created_at":"2024-11-13 02:32:40","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":3888575,"visible":true,"origin":"","legend":"\u003cp\u003eThe Medo V-Fix® body positioning device.\u003c/p\u003e\n\u003cp\u003eThis specialized device secures patients during endoscopic procedures, ensuring stability and comfort (A). It allows for precise positioning and reduces movement, which can compromise procedural accuracy and safety. The Medo V-Fix® is adjustable to fit various patient sizes, ensuring optimal immobilization without causing discomfort (B). It is an essential tool for enhancing procedural efficiency and improving the overall quality of endoscopic examinations.\u003c/p\u003e","description":"","filename":"Fig.1.png","url":"https://assets-eu.researchsquare.com/files/rs-5423780/v1/51a9bd9ea0bd5b0a754d26ab.png"},{"id":68868747,"identity":"1f2e58b3-a6a7-4cce-b2f5-83487c104b34","added_by":"auto","created_at":"2024-11-13 02:32:39","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":78059,"visible":true,"origin":"","legend":"\u003cp\u003eTrend analysis of body movement control in the device and nondevice groups.\u003c/p\u003e","description":"","filename":"Fig.2.png","url":"https://assets-eu.researchsquare.com/files/rs-5423780/v1/6b591a5c6a2e16dfe417bc15.png"},{"id":68869494,"identity":"2d224b85-5afe-45ba-b72a-6a6678fea3d5","added_by":"auto","created_at":"2024-11-13 02:40:41","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":4377815,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5423780/v1/5c36791a-1e73-4ffa-a167-0d614fe95c6c.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003eThe Effectiveness of a Body Positioning Device for Controlling Patient Movement and Additional Sedative Use during ERCP: A Retrospective Analysis\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eEndoscopic retrograde cholangiopancreatography (ERCP) is a complex and technically demanding procedure that requires precise patient safety measures and procedural accuracy [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Uncontrolled patient movement during ERCP significantly increases the risk of complications and decreases the safety and efficiency of the procedure. To mitigate this risk, sedatives are typically administered to stabilize patients [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. However, in elderly patients, the use of sedatives increase the risk of sedation-related complications (SRCs) [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Furthermore, according to most guidelines, an anesthesiologist is recommended to oversee procedures involving patients with multiple medical comorbidities and those considered to have airways that are difficult to manage [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. This additional requirement may limit the use of alternative methods for effectively controlling patient movement.\u003c/p\u003e \u003cp\u003eGiven these challenges, physical restraints are promising alternatives for controlling patient movement during ERCP. Restraints can restrict patient movement, thereby enhancing the safety and precision of the procedure. Despite the risk of complications, the benefits outweigh the risks, and patients should also receive education and provide consent prior to undergoing the procedure. Studies suggest that physical restraints may reduce the need for sedatives and shorten the recovery time [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]​​, which is particularly beneficial for elderly patients.\u003c/p\u003e \u003cp\u003eMedo V-Fix\u0026reg; (Century Medical Inc., Tokyo, Japan) is a body positioning device that was designed to improve patient stability during endoscopic procedures and introduced in August 2020. This user-friendly device is similar to other devices, such as the EZ-FIX\u0026reg; [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]​. This study retrospectively evaluated the effectiveness of the Medo V-Fix\u0026reg; device during ERCP, focusing on its impact on body movement control, patient safety, and need for sedatives.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n\u003ch2\u003ePatients\u003c/h2\u003e\n\u003cp\u003eThis single-center retrospective observational study was conducted using data from ERCP procedures consecutively performed at Toyonaka Municipal Hospital between January 2021 and March 2024. Among the 1,723 ERCP procedures reviewed, 195 cases were excluded because of incomplete data, resulting in 1528 cases for the final analysis. The study population was divided into two groups: the device group (n\u0026thinsp;=\u0026thinsp;697) and the nondevice group (n\u0026thinsp;=\u0026thinsp;831). Owing to the limited availability of the device, some procedures were conducted without it, resulting in a mixed sample.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eEthics\u003c/h3\u003e\n\u003cp\u003eThe study protocol adhered to the principles of the Declaration of Helsinki and was approved by the Ethics Committee of Toyonaka Municipal Hospital (2024-05-02). As this was a retrospective study using previously collected personal data, the need for informed consent was waived through the opt-out method on our hospital's website.\u003c/p\u003e\n\u003ch3\u003eBody Positioning Device\u003c/h3\u003e\n\u003cp\u003eThe Medo V-Fix\u0026reg; device (Century Medical Inc., Tokyo, Japan) is a body positioning device that was introduced in November 2022 to increase patient stability during ERCP. This device involves the use of a mattress filled with beads that conform to the patient's body shape, distributing body pressure. By pressing a switch on a dedicated compressor, air is released from the mattress, causing it to harden through moderate decompression, thus maintaining the patient's body position. The compressor stops automatically with moderate decompression during this process, so the patient does not experience excessive pressure. If necessary, the mattress can be reinflated during the procedure, and the compressor will automatically reactivate, maintaining the desired level of immobilization. After the procedure, turning off and disconnecting the compressor quickly allows the mattress to return to its softened state. In some cases, the patient is temporarily positioned on their side for scope insertion, so the device can be used after the endoscope reached the papilla of Vater. In this study, the patient's consent to use the fixation device was obtained in writing before the examination, and the procedure was performed.\u003c/p\u003e\n\u003ch3\u003eERCP Procedure\u003c/h3\u003e\n\u003cp\u003eERCP was performed by trainees under the supervision of experts or experienced endoscopists at Toyonaka Municipal Hospital, a JGES-certified teaching hospital. Cannulation was performed using a wire loading method with a side-viewing duodenoscope (TJF-Q290V; Olympus Optical Co., Tokyo, Japan; ED-580T; Fujifilm, Tokyo, Japan). Diclofenac was administered rectally to prevent post-ERCP pancreatitis, and the dosage was adjusted according to body weight (25 mg or 50 mg), provided that there were no contraindications.\u003c/p\u003e\n\u003ch3\u003eSedation and Analgesia\u003c/h3\u003e\n\u003cp\u003eSedation was achieved with midazolam and pethidine hydrochloride. The initial dose of midazolam ranged from 2 mg to 3 mg, adjusted for patient weight and age. The initial dose of pethidine ranged from 7 mg to 10.5 mg, and an additional dose was provided as needed. Thiopental was used when midazolam or pethidine was insufficient for adequate sedation.\u003c/p\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n\u003ch2\u003eMonitoring During ERCP\u003c/h2\u003e\n\u003cp\u003eDuring ERCP, patients were monitored by at least one nurse, the endoscopist and an assistant. If significant patient movement compromised monitoring, an additional nurse was brought in, or the procedure was discontinued. During the examination, the nurse monitored the patient's general condition, breathing, blood pressure, heart rate and saturation of percutaneous oxygen (SpO₂), recorded the patient\u0026rsquo;s progress and any SRCs in the nursing records.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eBody Motion Evaluation\u003c/h3\u003e\n\u003cp\u003eBody movement control was categorized into three grades:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eGood: Patient movement was effectively controlled with the scheduled dose of sedatives.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePoor: Patient movement was controlled with higher-than- scheduled doses of sedatives.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eVery Poor: Patient movement was controlled with the assistance of additional personnel despite additional doses of sedatives.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003ch3\u003eOutcomes\u003c/h3\u003e\n\u003cp\u003eThe primary outcome was the grade of body movement control during ERCP. The secondary outcomes included the total dose of sedatives administered, the rate of procedure discontinuation due to inadequate movement control and the incidence of SRCs, such as hypoxia, hypotension and bradycardia. As data regarding SRCs were obtained retrospectively from nursing records, it is difficult to ascertain whether their documentation was objective or accurate. However, hypoxemia was diagnosed on the basis of decreases in SpO₂ from the start of treatment and the need for oxygen administration. Hypotension was diagnosed on the basis of a drop in blood pressure below 90 mmHg from baseline or the need for intravenous fluid administration. Bradycardia was diagnosed on the basis of a heart rate less than 50 beats per minute. Additional outcomes included procedure duration and radiation exposure metrics such as fluoroscopy time and the air kerma dose‒area product.\u003c/p\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n\u003ch2\u003eStatistical Analysis\u003c/h2\u003e\n\u003cp\u003eContinuous variables are expressed as medians and interquartile ranges (IQRs), and categorical variables are presented as counts and percentages. Sample size calculations were not performed because of the retrospective nature of the study and the lack of prior evidence on which to base them. The Wilcoxon test was used to compare continuous variables, and categorical variables were compared using the \u0026chi;\u0026sup2; test or Fisher\u0026rsquo;s exact test, as appropriate. Trends in body movement control (good/poor/very poor) were assessed using the Cochran‒Armitage trend test. Bonferroni correction was applied to adjust for multiple comparisons, and a P value\u0026thinsp;\u0026lt;\u0026thinsp;0.0167 was indicative of statistical significance.\u003c/p\u003e\n\u003cp\u003eLogistic regression analysis was conducted to identify predictive factors of good body movement control, with seven variables evaluated: sex, age 75 years or older, BMI of 25 or higher, device use, emergency setting, first papilla, benign disease or malignancies, and postoperative stomach status. Propensity scores for good body movement control were calculated using these significant factors in a multiple logistic analysis, and a 1:1 matched study group was created with a caliper width of 0.05 to minimize selection bias. The device and nondevice groups were compared. A p value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 indicated statistical significance. Analyses were performed using JMP software (version 17.0.0, SAS Institute, Cary, NC, USA).\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n \u003ch2\u003ePatient characteristics and basic ERCP-related parameters\u003c/h2\u003e\n \u003cp\u003eThe baseline characteristics of the patients are summarized in Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e. The median age of the patients was 78 years (IQR: 71\u0026ndash;84 years), and 59% were male. The median body weight was 56.0 kg (IQR: 47.7\u0026ndash;63.0 kg). A total of 543 patients (35.5%) had na\u0026iuml;ve papillae. Diclofenac was administered to 1369 patients (51.2% received 50 mg, 41.8% received 25 mg), whereas 7.1% did not receive diclofenac. The main indications for ERCP included common bile duct stones (45.9%), pancreatic cancer (22.1%), and cholangiocarcinoma (13.3%). Scheduled procedures accounted for 77.5%, whereas 22.6% were emergency procedures. The median cannulation time was 2 minutes, and the median procedure time was 31 minutes (IQR: 20\u0026ndash;49 minutes) (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\n \u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003ePatient characteristics\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003cem\u003eParameters\u003c/em\u003e\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eTotal\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNumber of Patients, n\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1528\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUse of the Medo V-Fix, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e697 (45.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatient Factors\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAge (years) IQR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e78 (71, 84)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSex, male, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e904 (59.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eWeight (kg) IQR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e56.0 (47.7, 63.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBMI, IQR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e22.0 (19.6, 24.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDiseases, Malignancies, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e844 (55.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCommon bile duct stone\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e701 (45.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePancreatic cancer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e337 (22.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCholangiocarcinoma\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e203 (13.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eGallbladder cancer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e56 (3.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eOther malignant diseases\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e96 (6.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eERCP procedure factors\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSetting, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eEmergency/scheduled\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e345 (22.6)/1139 (77.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNa\u0026iuml;ve papilla, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e543 (35.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSurgically altered anatomy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e96 (6.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePremedication, diclofenac\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNone/25 mg/50 mg, n (%) *\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e104 (7.1)/615 (41.8)/754 (51.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTime to reach papilla\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3 (2, 6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eIntubation time, min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2 (1, 9)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTreatment time, min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e26 (15, 43)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTotal procedure time, min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e31 (20, 49)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRadiation related parameters\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFluoroscopy time, min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10 (6, 17)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003eK\u003c/em\u003e \u003csub\u003ea,r\u003c/sub\u003e (mGy)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36.0 (20.9, 62.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e \u003csub\u003eKA\u003c/sub\u003e (Gy\u0026thinsp;cm\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7.4 (4.4, 12.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNo. of images per exam Median\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (3, 7)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cdiv class=\"gridtable\"\u003e\n \u003cdiv class=\"colspec\" align=\"left\"\u003e\n \u003cp\u003eIQR; interquartile range, ERCP: endoscopic retrograde cholangiopancreatography\u003c/p\u003e\n \u003cp\u003e*missing data: n=55\u003c/p\u003e\n \u003c/div\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\n \u003ch2\u003eComparison of Outcomes With and Without a Body Positioning Device\u003c/h2\u003e\n \u003cp\u003eTable\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e presents the characteristics of the ERCP-related parameters between the device and nondevice groups. There were no significant differences between the two groups in terms of sex, weight, malignant disease prevalence, procedure setting, or the presence of na\u0026iuml;ve papilla, but the patients were significantly younger (78 vs. 77 years, P\u0026thinsp;=\u0026thinsp;0.0210) and the cannulation time was longer (3 vs. 2 minutes) in the device group.\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\n \u003cdiv class=\"colspec\" align=\"char\"\u003e\u0026nbsp;\u003c/div\u003e\n \u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eComparison of ERCP-related parameters and body movement control between the device and nondevice groups. -\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eUse of the Medo V-Fix\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eWithout the Medo V-Fix\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003eP value\u003c/em\u003e\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNumber of Patients\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e697\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e831\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatient Factors\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAge (years) IQR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e78 (71, 85)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e77 (70, 83)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.0210\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSex, male, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e427 (61.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e477 (57.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.1261\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eWeight (kg) IQR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e55.9 (47.9, 63.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e56.2 (46.9, 63.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.4890\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBMI, IQR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e22.1 (19.5, 24.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e22.1 (19.5, 24.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.9498\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDisease, Malignancies, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e312 (44.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e380 (45.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.7059\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eERCP procedure factors\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSetting, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eEmergency/scheduled\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e98/355\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e194/603\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.2829\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNa\u0026iuml;ve papilla, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e122 (23.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e253 (32.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.4185\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCannulation time, min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3 (1, 10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2 (1, 7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.0184\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eProcedure time, min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e26 (16, 43)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e27 (15, 42)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.4850\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTotal procedure time 30 min and more, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e368 (52.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e441 (53.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.7599\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRadiation related procedures\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFluoroscopy time\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10 (6, 17)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10 (6, 17)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.9427\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003eK\u003c/em\u003e \u003csub\u003ea,r\u003c/sub\u003e (mGy)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36.0 (21.5, 61.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36.0 (20.2, 64.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.8998\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e \u003csub\u003eKA\u003c/sub\u003e (Gy\u0026thinsp;cm\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7.6 (4.6, 12.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7.6 (4.4, 12.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.2347\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBody motion evaluation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eGood/poor/very poor, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e458 (65.7)/167 (24.0)/72 (10.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e400 (48.1)/255 (30.7)/176 (21.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\"\u003eIQR; interquartile range, ERCP: endoscopic retrograde cholangiopancreatography, K\u003csub\u003ea,r\u003c/sub\u003e: air kerma at the patient irradiation reference point, P\u003csub\u003eKA\u003c/sub\u003e: area air kerma integrated value\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\n \u003ch2\u003eBody Movement Control\u003c/h2\u003e\n \u003cp\u003eThe proportion of patients whose body movement was effectively controlled was significantly greater in the device group than in the nondevice group (good: 65.7% vs. 48.1%, P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001). Conversely, the proportions of patients whose body movement was poorly and very poorly controlled were significantly greater in the nondevice group than in the device group (poor: 30.7% vs. 24.0%, P\u0026thinsp;=\u0026thinsp;0.0034; very poor: 21.2% vs. 10.30%, P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e). The Cochran‒Armitage trend test confirmed a significant improvement in body movement control in the device group (P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001, Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\n \u003cdiv class=\"colspec\" align=\"char\"\u003e\u0026nbsp;\u003c/div\u003e\n \u003cdiv class=\"colspec\" align=\"char\"\u003e\u0026nbsp;\u003c/div\u003e\n \u003cdiv class=\"colspec\" align=\"char\"\u003e\u0026nbsp;\u003c/div\u003e\n \u003cdiv class=\"colspec\" align=\"char\"\u003e\u0026nbsp;\u003c/div\u003e\n \u003ctable id=\"Tab3\" border=\"1\"\u003e\n \u003ccaption\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eComparison of patient outcomes between the device and nondevice groups\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003en\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eGood*\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ePoor\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eVery poor\u003csup\u003e\u0026para;\u003c/sup\u003e\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUse of the Medo V-Fix, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e697\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e458 (65.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e167 (24.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e72 (10.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eWithout the Medo V-Fix, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e831\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e400 (48.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e255 (30.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e176 (21.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\"\u003e\u003csup\u003e*\u003c/sup\u003e P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001, compared \u0026ldquo;good\u0026rdquo; to the others\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\"\u003e\u003csup\u003e\u0026dagger;\u003c/sup\u003eP\u0026thinsp;=\u0026thinsp;0.0034, compared \u0026ldquo;poor\u0026rdquo; to the others\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\"\u003e\u003csup\u003e\u0026para;\u003c/sup\u003eP\u0026thinsp;\u0026lt;\u0026thinsp;0.0001, compared \u0026ldquo;very poor\u0026rdquo; to the others\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003e\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eLogistic regression analysis was performed to identify factors associated with good body movement control. The univariate analysis revealed that the factors associated with better body movement control were age over 75 years (odds ratio [OR] 1.61, 95% confidence interval [CI]: 1.31\u0026ndash;1.98, P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001), use of the device (OR 2.07, 95% CI: 1.68\u0026ndash;2.54, P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001), emergency setting (OR 1.79, 95% CI: 1.39\u0026ndash;2.30, P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001), and noninitial ERCP (OR 1.46, 95% CI: 1.18\u0026ndash;1.81, P\u0026thinsp;=\u0026thinsp;0.0005).\u003c/p\u003e\n \u003cp\u003eThe multivariate analysis revealed that the significant predictors of good body movement control were female sex (OR 1.27, 95% CI: 1.01\u0026ndash;1.60, P\u0026thinsp;=\u0026thinsp;0.0400), age over 75 years (OR 1.27, 95% CI: 1.01\u0026ndash;1.60, P\u0026thinsp;=\u0026thinsp;0.0399), use of the device (OR 1.95, 95% CI: 1.56\u0026ndash;2.44, P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001), emergency setting (OR 1.95, 95% CI: 1.47\u0026ndash;2.58, P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001), and noninitial ERCP (OR 1.51, 95% CI: 1.20\u0026ndash;1.90, P\u0026thinsp;=\u0026thinsp;0.0004). Device use and emergency setting had the highest odds ratios for predicting good body movement control (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\n \u003ctable id=\"Tab4\" border=\"1\"\u003e\n \u003ccaption\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eFactor analysis to predict good body movement control\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eUnivariate analysis\u003c/p\u003e\n \u003c/th\u003e\n \u003cth colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eMultivariate analysis\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eReference\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eOdds ratio (95% CI)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eOdds ratio (95% CI)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSex, Female\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.23 (1.00-1.51)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0510\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.27 (1.01\u0026ndash;1.60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0400\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAge, 75 yrs and more\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eLess than 75 yrs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.61 (1.31\u0026ndash;1.98)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.27 (1.01\u0026ndash;1.60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0399\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBMI, 25 and more\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eLess than 25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.28 (0.97\u0026ndash;1.68)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0801\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.25 (0.93\u0026ndash;1.67)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.1363\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUse of the Medo V-Fix\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eWithout the device\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2.07 (1.68\u0026ndash;2.54)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.95 (1.56\u0026ndash;2.44)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eERCP setting, Urgent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eScheduled\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.79 (1.39\u0026ndash;2.30)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.95 (1.47\u0026ndash;2.58)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNoninitial ERCP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNa\u0026iuml;ve papilla\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.46 (1.18\u0026ndash;1.81)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0005\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.51 (1.20\u0026ndash;1.90)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0004\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDiseases, Malignancies\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBegin\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.08 (0.88\u0026ndash;1.33)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.4416\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.16 (0.93\u0026ndash;1.46)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.1915\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSurgically altered anatomy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNormal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.89 (0.59\u0026ndash;1.34)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.5726\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.00 (0.63\u0026ndash;1.57)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.9896\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\"\u003eERCP: endoscopic retrograde cholangiopancreatography\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\n \u003ch2\u003eAdditional Sedation Requirements and Procedure Discontinuation- and Sedation-related complications\u003c/h2\u003e\n \u003cp\u003eSignificantly fewer patients in the device group than in the nondevice group required additional use of thiopental (9.5% vs. 15.6%; P\u0026thinsp;=\u0026thinsp;0.0003). Additionally, the median dose of thiopental was lower in the device group (4.5 mg) than in the nondevice group (6 mg; P\u0026thinsp;=\u0026thinsp;0.0015). There were no procedural discontinuations in the device group and five discontinuations in the nondevice group, and the difference was statistically significant (P\u0026thinsp;=\u0026thinsp;0.0402) (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\n \u003ctable id=\"Tab5\" border=\"1\"\u003e\n \u003ccaption\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eComparison of the use of sedative and analgesic drugs and the incidence of complications related to sedation between the device and nondevice groups.\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eUse of the Medo V-Fix, n\u0026thinsp;=\u0026thinsp;697\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eWithout the Medo V-Fix, n\u0026thinsp;=\u0026thinsp;831\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003eP value\u003c/em\u003e\u003c/p\u003e\n \u003c/th\u003e\n \u003cth colspan=\"1\" align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eUse of sedative and analgesic drugs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eDose of midazolam (mg) (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (3, 5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (3, 5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.1904\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eDose of pethidine (mg) (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e35 (21, 35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e35 (24.5, 35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.2564\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eUse of thiopental, yes, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e66 (9.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e130 (15.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0003\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eDose of thiopental, (mg) (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.5 (3, 8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6 (4, 9.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0015\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eAny sedation-related complications, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e134 (19.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e104 (12.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0003\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eHypoxia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e101 (14.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e73 (8.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0005\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eHypotension\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e23 (3.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e21 (2.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.3683\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eBradycardia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e13 (1.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10 (1.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.2900\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eTachycardia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2 (0.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (0.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.3655\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eArrhythmia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (0.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.3773\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eTemporary cardiac arrest\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (0.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.2747\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eInterrupted due to body movement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (0.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0402\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\"\u003eIQR; interquartile range\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\n \u003ch2\u003eSedation-Related Complications and Adverse Events\u003c/h2\u003e\n \u003cp\u003eDuring the study period, no mortalities or severe SRCs were reported. Additionally, no adverse events related to the body positioning device were observed. However, complications occurred significantly more often in the device group than in the nondevice group (19.2% vs. 12.5%, P\u0026thinsp;=\u0026thinsp;0.0003). Among these SCRs, hypoxia was significantly more common in the device group than in the nondevice group (14.5% vs. 8.8%, P\u0026thinsp;=\u0026thinsp;0.0005) (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\n \u003ch2\u003ePropensity Score Matching Analysis\u003c/h2\u003e\n \u003cp\u003eMultivariate logistic analysis revealed that device use, female sex, age over 75 years, and noninitial ERCP were significant predictors of good body movement control. To further assess the impact of the device, a 1:1 propensity score matching analysis was performed, resulting in 1,246 matched patients. Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e6\u003c/span\u003e shows the results of the propensity score matching analysis. After matching using significant predictors other than device use, there were no significant differences between the two groups in terms of baseline characteristics. However, even after matching, the incidence of SRCs, including hypoxia, was significantly higher and body movement control was significantly better in the device group (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\n \u003ctable id=\"Tab6\" border=\"1\"\u003e\n \u003ccaption\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 6\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eComparison of ERCP-related parameters and body movement control between the device and nondevice groups after propensity score matching.\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth colspan=\"2\" align=\"left\"\u003e\n \u003cp\u003eMatched pair\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUse of the Medo V\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eWithout the Medo V\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003eP value\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNumber of Patients\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e623\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e623\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatient Factors\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAge (years) IQR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e78 (72, 85)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e78 (72, 84)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.6455\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSex, male, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e377 (60.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e379 (60.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.9538\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUse of sedative and analgesic drugs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDose of midazolam (mg) (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (3, 5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (3, 5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.3895\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDose of pethidine (mg) (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e35 (21, 35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10 (24.5, 35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.3508\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUse of thiopental, yes, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e63 (10.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e87 (14.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0450\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDose of thiopental, (mg) (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (3, 8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6 (4, 9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0132\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eERCP procedure factors\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSetting, Emergency, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e133 (21.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e135 (21.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.9450\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNa\u0026iuml;ve papilla, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e233 (37.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e229 (36.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.8603\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eProcedure time, min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e26 (16, 43)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e27 (15, 41)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.3650\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBody movement control\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eGood/Poor/Very poor, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e404 (64.9)/154 (24.7)/65 (10.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e306 (49.1)/198 (31.8)/119 (19.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAny sedation-related complications, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e119 (19.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e78 (12.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0018\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eHypoxia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e88 (14.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e56 (9.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.0029\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\"\u003eERCP: endoscopic retrograde cholangiopancreatography, IQR; interquartile range\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec19\" class=\"Section2\"\u003e\n \u003ch2\u003eProcedure and Radiation Metrics\u003c/h2\u003e\n \u003cp\u003eNo significant differences were observed between the two groups in terms of procedure time, fluoroscopy time, or air kerma dose‒area product (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe primary finding of this study was that the Medo V-Fix\u0026reg; device significantly improved body movement control during ERCP, increasing procedural safety and efficacy. Good control was achieved for 65.7% in the device group compared with only 48.1% in the nondevice group. The device reduced the need for manual assistance and additional doses of sedatives, as evidenced by fewer patients in the device group requiring thiopental (9.5% vs. 15.6%, P\u0026thinsp;=\u0026thinsp;0.0003) and the lower median dose of thiopental (4.5 mg vs. 6 mg, P\u0026thinsp;=\u0026thinsp;0.0015). These findings remained significant after propensity score matching. The results suggest that integrating body-positioning devices into ERCP procedures can significantly improve patient outcomes​.\u003c/p\u003e \u003cp\u003eOur findings are consistent with those of Lee et al., who demonstrated that the use of a patient-positioning device during ERCP reduced the required doses of propofol, shortened recovery times, and increased satisfaction among medical staff [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]​. Similarly, the Medo V-Fix\u0026reg; device not only improved body movement control but also decreased the need for additional doses of sedatives, underscoring that body positioning devices can play a critical role in enhancing the safety and efficiency of ERCP procedures.\u003c/p\u003e \u003cp\u003eAdequate sedation and analgesia are crucial for performing ERCP safely, especially given the prone position required for the procedure [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. While benzodiazepines and opioids are commonly used, there is no consensus on the optimal choice of sedatives due to variations in practice environments and available personnel [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Although propofol is recommended for use by physician who can manage airway [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e], it was not used in this study because of the risk of hypotension and the need for additional anesthesia support. These findings suggest that the Medo V-Fix\u0026reg; device may reduce the overall need for sedatives, potentially reducing the risk of SRCs.\u003c/p\u003e \u003cp\u003eOur findings did not support the notion that the use of a body positioning device might preclude the precise manipulation of the endoscope or cause patient discomfort. No adverse events related to the device were reported, and its repeated use did not result in patient refusal or complaints of stress. However, contrary to expectations, SRCs, particularly hypoxemia, were observed more frequently in the device group. The incidence of SRCs remained unchanged even after adjusting for background factors such as age through propensity score matching. A possible explanation is that the device restricted chest and abdominal movements and therefore respiratory movements, even though there was no difference in the amount of sedatives used. Additionally, the stable body position achieved with the device may have contributed to relatively excessive sedation.\u003c/p\u003e \u003cp\u003eIn this study, the incidence of SRCs was extracted from nursing records, so the exact timing of hypoxemia is unclear. Furthermore, some cases of hypoxemia were observed even before the initiation of the body positioning device, highlighting the need for future prospective studies. Nevertheless, since no severe SRCs were observed in the device group, this study demonstrated that the benefits of using the device for improved body movement control outweigh the risks. In the future, research intended to ascertain whether the use of body positioning devices, particularly in elderly patients, can reduce the amount of sedatives needed for adequate sedation is needed.\u003c/p\u003e \u003cp\u003ePatients and surgical staff are exposed to high doses of radiation during ERCP [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]; however, it is worth mentioning that radiation doses vary across institutions owing to differences in procedural complexity and advanced equipment used [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Although no significant differences in fluoroscopy metrics were observed between the groups, the Medo V-Fix\u0026reg; device reduced the incidence of very poor body movement control, and very poor body movement control often requires manual stabilization near the radiation tube (10.3% vs. 21.2%, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Consequently, staff may be exposed to lower doses of radiation, thus reducing risks associated with radiation exposure.\u003c/p\u003e \u003cp\u003eFactors predicting good body movement control were analyzed using multivariate analysis and included female sex, device use, emergency setting, and noninitial ERCP. The results demonstrated that device use was significantly associated with improved body movement control, even after adjusting for pretest factors. These findings suggest that the benefits of using a body positioning device may extend beyond simple physical immobilization.\u003c/p\u003e \u003cp\u003eHowever, the Medo V-Fix\u0026reg; device has limitations, particularly in stabilizing the head. In the event of inadequate sedation, the patient may attempt to move their heads, thus necessitating manual immobilization. Additionally, the device may be insufficiently durable, thus precluding its repeated use.\u003c/p\u003e \u003cp\u003eThis study has several limitations. First, as a single-center retrospective study, the findings may not be generalizable to other settings. However, the inclusion of over 500 procedures involving the use of the Medo V-Fix\u0026reg; device strengthens the validity of the results. Second, the evaluation of body movement control was subjective and varied among examiners, which may have affected the accuracy of the comparisons.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIn conclusion, the use of the Medo V-Fix\u0026reg; body positioning device significantly enhances body movement control and reduces the need for additional sedatives, thereby improving procedural safety and efficiency. Notably, the use of the device reduced the incidence of very poor body movement control by 50%, substantially reducing the need for manual intervention during the procedure. These findings support the integration of body-positioning devices into standard ERCP practices to enhance patient outcomes.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003ch2\u003eDisclosures\u003c/h2\u003e \u003cp\u003eDr. Haruka Masuda, Dr. Tsutomu Nishida, Dr. Kengo Matsumoto, Dr. Dai Nakamatsu, Dr. Shiro Hayashi, and Dr. Masashi Yamamoto have no conflicts of interest or financial ties to disclose.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eAcknowledgments\u003c/h2\u003e \u003cp\u003eWe would like to express our gratitude to Dr. Kazuhide Iwasa, Dr. Hiroki Takiyama, Dr. Yuhiko Katanosaka, Dr. Asuka Watanabe, Dr. Naohiro Sakamoto, Dr. Satoru Okabe, Dr. Yoshifumi Fujii, Dr. Naoto Osugi, Dr. Aya Sugimoto, and Dr. Koji Fukui from the Department of Gastroenterology at Toyonaka Municipal Hospital for their support and assistance during this study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBuxbaum JL, Freeman M, Amateau SK, Chalhoub JM, Coelho-Prabhu N, Desai M, Elhanafi SE, Forbes N, Fujii-Lau LL, Kohli DR, Kwon RS, Machicado JD, Marya NB, Pawa S, Ruan WH, Sheth SG, Thiruvengadam NR, Thosani NC, Qumseya BJ (2023) American Society for Gastrointestinal Endoscopy guideline on post-ERCP pancreatitis prevention strategies: summary and recommendations. Gastrointest Endosc 97:153\u0026ndash;162\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOgawa T, Tomoda T, Kato H, Akimoto Y, Tanaka S, Okada H (2020) Propofol sedation with a target-controlled infusion pump in elderly patients undergoing ERCP. Gastrointest Endosc 92:301\u0026ndash;307\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCommittee ASP, Early DS, Lightdale JR, Vargo JJ 2nd, Acosta RD, Chandrasekhara V, Chathadi KV, Evans JA, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Muthusamy VR, Pasha SF, Saltzman JR, Shergill AK, Cash BD, DeWitt JM (2018) Guidelines for sedation and anesthesia in GI endoscopy. Gastrointest Endosc 87:327\u0026ndash;337\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTravis AC, Pievsky D, Saltzman JR (2012) Endoscopy in the elderly. Am J Gastroenterol 107:1495\u0026ndash;1501 quiz 1494, 1502\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLee S, Han JH, Lee HS, Kim KB, Lee IK, Cha EJ, Shin YD, Park N, Park SM (2015) Efficacy and safety of a patient-positioning device (EZ-FIX) for endoscopic retrograde cholangiopancreatography. World J Gastroenterol 21:5995\u0026ndash;6000\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHaytural C, Aydinli B, Demir B, Bozkurt E, Parlak E, Disibeyaz S, Sarac A, Ozgok A, Kazanci D (2015) Comparison of Propofol, Propofol-Remifentanil, and Propofol-Fentanyl Administrations with Each Other Used for the Sedation of Patients to Undergo ERCP. Biomed Res Int 2015:465465\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSugiarto A, Kapuangan C, Tantri AR, Chrisnata V (2020) Effectivity of benzydamine hydrochloride gargle to reduce propofol consumption in endoscopic retrograde cholangiopancreatography procedure: a randomized controlled trial. BMC Anesthesiol 20:123\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGotoda T, Akamatsu T, Abe S, Shimatani M, Nakai Y, Hatta W, Hosoe N, Miura Y, Miyahara R, Yamaguchi D, Yoshida N, Kawaguchi Y, Fukuda S, Isomoto H, Irisawa A, Iwao Y, Uraoka T, Yokota M, Nakayama T, Fujimoto K, Inoue H (2021) Guidelines for sedation in gastroenterological endoscopy (second edition). Dig Endosc 33:21\u0026ndash;53\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHayashi S, Nishida T, Kuriki S, Chang LS, Aochi K, Meren E, Sakamoto T, Tomita R, Higaki Y, Osugi N, Sugimoto A, Takahashi K, Mukai K, Matsumoto K, Nakamatsu D, Yamamoto M, Fukui K, Takenaka M, Hosono M, Inada M (2020) Radiation exposure dose of fluoroscopy-guided gastrointestinal procedures: A single-center retrospective study. Endosc Int Open 8:E1872\u0026ndash;E1877\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHayashi S, Nishida T, Matsubara T, Osugi N, Sugimoto A, Takahashi K, Mukai K, Nakamatsu D, Yamamoto M, Fukui K, Inada M (2018) Radiation exposure dose and influencing factors during endoscopic retrograde cholangiopancreatography. PLoS ONE 13:e0207539\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHayashi S, Takenaka M, Hosono M, Kogure H, Hasatani K, Suda T, Maruyama H, Matsunaga K, Ihara H, Yoshio T, Nagaike K, Yamada T, Yakushijin T, Takagi T, Tsumura H, Kurita A, Asai S, Ito Y, Kuwai T, Hori Y, Maetani I, Ikezawa K, Iwashita T, Matsumoto K, Fujisawa T, Nishida T (2022) Diagnostic Reference Levels for Fluoroscopy-guided Gastrointestinal Procedures in Japan from the REX-GI Study: A Nationwide Multicentre Prospective Observational Study. Lancet Reg Health West Pac 20:100376\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHayashi S, Nishida T, Osugi N, Yamaoka S, Sugimoto A, Mukai K, Nakamatsu D, Matsumoto K, Yamamoto M, Fukui K, Takenaka M, Hosono M, Inada M (2021) Time Trend of the Radiation Exposure Dose in Endoscopic Retrograde Cholangiopancreatography Over an 8-Year Period: A Single-Center Retrospective Study. Am J Gastroenterol 116:100\u0026ndash;105\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-5423780/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5423780/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Endoscopic retrograde cholangiopancreatography (ERCP) is a precise procedure requiring appropriate body movement control for procedural safety and efficiency. Sedatives are commonly used but pose risks, especially for elderly patients. This study evaluated the effectiveness of the Medo V-Fix device for controlling patient movement during ERCP.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: Of 1558 ERCP procedures performed between January 2021 and March 2024, 1,723 were analyzed after excluding cases with missing data. Patients were divided into two groups, the device group (n=697) and the nondevice group (n=831). The two groups were compared in terms of body movement control, additional sedative administration, and procedure discontinuation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: The baseline characteristics were similar between the groups. Body movement control was better with the device (good, 65.7%; poor, 24.0%; and very poor, 10.3%) than without it (good, 48.1%; poor, 30.7%; and very poor, 21.2%) (P\u0026lt;0.0001). The device reduced the need for manual assistance and additional doses of sedatives. Fewer patients in the device group required an additional dose of thiopental (9.5% vs. 15.6%, P=0.0003), and the dose was lower (4.5 mg vs. 6 mg, P=0.0015). There were no procedure discontinuations in the device group and 5 discontinuations in the nondevice group. Multivariate analysis revealed that device use and emergency procedures indicated good movement control. Propensity matching confirmed the association between devise use and better control (good: 64.9% vs. 49.1%, poor: 30.7% vs. 24.7% vs. 31.8%, and very poor: 10.4% vs. 19.1%, P\u0026lt;0.0001).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e: The Medo V-Fix device significantly improved body movement control and reduced the need for both additional doses of sedatives and manual intervention, suggesting its potential for improving procedural safety and efficiency.\u003c/p\u003e","manuscriptTitle":"The Effectiveness of a Body Positioning Device for Controlling Patient Movement and Additional Sedative Use during ERCP: A Retrospective Analysis","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-11-13 02:32:35","doi":"10.21203/rs.3.rs-5423780/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"d082b41e-238e-4a91-97d5-5c524cddbbbb","owner":[],"postedDate":"November 13th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":40047009,"name":"Gastroenterology \u0026 Hepatology"}],"tags":[],"updatedAt":"2024-11-13T02:32:35+00:00","versionOfRecord":[],"versionCreatedAt":"2024-11-13 02:32:35","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5423780","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5423780","identity":"rs-5423780","version":["v1"]},"buildId":"WrCJVZZCHTDjtuVLN7oU0","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}