Clinical Validation of Moni-Patch TM for Perioperative Core Temperature Monitoring: A Prospective Observational Study Comparing with Esophageal Temperature Measurements

Clinical Validation of Moni-Patch TM for Perioperative Core Temperature Monitoring: A Prospective Observational Study Comparing with Esophageal Temperature Measurements | 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 Clinical Validation of Moni-Patch TM for Perioperative Core Temperature Monitoring: A Prospective Observational Study Comparing with Esophageal Temperature Measurements Soichi Tanaka, Noriaki Nishihara, Shunsuke Tachibana, Michiaki Yamakage This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7418450/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 5 You are reading this latest preprint version Abstract Purpose Maintaining normothermia during surgery is essential for reducing perioperative complications. Although esophageal temperature monitoring is considered the gold standard for intraoperative core temperature assessment, it is invasive. Moni-Patch TM is a novel, noninvasive, wireless skin-surface sensor designed to estimate core temperature by measuring over the carotid artery. This study aimed to evaluate the clinical agreement between Moni-Patch TM , a novel noninvasive wireless temperature sensor, and esophageal temperature measurements during general anesthesia. Methods We conducted a prospective observational study in 40 adult patients undergoing non-cardiac surgery under general anesthesia lasting ≥120 minutes. Temperature measurements were recorded at one-minute intervals using both devices. Agreement was assessed using Bland-Altman analysis with random-effects modeling and Lin's concordance correlation coefficient (CCC). The proportion of measurements within ±0.5 °C of the reference value was calculated. Sensitivity and specificity for detecting hypothermia and hyperthermia were also evaluated. Results A total of 12,320 paired measurements were analyzed. Bland-Altman analysis demonstrated a small mean bias of 0.063 °C. The 95% limits of agreement ranged from -0.59 °C to 0.71 °C. Lin’s CCC was 0.90 (95% CI, 0.897-0.904). Overall, 88.8% of measurements were within ±0.5 °C of the esophageal reference. Moni-Patch demonstrated high sensitivity and specificity for detecting both hypothermia and hyperthermia. No device-related adverse events were observed. Conclusion Moni-Patch demonstrated clinically acceptable agreement with esophageal temperature measurements and may serve as a reliable noninvasive alternative for intraoperative core temperature monitoring. UMIN Clinical Trials Registry ID: UMIN000038589 Perioperative temperature management Core temperature monitoring Noninvasive thermometry Moni-Patch Esophageal temperature General anesthesia Figures Figure 1 Figure 2 Figure 3 Introduction Perioperative patients are at substantial risk of inadvertent hypothermia due to various factors, including anesthetic-induced redistribution of heat from the core to the periphery, exposure of body surfaces, and intraoperative blood loss [ 1 ]. Maintaining normothermia during the perioperative period is essential to prevent complications such as surgical site infections, increased blood loss, cardiac events, and delayed recovery from anesthesia [ 2 – 4 ]. Accurate monitoring of core body temperature is therefore a critical component of anesthetic management. Core temperature is typically measured at sites such as the pulmonary artery, distal esophagus, and nasopharynx. Although these methods provide reliable measurements, they are invasive and raise concerns regarding patient comfort and infection risk [ 5 , 6 ]. As a result, several noninvasive alternatives have been developed, including the Zero Heat Flux (ZHF)-based SpotOn™ system and the heat-flux compensated Temple Touch Pro™ [ 7 , 8 ]. However, their use may be limited or impractical in certain surgical environments due to interference with the sterile field or other monitoring equipment [ 9 ]. Moni-Patch™ (Murata Manufacturing Co., Ltd., Kyoto, Japan) is a noninvasive, wireless skin surface sensor designed to estimate core temperature by measuring skin temperature over the carotid artery. It operates using the corrected heat flux methodology and enables continuous, user-friendly monitoring [ 10 ]. Given the high blood flow and anatomical proximity to the aorta, temperature measurements at the carotid site have shown strong correlation with core temperature [ 11 , 12 ]. Unlike ZHF systems that require thermal equilibrium and prolonged warm-up periods, Moni-Patch™ offers faster stabilization and greater flexibility in sensor placement. These features may enhance clinical utility in diverse perioperative settings, especially where traditional probes are contraindicated or not feasible. However, despite its promising design, the accuracy of Moni-Patch™ in estimating core body temperature has not been extensively validated against standard esophageal thermometry. Therefore, we conducted a prospective observational study to compare the performance of Moni-Patch™ with esophageal temperature monitoring in adult surgical patients. Methods This prospective observational study was conducted at Sapporo Medical University Hospital (Sapporo, Japan) in accordance with the Declaration of Helsinki. Ethical approval was obtained from the Institutional Review Board of Sapporo Medical University Hospital (Approval No. 342 − 183) on October 10, 2019. The study was registered with the UMIN Clinical Trials Registry (UMIN000038589) on November 21, 2019. Written informed consent was obtained from all participants prior to enrollment. Participants From November 2019 to May 2024, 40 adult patients aged 20 to 80 years, with American Society of Anesthesiologists Physical Status (ASA-PS) I to III, scheduled for non-cardiac surgery under general anesthesia lasting at least 120 minutes, were enrolled. Exclusion criteria included fragile skin over the anterior neck, contraindications to esophageal temperature probe placement, and anticipated surgery duration of less than 120 minutes. Patients were also excluded if intraoperative events such as massive hemorrhage, significant anemia, or impaired oxygenation prevented study continuation. Monitoring and Temperature Measurement Standard ASA monitoring, including pulse oximetry, electrocardiography, noninvasive blood pressure, and ventilatory parameters, was applied. Anesthetic technique, ventilator settings, and fluid management were left to the discretion of the attending anesthesiologist. Before induction, Moni-Patch (T m ) was affixed to the right anterior neck and wirelessly connected via Bluetooth to its monitoring unit. The detailed description of the Moni-Patch™ is given in Online Resource 1. After induction of anesthesia, an esophageal temperature probe (T eso : Novatemp®; NOVAMED, Israel) was inserted into the distal esophagus and connected to the patient monitor. Temperature data from both devices were automatically recorded in the electronic anesthesia record. Data collection began 10 minutes after probe placement to allow sensor equilibration [ 13 ]. Paired temperature measurements were recorded at one-minute intervals until emergence from anesthesia. At the end of surgery, both devices were removed, and the Moni-Patch site was inspected for adverse effects such as erythema or pressure injury. Ambient operating room temperature was maintained between 22°C and 25°C. Perioperative thermal management was performed according to institutional guidelines using active warming and prewarmed intravenous fluids [ 14 ]. Active warming was provided using a forced-air warming system (3M™ Bair Hugger™ Model 775; 3M Company, St. Paul, MN, USA), ensuring that the Moni-patch was not directly exposed to the heat source. Intravenous fluids and blood products were warmed to 37°C with a fluid-warming device. Outcomes and Statistical Analysis The primary outcome was the level of agreement between Moni-Patch and esophageal temperature measurements. Agreement was assessed using Bland-Altman analysis with a random-effects model to account for repeated measures within subjects. The proportion of paired measurements within ± 0.5°C of the esophageal reference was calculated. Lin’s concordance correlation coefficient was also used to assess agreement. Secondary outcomes included the diagnostic performance of Moni-Patch in detecting hypothermia and hyperthermia. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated using standard definitions. Hypothermia and hyperthermia were defined as esophageal temperatures below 36°C and above 38°C, respectively. Device-related complications were recorded and compared between groups. All statistical analyses were performed using Prism version 10.4.2 (GraphPad Software, San Diego, CA, USA) and MedCalc® Statistical Software version 23.2.1 (MedCalc Software Ltd., Ostend, Belgium; https://www.medcalc.org ; 2021). A p-value of less than 0.05 was considered statistically significant. Given the lack of prior clinical validation data for Moni-Patch, a sample size of 40 patients was chosen based on the minimum recommended number for Bland-Altman agreement analysis, as outlined in the ASVCP guidelines [ 15 ]. Preliminary findings showed sufficient agreement between Moni-Patch and esophageal temperatures, and further enrollment was deemed unnecessary. Results A total of 43 patients aged 20 to 80 years were assessed for eligibility. Three were excluded due to technical issues with the reference temperature measurements. Data from 40 patients were included in the final analysis (Fig. 1 ). A total of 14,712 temperature measurements were collected, and after quality assessment, 12,320 paired data points were analyzed. Patient Characteristics Demographic and procedural data are summarized in Table 1 . The mean age of participants was 62 ± 13 years. Laparoscopic surgery was the most common procedure (32.5%). The median duration of anesthesia was 310 minutes (interquartile range [IQR], 249–392), and the median surgical duration was 233 minutes (IQR, 180–331). Thirty-five patients (87.5%) received active warming with forced-air systems. Table 1 Patient characteristics. Variables Value Data pairs, n 12320 Age (years) 62 (13) Male, n (%) 24 (60) Female, n (%) 16 (40) BMI (kg/m 2 ) 22.4 (9.8) Duration of anesthesia (min) 310 [249–392] Duration of surgery (min) 233 [180–331] ASA-PS Ⅰ 9 (22.5) Ⅱ 26 (65) Ⅲ 5 (12.5) Type of surgery Laparoscopic surgery (upper abdominal) 9 (22.5) Laparoscopic surgery (lower abdominal) 13 (32.5) Video-assisted thoracic surgery 3 (7.5) Laparotomy surgery 6 (15) Deep brain stimulation 5 (12.5) Extremity surgery 7 (17.5) Head and neck surgery 1 (2.5) Intraoperative active forced-air warming 35 (87.5) Continuous data are presented as means (standard deviation) or medians [IQR]; categorical data are presented as number of patients (%). Temperature Measurement Agreement Esophageal temperatures (T eso ) ranged from 33.9°C to 39.8°C, with a mean of 36.2 ± 0.76°C. Moni-Patch temperatures (T m ) ranged from 34.1°C to 38.4°C, with a mean of 36.3 ± 0.70°C. The mean difference between T m and T eso was 0.063°C (95% confidence interval [CI], 0.057–0.068), with a standard deviation (SD) of 0.33°C. Bland-Altman analysis demonstrated a small mean bias of 0.063°C and relatively narrow 95% limits of agreement (LOA). The upper LOA was 0.71°C (95% CI, 0.70–0.72), and the lower LOA was − 0.59°C (95% CI, -0.60 to -0.58) (Fig. 2 ). Lin’s concordance correlation coefficient was 0.90 (95% CI, 0.897–0.904) (Fig. 3 ). At identical time points, 88.8% of Moni-Patch and esophageal temperature measurements differed by less than ± 0.5°C (95% CI, 88.2–89.5%). Diagnostic Performance and Safety Table 2 presents the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the detection of hypothermia and hyperthermia. No complications or adverse events related to either device were observed. Table 2 Sensitivity, specificity, positive and negative predictive values for the detection of hypothermia and hyperthermia of temperature measured with the Moni-patch. Sensitivity (95% CI) Specificity (95% CI) PPV (95% CI) NPV (95% CI) Detection of hypothermia 0.66 (0.64 to 0.67) 0.93 (0.93 to 0.94) 0.84 (0.83 to 0.85) 0.83 (0.82 to 0.84) Detection of hypethermia 0.81 (0.75 to 0.85) 1.0 (1.0 to 1.0) 1.0 (0.98 to 1.0) 1.0 (1.0 to 1.0) PPV positive predictive value, NPV negative predictive value Discussion In this prospective observational study, we evaluated the accuracy of a novel noninvasive temperature monitoring system, the Moni-Patch, by comparing its performance with esophageal temperature measurements in adult patients undergoing general anesthesia. The results demonstrated a strong correlation between Moni-Patch and esophageal temperatures. Bland-Altman analysis revealed a small mean bias and narrow 95% limits of agreement, indicating clinically acceptable concordance across repeated measurements. The high proportion of readings within ± 0.5°C supports the use of Moni-Patch as a viable noninvasive alternative to standard invasive temperature monitoring, particularly when continuous monitoring is required. Previous studies indicate that carotid skin temperature may track core temperature trends but often lacks the precision required for intraoperative use [ 12 ]. In contrast, our findings suggest that Moni-Patch provides accurate estimates, likely due to the corrected heat flux method enabling stable measurement at high-perfusion sites. Several noninvasive systems share similar surface heat exchange principles. The 3M™ SpotOn™ (Bair Hugger™) uses the zero heat flux method at the forehead and has shown accuracy comparable to Moni-Patch [ 16 – 18 ], although a systematic review reported wide 95% limits of agreement (-0.93°C to + 0.98°C) across settings [ 19 ]. The Temple Touch Pro™ applies a heat-transfer principle at the temporal region, with reported bias of 0.09°C and 94% of measurements within ± 0.5°C of reference values [ 20 – 22 ]. Reliable detection of perioperative hypothermia and hyperthermia is essential for patient safety during prolonged or high-risk surgery [ 23 , 24 ]. In this study, Moni-Patch showed moderate sensitivity and high specificity for hypothermia, and excellent accuracy for hyperthermia, with perfect predictive values and no false classifications. Conventional noninvasive thermometers (oral, tympanic membrane, temporal artery) typically exhibit high specificity but poor sensitivity for fever [ 25 , 26 ]. In contrast, Moni-Patch achieved both high sensitivity and specificity for hyperthermia, supporting its reliability for perioperative fever detection. For hypothermia, forehead and temporal artery thermometry have demonstrated poor diagnostic performance [ 13 , 27 , 28 ]. Among common noninvasive sites, only tympanic membrane measurements have shown acceptable accuracy [ 29 ]. These findings suggest that Moni-Patch is a highly specific and clinically useful tool for identifying temperature extremes in the perioperative setting. It appears less susceptible to interference from environmental factors, surgical field constraints, or other devices. Its diagnostic accuracy makes it a promising option for continuous temperature monitoring in high-acuity settings such as intensive care units. While zero-heat-flux (ZHF) thermometers have higher initial costs than conventional intermittent devices, continuous core temperature monitoring can yield downstream savings by preventing hypothermia-related complications [ 17 ]. Direct cost comparisons between Moni-Patch and other systems are limited, but its wireless design, reusable components, and suitability for extended use in PACU, ICU, or outpatient care may confer economic advantages. Reduced nursing workload through continuous remote monitoring could further enhance cost-effectiveness [ 2 ]. ZHF devices, including Moni-Patch, show clinically acceptable agreement with invasive measurements under stable conditions but have notable limitations in perioperative and critical care settings. Adequate local perfusion is required to achieve thermal equilibrium; thus, peripheral vasoconstriction from hypothermia, low cardiac output, or vasopressor use may lead to core temperature underestimation [ 30 ]. Excess moisture or sweat at the sensor–skin interface can compromise insulation, reduce accuracy, and cause detachment—issues relevant in prolonged procedures or febrile patients. For optimal implementation, Moni-Patch should be applied to well-perfused sites with secure adhesion, and readings should be interpreted in the context of hemodynamic status and skin condition, particularly during rapid physiological changes. To our knowledge, this is the first perioperative study to evaluate a corrected heat flux thermometer over the carotid region against esophageal temperature. Accurate core temperature monitoring is critical in neuroanesthesia, trauma, and sepsis care. Moni-Patch™ demonstrated strong agreement with esophageal measurements and allows continuous tracking of thermal trends, whereas tympanic and forehead thermometers are more prone to environmental and operator variability [ 31 ]. In settings where temperature informs urgent decisions—such as antibiotic escalation or therapeutic hypothermia—Moni-Patch may offer superior accuracy. Its noninvasive, wearable design supports seamless use from the operating room to intensive care, adding value in the management of unstable patients. This study has limitations. First, it included only adults undergoing non-cardiac surgery, limiting generalizability to pediatric or critically ill populations. Second, although the sample size met requirements for Bland–Altman analysis, a larger cohort would improve precision and external validity. Third, intraoperative factors such as active warming, vasopressor use, or altered peripheral perfusion may influence skin-based measurements. ZHF sensors may also be affected by neck skin thickness, which warrants consideration in obese patients. Conclusion Moni-Patch demonstrated clinically acceptable agreement with esophageal temperature measurements and may serve as a practical, accurate, and noninvasive method for continuous core temperature monitoring in adult surgical patients. Further studies involving larger and more diverse populations are needed to validate these findings and expand its clinical applications. Declarations Funding This work was supported by Murata Manufacturing Co., Ltd. The company provided financial support but had no influence on the study design, data analysis, or manuscript preparation. Competing Interests The authors declare that they have no competing interests related to this work. All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by N.N. and S.T. The first draft of the manuscript was written by S.T. and S.Ta., and M.Y. commented on previous versions of the manuscript. All authors read and approved the final manuscript. Ethics Approval This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Institutional Review Board of Sapporo Medical University Hospital (Approval No. 342-183) on October 10, 2019. Consent to Participate Written informed consent was obtained from all individual participants included in the study. References Burger L, Fitzpatrick J. Prevention of inadvertent perioperative hypothermia. Br J Nurs. 2009;18:1114, 1116–9. https://doi.org/10.12968/bjon.2009.18.18.44553 . Madrid E, Urrútia G, Figuls MR, et al. Active body surface warming systems for preventing complications caused by inadvertent perioperative hypothermia in adults. Cochrane Database Syst Rev. 2016;4:CD009016. https://doi.org/10.1002/14651858.CD009016.pub2 . Frank SM, Fleisher LA, Breslow MJ, et al. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997;277(14):1127–34. Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. N Engl J Med. 1996;334(19):1209–15. Torossian A, Bräuer A, Höcker J, et al. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015;112(10):166–72. https://doi.org/10.3238/arztebl.2015.0166 . Hymczak H, Gołąb A, Mendrala K, et al. Core temperature measurement-principles of correct measurement, problems, and complications. Int J Environ Res Public Health. 2021;18(20):10606. https://doi.org/10.3390/ijerph182010606 . Sang BH, Lee C, Lee DY. Prospective comparative analysis of noninvasive body temperature monitoring using zero heat flux technology (SpotOn sensor) compared with esophageal temperature monitoring during pediatric surgery. PLoS ONE. 2022;17(8):e0272720. https://doi.org/10.1371/journal.pone.0272720 . Wang J, Liang H, Tian C, et al. Agreement of zero–heat–flux thermometry compared with infrared tympanic temperature monitoring in adults undergoing major surgery. Eur J Med Res. 2025;30:60. https://doi.org/10.1186/s40001-025-02317-9 . Sessler DI. Perioperative temperature monitoring. Anesthesiology. 2021;134:111–8. https://doi.org/10.1097/ALN.0000000000003481 . Murata Manufacturing Co., Ltd. Moni-Patch™ Temperature Sensor Package Insert, Kyoto. Japan: (2023) Murata Manufacturing Co., Ltd. https://medical.murata.com/-/media/medical/assets/pdf/products/moni-patch/moni-patch-file.ashx?la=ja-jp&cvid=20240423043111000000 Jay O, Molgat–Seon Y, Chou S, et al. Skin temperature over the carotid artery provides an accurate noninvasive estimation of core temperature in infants and young children during general anesthesia. Paediatr Anaesth. 2013;23:1109–16. https://doi.org/10.1111/pan.12262 . Selvaraj V, Gnanaprakasam PV. Evaluation of skin temperature over carotid artery for temperature monitoring in comparison to nasopharyngeal temperature in adults under general anesthesia. Anesth Essays Res. 2016;10:291–6. https://doi.org/10.4103/0259-1162.172722 . Bräuer B, Fazliu A, Brandes IF, et al. Evaluation of the Temple Touch Pro™ noninvasive core–temperature monitoring system in 100 adults under general anesthesia: a prospective comparison with esophageal temperature. J Clin Monit Comput. 2023;37:29–36. https://doi.org/10.1007/s10877-022-00851-z . National Institute for Health and Care Excellence (NICE). Hypothermia: prevention and management in adults having surgery. London: NICE; 2016. (Clinical guideline [CG65], updated 2016. https://www.nice.org.uk/guidance/cg65 . Loo CY, Cohn LA, Jensen AL, et al. ASVCP guidelines: Principles of quality assurance and standards for veterinary clinical pathology. Vet Clin Pathol. 2019;48:542–618. https://doi.org/10.1111/vcp.12810 . Chen A, Zhu J, Lin Q, et al. A comparative study of forehead temperature and core body temperature under varying ambient temperature conditions. Int J Environ Res Public Health. 2022;19:15883. https://doi.org/10.3390/ijerph192315883 . Eshraghi Y, Nasr V, Parra-Sanchez I, et al. An evaluation of a zero-heat-flux cutaneous thermometer in cardiac surgical patients. Anesth Analg. 2014;119:543–9. https://doi.org/10.1213/ANE.0000000000000319 . Iden T, Horn EP, Bein B, et al. Intraoperative temperature monitoring with zero heat flux technology (3M SpotOn sensor) in comparison with sublingual and nasopharyngeal temperature: an observational study. Eur J Anaesthesiol. 2015;32:387–91. https://doi.org/10.1097/EJA.0000000000000232 . Conway A, Bittner M, Phan D, et al. Accuracy and precision of zero-heat-flux temperature measurements with the 3M™ Bair Hugger™ Temperature Monitoring System: A systematic review and meta-analysis. J Clin Monit Comput. 2021;35:39–49. https://doi.org/10.1007/s10877-020-00543-6 . Nemeth M, Klose K, Asendorf T, et al. Evaluation of the noninvasive Temple Touch Pro temperature monitoring system compared with oesophageal temperature in paediatric anaesthesia (PETER PAN): A prospective observational study. Eur J Anaesthesiol. 2023;40(3):198–207. https://doi.org/10.1097/EJA.0000000000001796 . Fujii T, Takakura M, Taniguchi T, et al. Accuracy of non-invasive core temperature monitoring in infant and toddler patients: a prospective observational study. J Anesth. 2024;38:848–54. https://doi.org/10.1007/s00540-024-03404-7 . Evron S, Weissman A, Toivis V, et al. Evaluation of the Temple Touch Pro, a novel noninvasive core-temperature monitoring system. Anesth Analg. 2017;125:103–9. https://doi.org/10.1213/ANE.0000000000001695 . Munday J, Delaforce A, Heidke P, et al. Perioperative temperature monitoring for patient safety: A period prevalence study of five hospitals. Int J Nurs Stud. 2023;143:104508. https://doi.org/10.1016/j.ijnurstu.2023.104508 . Savaş IK, Bayhan Gİ. What is the difference between the different types of thermometers? Turk Arch Pediatr. 2025;60:78–83. https://doi.org/10.5152/TurkArchPediatr.2025.24240 . Bijur PE, Shah PD, Esses D. Temperature measurement in the adult emergency department: oral, tympanic membrane and temporal artery temperatures versus rectal temperature. Emerg Med J. 2016;33(12):843–7. https://doi.org/10.1136/emermed-2015-205122 . Allegaert K, Casteels K, van Gorp I, et al. Tympanic, infrared skin, and temporal artery scan thermometers compared with rectal measurement in children: a real-life assessment. Curr Ther Res Clin Exp. 2014;76:34–8. https://doi.org/10.1016/j.curtheres.2013.11.005 . Lawson L, Bridges EJ, Ballou I, et al. Accuracy and precision of noninvasive temperature measurement in adult intensive care patients. Am J Crit Care. 2007;16:485–96. https://doi.org/10.4037/ajcc2007.16.5.485 . Aykanat VM, Broadbent E, Peyton P. Reliability of alternative devices for postoperative patient temperature measurement: Two prospective, observational studies. Anaesthesia. 2021;76:514–9. https://doi.org/10.1111/anae.15248 . Stelfox HT, Straus SE, Ghali WA, et al. Temporal artery versus bladder thermometry during adult medical-surgical intensive care monitoring: an observational study. BMC Anesthesiol. 2010;10:13. https://doi.org/10.1186/1471-2253-10-13 . Sessler DI. (2016) Perioperative thermoregulation and heat balance. Lancet 25;387(10038):2655–2664. https://doi.org/10.1016/S0140-6736(15)00981-2 Erickson RS, Kirklin SK. Comparison of ear-based, bladder, oral, and axillary methods for core temperature measurement. Crit Care Med. 1993;21(10):1528–34. https://doi.org/10.1097/00003246-199310000-00022 . Additional Declarations No competing interests reported. Supplementary Files S1.docx Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 31 Aug, 2025 Reviewers invited by journal 29 Aug, 2025 Editor assigned by journal 21 Aug, 2025 Submission checks completed at journal 21 Aug, 2025 First submitted to journal 20 Aug, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-7418450","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":508540141,"identity":"2a89881a-8f94-4451-a968-c73ee69d8c90","order_by":0,"name":"Soichi Tanaka","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA6UlEQVRIiWNgGAWjYFACxgZmBgMGBnn2xsYHQC4PH7FaJAx7DjcbgLSwEWMPMxBLMNxIb5MA8QhqkW9vbvxcUMBQx9iQ2Fb5NcdOho2B+eGjG3i0GJw52Cw9A+gwdoaDbbdltyUDHcZmbJyDT4tEYhszD1ALY2Nj223JbcxALTxs0vi0yM+AamE4zNhWLLmtnrAWhhswLccY2xg/bjtMWAvYLzwGEpIbexibpRm3HedhYybgF/n29oefef7Y8MvLP3/48ee2ant+9uaHj/E6DALAMcLAzAMmCStHAMYfpKgeBaNgFIyCEQMA5nQ/31F3tx8AAAAASUVORK5CYII=","orcid":"","institution":"Sapporo Medical University School of Medicine","correspondingAuthor":true,"prefix":"","firstName":"Soichi","middleName":"","lastName":"Tanaka","suffix":""},{"id":508540142,"identity":"c4a49ef5-fc4b-4798-aae3-6aa59f4b30cf","order_by":1,"name":"Noriaki Nishihara","email":"","orcid":"","institution":"Sapporo Medical University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Noriaki","middleName":"","lastName":"Nishihara","suffix":""},{"id":508540143,"identity":"66f07827-d7a0-4c9a-969a-f80230775f59","order_by":2,"name":"Shunsuke Tachibana","email":"","orcid":"","institution":"Sapporo Medical University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Shunsuke","middleName":"","lastName":"Tachibana","suffix":""},{"id":508540144,"identity":"82eeb11d-3b67-4ea1-b566-586755548f52","order_by":3,"name":"Michiaki Yamakage","email":"","orcid":"","institution":"Sapporo Medical University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Michiaki","middleName":"","lastName":"Yamakage","suffix":""}],"badges":[],"createdAt":"2025-08-20 14:23:29","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7418450/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7418450/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":90894505,"identity":"11808a5c-8f76-449f-94a9-a8ec445295f4","added_by":"auto","created_at":"2025-09-09 11:30:23","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":22324,"visible":true,"origin":"","legend":"\u003cp\u003ePatient flow diagram. A total of 43 patients were assessed for eligibility\u003c/p\u003e\n\u003cp\u003eThree were excluded due to technical issues with the reference temperature measurement. The remaining 40 patients were included in the final analysis.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7418450/v1/c2dba51d99d59eb3e1e149ae.png"},{"id":90894509,"identity":"6f8b9bed-9602-4c5b-a16b-2256883a14f0","added_by":"auto","created_at":"2025-09-09 11:30:23","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":70280,"visible":true,"origin":"","legend":"\u003cp\u003eBland-Altman plot with multiple temperature measurements 40 patients with 12320 measurement pairs of Moni-patch temperature (T\u003csub\u003em\u003c/sub\u003e) and esophageal probe (T\u003csub\u003eeso\u003c/sub\u003e). The solid line indicates the mean bias of 0.063 °C, and dashed lines indicate the 95% limits of agreement (LOA). Upper LOA: +0.71 °C, lower LOA: -0.59 °C.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7418450/v1/2609c88fd7757435fd1678cb.png"},{"id":90894507,"identity":"1ed20929-317b-44da-b483-0a30ea458fb8","added_by":"auto","created_at":"2025-09-09 11:30:23","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":66342,"visible":true,"origin":"","legend":"\u003cp\u003eCorrelation estimated between Moni-patch temperature and esophageal probe (T\u003csub\u003eeso\u003c/sub\u003e)\u003c/p\u003e\n\u003cp\u003eCorrelation between Moni-Patch™ temperature (T\u003csub\u003em\u003c/sub\u003e) and esophageal temperature (T\u003csub\u003eeso\u003c/sub\u003e). Lin’s concordance correlation coefficient was 0.90.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7418450/v1/8e3c768ce543986933718ddd.png"},{"id":90897619,"identity":"9dafc71d-2321-408b-9031-d9c8d754bb47","added_by":"auto","created_at":"2025-09-09 11:46:28","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":588028,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7418450/v1/b36a7fbb-dc1a-4746-b0ec-7817a69bb6b0.pdf"},{"id":90894514,"identity":"519de8c9-48a2-4866-abb9-763185a04b48","added_by":"auto","created_at":"2025-09-09 11:30:24","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":418174,"visible":true,"origin":"","legend":"","description":"","filename":"S1.docx","url":"https://assets-eu.researchsquare.com/files/rs-7418450/v1/199a5f5e60c21b6e1141d1f9.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Clinical Validation of Moni-Patch TM for Perioperative Core Temperature Monitoring: A Prospective Observational Study Comparing with Esophageal Temperature Measurements","fulltext":[{"header":"Introduction","content":"\u003cp\u003ePerioperative patients are at substantial risk of inadvertent hypothermia due to various factors, including anesthetic-induced redistribution of heat from the core to the periphery, exposure of body surfaces, and intraoperative blood loss [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Maintaining normothermia during the perioperative period is essential to prevent complications such as surgical site infections, increased blood loss, cardiac events, and delayed recovery from anesthesia [\u003cspan additionalcitationids=\"CR3\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Accurate monitoring of core body temperature is therefore a critical component of anesthetic management.\u003c/p\u003e\u003cp\u003eCore temperature is typically measured at sites such as the pulmonary artery, distal esophagus, and nasopharynx. Although these methods provide reliable measurements, they are invasive and raise concerns regarding patient comfort and infection risk [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. As a result, several noninvasive alternatives have been developed, including the Zero Heat Flux (ZHF)-based SpotOn\u0026trade; system and the heat-flux compensated Temple Touch Pro\u0026trade; [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. However, their use may be limited or impractical in certain surgical environments due to interference with the sterile field or other monitoring equipment [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eMoni-Patch\u0026trade; (Murata Manufacturing Co., Ltd., Kyoto, Japan) is a noninvasive, wireless skin surface sensor designed to estimate core temperature by measuring skin temperature over the carotid artery. It operates using the corrected heat flux methodology and enables continuous, user-friendly monitoring [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Given the high blood flow and anatomical proximity to the aorta, temperature measurements at the carotid site have shown strong correlation with core temperature [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Unlike ZHF systems that require thermal equilibrium and prolonged warm-up periods, Moni-Patch\u0026trade; offers faster stabilization and greater flexibility in sensor placement. These features may enhance clinical utility in diverse perioperative settings, especially where traditional probes are contraindicated or not feasible. However, despite its promising design, the accuracy of Moni-Patch\u0026trade; in estimating core body temperature has not been extensively validated against standard esophageal thermometry. Therefore, we conducted a prospective observational study to compare the performance of Moni-Patch\u0026trade; with esophageal temperature monitoring in adult surgical patients.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e This prospective observational study was conducted at Sapporo Medical University Hospital (Sapporo, Japan) in accordance with the Declaration of Helsinki. Ethical approval was obtained from the Institutional Review Board of Sapporo Medical University Hospital (Approval No. 342\u0026thinsp;\u0026minus;\u0026thinsp;183) on October 10, 2019. The study was registered with the UMIN Clinical Trials Registry (UMIN000038589) on November 21, 2019. Written informed consent was obtained from all participants prior to enrollment.\u003c/p\u003e\u003cp\u003eParticipants\u003c/p\u003e\u003cp\u003eFrom November 2019 to May 2024, 40 adult patients aged 20 to 80 years, with American Society of Anesthesiologists Physical Status (ASA-PS) I to III, scheduled for non-cardiac surgery under general anesthesia lasting at least 120 minutes, were enrolled. Exclusion criteria included fragile skin over the anterior neck, contraindications to esophageal temperature probe placement, and anticipated surgery duration of less than 120 minutes. Patients were also excluded if intraoperative events such as massive hemorrhage, significant anemia, or impaired oxygenation prevented study continuation.\u003c/p\u003e\u003cp\u003eMonitoring and Temperature Measurement\u003c/p\u003e\u003cp\u003eStandard ASA monitoring, including pulse oximetry, electrocardiography, noninvasive blood pressure, and ventilatory parameters, was applied. Anesthetic technique, ventilator settings, and fluid management were left to the discretion of the attending anesthesiologist.\u003c/p\u003e\u003cp\u003eBefore induction, Moni-Patch (T\u003csub\u003em\u003c/sub\u003e) was affixed to the right anterior neck and wirelessly connected via Bluetooth to its monitoring unit. The detailed description of the Moni-Patch\u0026trade; is given in Online Resource 1. After induction of anesthesia, an esophageal temperature probe (T\u003csub\u003eeso\u003c/sub\u003e: Novatemp\u0026reg;; NOVAMED, Israel) was inserted into the distal esophagus and connected to the patient monitor. Temperature data from both devices were automatically recorded in the electronic anesthesia record. Data collection began 10 minutes after probe placement to allow sensor equilibration [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Paired temperature measurements were recorded at one-minute intervals until emergence from anesthesia. At the end of surgery, both devices were removed, and the Moni-Patch site was inspected for adverse effects such as erythema or pressure injury.\u003c/p\u003e\u003cp\u003eAmbient operating room temperature was maintained between 22\u0026deg;C and 25\u0026deg;C. Perioperative thermal management was performed according to institutional guidelines using active warming and prewarmed intravenous fluids [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Active warming was provided using a forced-air warming system (3M\u0026trade; Bair Hugger\u0026trade; Model 775; 3M Company, St. Paul, MN, USA), ensuring that the Moni-patch was not directly exposed to the heat source. Intravenous fluids and blood products were warmed to 37\u0026deg;C with a fluid-warming device.\u003c/p\u003e\u003cp\u003eOutcomes and Statistical Analysis\u003c/p\u003e\u003cp\u003eThe primary outcome was the level of agreement between Moni-Patch and esophageal temperature measurements. Agreement was assessed using Bland-Altman analysis with a random-effects model to account for repeated measures within subjects. The proportion of paired measurements within \u0026plusmn;\u0026thinsp;0.5\u0026deg;C of the esophageal reference was calculated. Lin\u0026rsquo;s concordance correlation coefficient was also used to assess agreement.\u003c/p\u003e\u003cp\u003eSecondary outcomes included the diagnostic performance of Moni-Patch in detecting hypothermia and hyperthermia. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated using standard definitions. Hypothermia and hyperthermia were defined as esophageal temperatures below 36\u0026deg;C and above 38\u0026deg;C, respectively. Device-related complications were recorded and compared between groups.\u003c/p\u003e\u003cp\u003eAll statistical analyses were performed using Prism version 10.4.2 (GraphPad Software, San Diego, CA, USA) and MedCalc\u0026reg; Statistical Software version 23.2.1 (MedCalc Software Ltd., Ostend, Belgium; \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.medcalc.org\u003c/span\u003e\u003cspan address=\"https://www.medcalc.org\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e; 2021). A p-value of less than 0.05 was considered statistically significant.\u003c/p\u003e\u003cp\u003eGiven the lack of prior clinical validation data for Moni-Patch, a sample size of 40 patients was chosen based on the minimum recommended number for Bland-Altman agreement analysis, as outlined in the ASVCP guidelines [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Preliminary findings showed sufficient agreement between Moni-Patch and esophageal temperatures, and further enrollment was deemed unnecessary.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 43 patients aged 20 to 80 years were assessed for eligibility. Three were excluded due to technical issues with the reference temperature measurements. Data from 40 patients were included in the final analysis (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). A total of 14,712 temperature measurements were collected, and after quality assessment, 12,320 paired data points were analyzed.\u003c/p\u003e\n\u003cp\u003ePatient Characteristics\u003c/p\u003e\n\u003cp\u003eDemographic and procedural data are summarized in Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e. The mean age of participants was 62\u0026thinsp;\u0026plusmn;\u0026thinsp;13 years. Laparoscopic surgery was the most common procedure (32.5%). The median duration of anesthesia was 310 minutes (interquartile range [IQR], 249\u0026ndash;392), and the median surgical duration was 233 minutes (IQR, 180\u0026ndash;331). Thirty-five patients (87.5%) received active warming with forced-air systems.\u003c/p\u003e\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\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\n \u003cp\u003eVariables\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eValue\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\u003eData pairs, n\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e12320\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAge (years)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e62 (13)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMale, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e24 (60)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFemale, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e16 (40)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBMI (kg/m\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e22.4 (9.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDuration of anesthesia (min)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e310 [249\u0026ndash;392]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDuration of surgery (min)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e233 [180\u0026ndash;331]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eASA-PS\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\u003eⅠ\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e9 (22.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eⅡ\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e26 (65)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eⅢ\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (12.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eType of surgery\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\u003eLaparoscopic surgery (upper abdominal)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e9 (22.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eLaparoscopic surgery (lower abdominal)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e13 (32.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVideo-assisted thoracic surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3 (7.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eLaparotomy surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6 (15)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDeep brain stimulation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (12.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eExtremity surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7 (17.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eHead and neck surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (2.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eIntraoperative active forced-air warming\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e35 (87.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003c/p\u003e\n\u003cp\u003eContinuous data are presented as means (standard deviation) or medians [IQR]; categorical data are presented as number of patients (%).\u003c/p\u003e\n\u003cp\u003eTemperature Measurement Agreement\u003c/p\u003e\n\u003cp\u003eEsophageal temperatures (T\u003csub\u003eeso\u003c/sub\u003e) ranged from 33.9\u0026deg;C to 39.8\u0026deg;C, with a mean of 36.2\u0026thinsp;\u0026plusmn;\u0026thinsp;0.76\u0026deg;C. Moni-Patch temperatures (T\u003csub\u003em\u003c/sub\u003e) ranged from 34.1\u0026deg;C to 38.4\u0026deg;C, with a mean of 36.3\u0026thinsp;\u0026plusmn;\u0026thinsp;0.70\u0026deg;C. The mean difference between T\u003csub\u003em\u003c/sub\u003e and T\u003csub\u003eeso\u003c/sub\u003e was 0.063\u0026deg;C (95% confidence interval [CI], 0.057\u0026ndash;0.068), with a standard deviation (SD) of 0.33\u0026deg;C.\u003c/p\u003e\n\u003cp\u003eBland-Altman analysis demonstrated a small mean bias of 0.063\u0026deg;C and relatively narrow 95% limits of agreement (LOA). The upper LOA was 0.71\u0026deg;C (95% CI, 0.70\u0026ndash;0.72), and the lower LOA was \u0026minus;\u0026thinsp;0.59\u0026deg;C (95% CI, -0.60 to -0.58) (Fig. \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e). Lin\u0026rsquo;s concordance correlation coefficient was 0.90 (95% CI, 0.897\u0026ndash;0.904) (Fig. \u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eAt identical time points, 88.8% of Moni-Patch and esophageal temperature measurements differed by less than \u0026plusmn;\u0026thinsp;0.5\u0026deg;C (95% CI, 88.2\u0026ndash;89.5%).\u003c/p\u003e\n\u003cp\u003eDiagnostic Performance and Safety\u003c/p\u003e\n\u003cp\u003eTable \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003epresents the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the detection of hypothermia and hyperthermia. No complications or adverse events related to either device were observed.\u003c/p\u003e\n\u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eSensitivity, specificity, positive and negative predictive values for the detection of hypothermia and hyperthermia of temperature measured with the Moni-patch.\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\u003eSensitivity (95% CI)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eSpecificity (95% CI)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ePPV (95% CI)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eNPV (95% CI)\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\u003eDetection of hypothermia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.66 (0.64 to 0.67)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.93 (0.93 to 0.94)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.84 (0.83 to 0.85)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.83 (0.82 to 0.84)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDetection of hypethermia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.81 (0.75 to 0.85)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.0 (1.0 to 1.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.0 (0.98 to 1.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.0 (1.0 to 1.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003ePPV positive predictive value, NPV negative predictive value\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn this prospective observational study, we evaluated the accuracy of a novel noninvasive temperature monitoring system, the Moni-Patch, by comparing its performance with esophageal temperature measurements in adult patients undergoing general anesthesia. The results demonstrated a strong correlation between Moni-Patch and esophageal temperatures. Bland-Altman analysis revealed a small mean bias and narrow 95% limits of agreement, indicating clinically acceptable concordance across repeated measurements. The high proportion of readings within \u0026plusmn;\u0026thinsp;0.5\u0026deg;C supports the use of Moni-Patch as a viable noninvasive alternative to standard invasive temperature monitoring, particularly when continuous monitoring is required.\u003c/p\u003e\u003cp\u003ePrevious studies indicate that carotid skin temperature may track core temperature trends but often lacks the precision required for intraoperative use [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. In contrast, our findings suggest that Moni-Patch provides accurate estimates, likely due to the corrected heat flux method enabling stable measurement at high-perfusion sites.\u003c/p\u003e\u003cp\u003eSeveral noninvasive systems share similar surface heat exchange principles. The 3M\u0026trade; SpotOn\u0026trade; (Bair Hugger\u0026trade;) uses the zero heat flux method at the forehead and has shown accuracy comparable to Moni-Patch [\u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e], although a systematic review reported wide 95% limits of agreement (-0.93\u0026deg;C to +\u0026thinsp;0.98\u0026deg;C) across settings [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The Temple Touch Pro\u0026trade; applies a heat-transfer principle at the temporal region, with reported bias of 0.09\u0026deg;C and 94% of measurements within \u0026plusmn;\u0026thinsp;0.5\u0026deg;C of reference values [\u003cspan additionalcitationids=\"CR21\" citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eReliable detection of perioperative hypothermia and hyperthermia is essential for patient safety during prolonged or high-risk surgery [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. In this study, Moni-Patch showed moderate sensitivity and high specificity for hypothermia, and excellent accuracy for hyperthermia, with perfect predictive values and no false classifications. Conventional noninvasive thermometers (oral, tympanic membrane, temporal artery) typically exhibit high specificity but poor sensitivity for fever [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. In contrast, Moni-Patch achieved both high sensitivity and specificity for hyperthermia, supporting its reliability for perioperative fever detection. For hypothermia, forehead and temporal artery thermometry have demonstrated poor diagnostic performance [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Among common noninvasive sites, only tympanic membrane measurements have shown acceptable accuracy [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThese findings suggest that Moni-Patch is a highly specific and clinically useful tool for identifying temperature extremes in the perioperative setting. It appears less susceptible to interference from environmental factors, surgical field constraints, or other devices. Its diagnostic accuracy makes it a promising option for continuous temperature monitoring in high-acuity settings such as intensive care units.\u003c/p\u003e\u003cp\u003eWhile zero-heat-flux (ZHF) thermometers have higher initial costs than conventional intermittent devices, continuous core temperature monitoring can yield downstream savings by preventing hypothermia-related complications [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Direct cost comparisons between Moni-Patch and other systems are limited, but its wireless design, reusable components, and suitability for extended use in PACU, ICU, or outpatient care may confer economic advantages. Reduced nursing workload through continuous remote monitoring could further enhance cost-effectiveness [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eZHF devices, including Moni-Patch, show clinically acceptable agreement with invasive measurements under stable conditions but have notable limitations in perioperative and critical care settings. Adequate local perfusion is required to achieve thermal equilibrium; thus, peripheral vasoconstriction from hypothermia, low cardiac output, or vasopressor use may lead to core temperature underestimation [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. Excess moisture or sweat at the sensor\u0026ndash;skin interface can compromise insulation, reduce accuracy, and cause detachment\u0026mdash;issues relevant in prolonged procedures or febrile patients. For optimal implementation, Moni-Patch should be applied to well-perfused sites with secure adhesion, and readings should be interpreted in the context of hemodynamic status and skin condition, particularly during rapid physiological changes.\u003c/p\u003e\u003cp\u003eTo our knowledge, this is the first perioperative study to evaluate a corrected heat flux thermometer over the carotid region against esophageal temperature. Accurate core temperature monitoring is critical in neuroanesthesia, trauma, and sepsis care. Moni-Patch\u0026trade; demonstrated strong agreement with esophageal measurements and allows continuous tracking of thermal trends, whereas tympanic and forehead thermometers are more prone to environmental and operator variability [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. In settings where temperature informs urgent decisions\u0026mdash;such as antibiotic escalation or therapeutic hypothermia\u0026mdash;Moni-Patch may offer superior accuracy. Its noninvasive, wearable design supports seamless use from the operating room to intensive care, adding value in the management of unstable patients.\u003c/p\u003e\u003cp\u003eThis study has limitations. First, it included only adults undergoing non-cardiac surgery, limiting generalizability to pediatric or critically ill populations. Second, although the sample size met requirements for Bland\u0026ndash;Altman analysis, a larger cohort would improve precision and external validity. Third, intraoperative factors such as active warming, vasopressor use, or altered peripheral perfusion may influence skin-based measurements. ZHF sensors may also be affected by neck skin thickness, which warrants consideration in obese patients.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eMoni-Patch demonstrated clinically acceptable agreement with esophageal temperature measurements and may serve as a practical, accurate, and noninvasive method for continuous core temperature monitoring in adult surgical patients. Further studies involving larger and more diverse populations are needed to validate these findings and expand its clinical applications.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eFunding\u003c/p\u003e\n\u003cp\u003eThis work was supported by Murata Manufacturing Co., Ltd. The company provided financial support but had no influence on the study design, data analysis, or manuscript preparation.\u003c/p\u003e\n\u003cp\u003eCompeting Interests\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests related to this work.\u003c/p\u003e\n\u003cp\u003eAll authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by N.N. and S.T. The first draft of the manuscript was written by S.T. and S.Ta., and M.Y. commented on previous versions of the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003eEthics Approval\u003c/p\u003e\n\u003cp\u003eThis study was performed in line with the principles of the Declaration of Helsinki. Approval was\u003c/p\u003e\n\u003cp\u003egranted by the Institutional Review Board of Sapporo Medical University Hospital (Approval No. 342-183) on October 10, 2019.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConsent to Participate\u003c/p\u003e\n\u003cp\u003eWritten informed consent was obtained from all individual participants included in the study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBurger L, Fitzpatrick J. Prevention of inadvertent perioperative hypothermia. Br J Nurs. 2009;18:1114, 1116\u0026ndash;9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.12968/bjon.2009.18.18.44553\u003c/span\u003e\u003cspan address=\"10.12968/bjon.2009.18.18.44553\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMadrid E, Urr\u0026uacute;tia G, Figuls MR, et al. Active body surface warming systems for preventing complications caused by inadvertent perioperative hypothermia in adults. Cochrane Database Syst Rev. 2016;4:CD009016. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1002/14651858.CD009016.pub2\u003c/span\u003e\u003cspan address=\"10.1002/14651858.CD009016.pub2\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eFrank SM, Fleisher LA, Breslow MJ, et al. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997;277(14):1127\u0026ndash;34.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. N Engl J Med. 1996;334(19):1209\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eTorossian A, Br\u0026auml;uer A, H\u0026ouml;cker J, et al. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015;112(10):166\u0026ndash;72. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.3238/arztebl.2015.0166\u003c/span\u003e\u003cspan address=\"10.3238/arztebl.2015.0166\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHymczak H, Gołąb A, Mendrala K, et al. Core temperature measurement-principles of correct measurement, problems, and complications. Int J Environ Res Public Health. 2021;18(20):10606. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.3390/ijerph182010606\u003c/span\u003e\u003cspan address=\"10.3390/ijerph182010606\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSang BH, Lee C, Lee DY. Prospective comparative analysis of noninvasive body temperature monitoring using zero heat flux technology (SpotOn sensor) compared with esophageal temperature monitoring during pediatric surgery. PLoS ONE. 2022;17(8):e0272720. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1371/journal.pone.0272720\u003c/span\u003e\u003cspan address=\"10.1371/journal.pone.0272720\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWang J, Liang H, Tian C, et al. Agreement of zero\u0026ndash;heat\u0026ndash;flux thermometry compared with infrared tympanic temperature monitoring in adults undergoing major surgery. Eur J Med Res. 2025;30:60. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/s40001-025-02317-9\u003c/span\u003e\u003cspan address=\"10.1186/s40001-025-02317-9\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSessler DI. Perioperative temperature monitoring. Anesthesiology. 2021;134:111\u0026ndash;8. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1097/ALN.0000000000003481\u003c/span\u003e\u003cspan address=\"10.1097/ALN.0000000000003481\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMurata Manufacturing Co., Ltd. Moni-Patch\u0026trade; Temperature Sensor Package Insert, Kyoto. Japan: (2023) Murata Manufacturing Co., Ltd. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://medical.murata.com/-/media/medical/assets/pdf/products/moni-patch/moni-patch-file.ashx?la=ja-jp\u0026amp;cvid=20240423043111000000\u003c/span\u003e\u003cspan address=\"https://medical.murata.com/-/media/medical/assets/pdf/products/moni-patch/moni-patch-file.ashx?la=ja-jp\u0026amp;cvid=20240423043111000000\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eJay O, Molgat\u0026ndash;Seon Y, Chou S, et al. Skin temperature over the carotid artery provides an accurate noninvasive estimation of core temperature in infants and young children during general anesthesia. Paediatr Anaesth. 2013;23:1109\u0026ndash;16. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1111/pan.12262\u003c/span\u003e\u003cspan address=\"10.1111/pan.12262\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSelvaraj V, Gnanaprakasam PV. Evaluation of skin temperature over carotid artery for temperature monitoring in comparison to nasopharyngeal temperature in adults under general anesthesia. Anesth Essays Res. 2016;10:291\u0026ndash;6. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.4103/0259-1162.172722\u003c/span\u003e\u003cspan address=\"10.4103/0259-1162.172722\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBr\u0026auml;uer B, Fazliu A, Brandes IF, et al. Evaluation of the Temple Touch Pro\u0026trade; noninvasive core\u0026ndash;temperature monitoring system in 100 adults under general anesthesia: a prospective comparison with esophageal temperature. J Clin Monit Comput. 2023;37:29\u0026ndash;36. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s10877-022-00851-z\u003c/span\u003e\u003cspan address=\"10.1007/s10877-022-00851-z\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNational Institute for Health and Care Excellence (NICE). Hypothermia: prevention and management in adults having surgery. London: NICE; 2016. (Clinical guideline [CG65], updated 2016. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.nice.org.uk/guidance/cg65\u003c/span\u003e\u003cspan address=\"https://www.nice.org.uk/guidance/cg65\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLoo CY, Cohn LA, Jensen AL, et al. ASVCP guidelines: Principles of quality assurance and standards for veterinary clinical pathology. Vet Clin Pathol. 2019;48:542\u0026ndash;618. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1111/vcp.12810\u003c/span\u003e\u003cspan address=\"10.1111/vcp.12810\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eChen A, Zhu J, Lin Q, et al. A comparative study of forehead temperature and core body temperature under varying ambient temperature conditions. Int J Environ Res Public Health. 2022;19:15883. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.3390/ijerph192315883\u003c/span\u003e\u003cspan address=\"10.3390/ijerph192315883\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eEshraghi Y, Nasr V, Parra-Sanchez I, et al. An evaluation of a zero-heat-flux cutaneous thermometer in cardiac surgical patients. Anesth Analg. 2014;119:543\u0026ndash;9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1213/ANE.0000000000000319\u003c/span\u003e\u003cspan address=\"10.1213/ANE.0000000000000319\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eIden T, Horn EP, Bein B, et al. Intraoperative temperature monitoring with zero heat flux technology (3M SpotOn sensor) in comparison with sublingual and nasopharyngeal temperature: an observational study. Eur J Anaesthesiol. 2015;32:387\u0026ndash;91. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1097/EJA.0000000000000232\u003c/span\u003e\u003cspan address=\"10.1097/EJA.0000000000000232\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eConway A, Bittner M, Phan D, et al. Accuracy and precision of zero-heat-flux temperature measurements with the 3M\u0026trade; Bair Hugger\u0026trade; Temperature Monitoring System: A systematic review and meta-analysis. J Clin Monit Comput. 2021;35:39\u0026ndash;49. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s10877-020-00543-6\u003c/span\u003e\u003cspan address=\"10.1007/s10877-020-00543-6\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNemeth M, Klose K, Asendorf T, et al. Evaluation of the noninvasive Temple Touch Pro temperature monitoring system compared with oesophageal temperature in paediatric anaesthesia (PETER PAN): A prospective observational study. Eur J Anaesthesiol. 2023;40(3):198\u0026ndash;207. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1097/EJA.0000000000001796\u003c/span\u003e\u003cspan address=\"10.1097/EJA.0000000000001796\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eFujii T, Takakura M, Taniguchi T, et al. Accuracy of non-invasive core temperature monitoring in infant and toddler patients: a prospective observational study. J Anesth. 2024;38:848\u0026ndash;54. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s00540-024-03404-7\u003c/span\u003e\u003cspan address=\"10.1007/s00540-024-03404-7\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eEvron S, Weissman A, Toivis V, et al. Evaluation of the Temple Touch Pro, a novel noninvasive core-temperature monitoring system. Anesth Analg. 2017;125:103\u0026ndash;9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1213/ANE.0000000000001695\u003c/span\u003e\u003cspan address=\"10.1213/ANE.0000000000001695\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMunday J, Delaforce A, Heidke P, et al. Perioperative temperature monitoring for patient safety: A period prevalence study of five hospitals. Int J Nurs Stud. 2023;143:104508. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.ijnurstu.2023.104508\u003c/span\u003e\u003cspan address=\"10.1016/j.ijnurstu.2023.104508\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSavaş IK, Bayhan Gİ. What is the difference between the different types of thermometers? Turk Arch Pediatr. 2025;60:78\u0026ndash;83. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.5152/TurkArchPediatr.2025.24240\u003c/span\u003e\u003cspan address=\"10.5152/TurkArchPediatr.2025.24240\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBijur PE, Shah PD, Esses D. Temperature measurement in the adult emergency department: oral, tympanic membrane and temporal artery temperatures versus rectal temperature. Emerg Med J. 2016;33(12):843\u0026ndash;7. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1136/emermed-2015-205122\u003c/span\u003e\u003cspan address=\"10.1136/emermed-2015-205122\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAllegaert K, Casteels K, van Gorp I, et al. Tympanic, infrared skin, and temporal artery scan thermometers compared with rectal measurement in children: a real-life assessment. Curr Ther Res Clin Exp. 2014;76:34\u0026ndash;8. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.curtheres.2013.11.005\u003c/span\u003e\u003cspan address=\"10.1016/j.curtheres.2013.11.005\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLawson L, Bridges EJ, Ballou I, et al. Accuracy and precision of noninvasive temperature measurement in adult intensive care patients. Am J Crit Care. 2007;16:485\u0026ndash;96. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.4037/ajcc2007.16.5.485\u003c/span\u003e\u003cspan address=\"10.4037/ajcc2007.16.5.485\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAykanat VM, Broadbent E, Peyton P. Reliability of alternative devices for postoperative patient temperature measurement: Two prospective, observational studies. Anaesthesia. 2021;76:514\u0026ndash;9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1111/anae.15248\u003c/span\u003e\u003cspan address=\"10.1111/anae.15248\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eStelfox HT, Straus SE, Ghali WA, et al. Temporal artery versus bladder thermometry during adult medical-surgical intensive care monitoring: an observational study. BMC Anesthesiol. 2010;10:13. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/1471-2253-10-13\u003c/span\u003e\u003cspan address=\"10.1186/1471-2253-10-13\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSessler DI. (2016) Perioperative thermoregulation and heat balance. Lancet 25;387(10038):2655\u0026ndash;2664. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/S0140-6736(15)00981-2\u003c/span\u003e\u003cspan address=\"10.1016/S0140-6736(15)00981-2\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eErickson RS, Kirklin SK. Comparison of ear-based, bladder, oral, and axillary methods for core temperature measurement. Crit Care Med. 1993;21(10):1528\u0026ndash;34. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1097/00003246-199310000-00022\u003c/span\u003e\u003cspan address=\"10.1097/00003246-199310000-00022\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"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":"journal-of-clinical-monitoring-and-computing","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [Journal of Clinical Monitoring and Computing](https://www.springer.com/journal/10877)","snPcode":"10877","submissionUrl":"https://submission.nature.com/new-submission/10877/3","title":"Journal of Clinical Monitoring and Computing","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Perioperative temperature management, Core temperature monitoring, Noninvasive thermometry, Moni-Patch, Esophageal temperature, General anesthesia","lastPublishedDoi":"10.21203/rs.3.rs-7418450/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7418450/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMaintaining normothermia during surgery is essential for reducing perioperative complications. Although esophageal temperature monitoring is considered the gold standard for intraoperative core temperature assessment, it is invasive. Moni-Patch\u003csup\u003eTM\u003c/sup\u003e is a novel, noninvasive, wireless skin-surface sensor designed to estimate core temperature by measuring over the carotid artery. This study aimed to evaluate the clinical agreement between Moni-Patch\u003csup\u003eTM\u003c/sup\u003e, a novel noninvasive wireless temperature sensor, and esophageal temperature measurements during general anesthesia.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe conducted a prospective observational study in 40 adult patients undergoing non-cardiac surgery under general anesthesia lasting ≥120 minutes. Temperature measurements were recorded at one-minute intervals using both devices. Agreement was assessed using Bland-Altman analysis with random-effects modeling and Lin's concordance correlation coefficient (CCC). The proportion of measurements within ±0.5 °C of the reference value was calculated. Sensitivity and specificity for detecting hypothermia and hyperthermia were also evaluated.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA total of 12,320 paired measurements were analyzed. Bland-Altman analysis demonstrated a small mean bias of 0.063 °C. The 95% limits of agreement ranged from -0.59 °C to 0.71 °C. Lin’s CCC was 0.90 (95% CI, 0.897-0.904). Overall, 88.8% of measurements were within ±0.5 °C of the esophageal reference. Moni-Patch demonstrated high sensitivity and specificity for detecting both hypothermia and hyperthermia. No device-related adverse events were observed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMoni-Patch demonstrated clinically acceptable agreement with esophageal temperature measurements and may serve as a reliable noninvasive alternative for intraoperative core temperature monitoring.\u003c/p\u003e\n\u003cp\u003eUMIN Clinical Trials Registry ID: UMIN000038589\u003c/p\u003e","manuscriptTitle":"Clinical Validation of Moni-Patch TM for Perioperative Core Temperature Monitoring: A Prospective Observational Study Comparing with Esophageal Temperature Measurements","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-09 11:30:19","doi":"10.21203/rs.3.rs-7418450/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"239046793819071060579418938189155234538","date":"2025-08-31T14:26:53+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-08-29T10:44:04+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-08-21T08:17:10+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-08-21T08:13:18+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Clinical Monitoring and Computing","date":"2025-08-20T14:19:03+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-clinical-monitoring-and-computing","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [Journal of Clinical Monitoring and Computing](https://www.springer.com/journal/10877)","snPcode":"10877","submissionUrl":"https://submission.nature.com/new-submission/10877/3","title":"Journal of Clinical Monitoring and Computing","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"227cd2cc-5b56-4fab-bdf2-93a83f9d488b","owner":[],"postedDate":"September 9th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-09-09T11:30:19+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-09 11:30:19","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7418450","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7418450","identity":"rs-7418450","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}