Handheld Versus Conventional Ultrasound for Assessing Carotid Artery in Routine Volunteers

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Handheld ultrasound demonstrated moderate to excellent agreement with conventional ultrasound for assessing carotid intima-media thickness and hemodynamic parameters in routine volunteers.

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Abstract

Objective: The study aimed to estimate the feasibility and accuracy of carotid intima-media thickness (CIMT) and hemodynamic parameters measurement in a handheld ultrasound device. Methods: : Utilizing an ex vivo pig carotid artery sample, CIMT was measured with a handheld ultrasound and compared with histopathology. Then we performed a carotid ultrasound on 25 volunteers using a handheld ultrasound device and a conventional ultrasound system. After a week, these volunteers were scanned again by the same observer. Assessments of the max IMT, mean IMT and hemodynamic parameters (PSV, EDV, PI, RI, S/D, ACCEL, AT, TAMEAN) were compared. Intraclass correlation coefficient (ICC) was used to assess inter-device agreement. Repeatability and correlation of mean IMT were analyzed by Bland–Altman Plots and linear correlation analysis. Results: : The mean IMT measured from the common carotid artery by handheld ultrasound showed good agreement (ICC=0.79) with conventional ultrasound. Furthermore, we obtained good repeatability and a consistent trend in the mean value of IMT before and after (r = 0.680, P < 0.01). In addition, the max IMT and the hemodynamic parameters (PSV, EDV, S/D, ACCEL, TAMEAN) showed moderate agreement (ICC=0.73, 0.52, 0.58, 0.70, 0.61, 0.51, respectively). The PI, RI and HR values were excellent agreement with conventional ultrasound (ICC=0.80, 0.84, 0.94). Conclusion: About the basic assessment of carotid, the images and parameters obtained using handheld ultrasound showed a moderate to excellent agreement with conventional ultrasound. The handheld ultrasonic devices can be widely used as a diagnostic tool for carotid artery structure and hemodynamics examination.
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Handheld Versus Conventional Ultrasound for Assessing Carotid Artery in Routine Volunteers | 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 Handheld Versus Conventional Ultrasound for Assessing Carotid Artery in Routine Volunteers Lin Jin, Jianxiong Chen, Lanyue Tong, Cuiqin Shen, Lianfang Du, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-1172637/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 Objective: The study aimed to estimate the feasibility and accuracy of carotid intima-media thickness (CIMT) and hemodynamic parameters measurement in a handheld ultrasound device. Methods: Utilizing an ex vivo pig carotid artery sample, CIMT was measured with a handheld ultrasound and compared with histopathology. Then we performed a carotid ultrasound on 25 volunteers using a handheld ultrasound device and a conventional ultrasound system. After a week, these volunteers were scanned again by the same observer. Assessments of the max IMT, mean IMT and hemodynamic parameters (PSV, EDV, PI, RI, S/D, ACCEL, AT, TAMEAN) were compared. Intraclass correlation coefficient (ICC) was used to assess inter-device agreement. Repeatability and correlation of mean IMT were analyzed by Bland–Altman Plots and linear correlation analysis. Results: The mean IMT measured from the common carotid artery by handheld ultrasound showed good agreement (ICC=0.79) with conventional ultrasound. Furthermore, we obtained good repeatability and a consistent trend in the mean value of IMT before and after (r = 0.680, P < 0.01). In addition, the max IMT and the hemodynamic parameters (PSV, EDV, S/D, ACCEL, TAMEAN) showed moderate agreement (ICC=0.73, 0.52, 0.58, 0.70, 0.61, 0.51, respectively). The PI, RI and HR values were excellent agreement with conventional ultrasound (ICC=0.80, 0.84, 0.94). Conclusion: About the basic assessment of carotid, the images and parameters obtained using handheld ultrasound showed a moderate to excellent agreement with conventional ultrasound. The handheld ultrasonic devices can be widely used as a diagnostic tool for carotid artery structure and hemodynamics examination. Nuclear Medicine & Medical Imaging Handheld ultrasound scanner Carotid artery Carotid intima-media thickness Ultrasound Figures Figure 1 Figure 2 Figure 3 Figure 4 Background Cardiovascular disease is the leading cause of death all over the world [ 1 ] . The root cause of cardiovascular and cerebrovascular events is atherosclerosis (AS), a chronic, inflammatory disease characterized by plaque formation on the intimal surface of the artery [ 2 ] . As the main clinical cause of stroke, carotid atherosclerosis is considered to be directly related to treatment effect, prognosis and recurrence, and may be an independent predictor of important adverse cardiac events [ 3 ] . Many studies revealed that carotid ultrasound could further evaluate and predict the risk of cardiovascular and cerebrovascular diseases by measuring carotid intima-media thickness (CIMT) [ 4 – 6 ] . The increased CIMT reflects the early stages of AS and cardiovascular risk. Recently, with its perspective, availability and portability, handheld ultrasound equipment is expected to become the second "Stethoscope" for general practitioners' outvolunteer, ward, site and family follow-up. This study investigated the feasibility and repeatability of a handheld ultrasound device in assessing CIMT and carotid hemodynamic parameters measurements compared with a conventional ultrasound device representative of this class of devices. Materials And Methods Tissue mimicking ultrasound phantom The ultrasound phantom used KS107BD (L) system (Institute of acoustics, Academy of Sciences, China). These phantoms were filled with ultrasonically tissue-mimicking materials (TM materials). In TM materials, speed of sound was 1540±10m/s, and acoustic attenuations were 0.70 ± 0.05dB/cm/MHz (23±3). Phantoms contained monofilament nylon targets and simulated tumor, cyst and stone. The longitudinal resolution and the axial resolution at different depths (2cm, 3cm, 4cm and 5cm, respectively) were measured by handheld ultrasound (STORK, China) and conventional ultrasound (Insight 37CT, SASET, China). The measurements were repeated 4 times, and took the average value. Ex Vivo carotid Phantom One freshly excised pig carotid was acquired from a local butcher shop. An acoustic absorber was placed on the bottom layer of the mold, and 0.9% normal saline was poured into the mold that contained the carotid sample, which was suspended by using a stitching thread, as shown in Figure 1 . A handheld device (STORK, China) equipped with a 4-12MHz linear probe was used. We used the automatic detection of IMT ultrasound technique for measuring IMT on our model by five times. The operator was blinded to the actual size of each model. Pathological Examination Hematoxylin and eosin (HE) staining: The pig carotid was sealed in 10% formalin solution and embedded in paraffin, which was then cross-sectioned for a transverse section of tissues of about 3µm in thickness. The section was then HE stained to observe IMT. The level of IMT in each slice was measured by Leica Cyclone software. We randomly selected five slices, measured each slice three times, and took the average value of IMT. Study population This study enrolled 25 volunteers (at Jiading Branch of Shanghai First People's Hospital, Shanghai, China). These volunteers underwent a scan using both the handheld ultrasound and a conventional ultrasound and repeated the scan after a week. One junior sonographer (with more than 3 years of experience in diagnostic ultrasound) performed all the exams. The order of the second visit was arranged by random. The observer was unaware of volunteers’ clinical information or status. Furthermore, each volunteer who underwent examination with the handheld ultrasound was performed after informed consent. Clinical investigations were performed according to the Declaration of Helsinki. Each participant signed the informed consent form for this study. This study protocol was approved by the medical ethics committee of Shanghai General Hospital (2019KY009-4) and registered on the official website of China Clinical Trial Registration Center (ChiCTR2000035937). Ultrasound examinations The volunteers underwent the examination in a supine position and breathed calmly. The enrolled volunteers underwent carotid ultrasound scans by the handheld ultrasound device (STORK, China) equipped with a 4-12MHz linear probe and a conventional ultrasound device (LOGIC P9, GE Healthcare) with a 3-12MHz linear probe. The IMT of the common carotid artery was measured at 1.5cm proximal to the carotid bifurcation. The max IMT, mean IMT were measured on the far wall along the common carotid artery and analyzed by internal automatic software. The length of the automatic sampling frame is about 15mm; the measurement of the CIMT was obtained using a micrometer-scale value. The CIMT and the hemodynamic parameters were measured in longitudinal planes. In addition, hemodynamic parameters, i.e., peak systolic velocity (PSV), end diastolic velocity (EDV), artery systolic-diastolic ratio (S/D=PSV/EDV), resistive index (RI= (PSV–EDV)/PSV), mean flow velocity (MFV), pulsatility index (PI= (PSV–EDV)/MFV), acceleration time (AT), blood flow acceleration (ACCEL), time averaged mean velocity (TAMEAN) of carotid arteries were acquired and recorded using the Doppler ultrasound technique. The values of hemodynamic parameters were measured and calculated with a mean value obtained in 3 continuous cardiac cycles (Figure 2 ). Statistical analysis SPSS 19.0 (IBM, Armonk, NY, USA) statistical analysis software was used. The continuous data were expressed as mean ± SD, and compared using a paired sample t-test. Non-normally distributed data were analyzed by Wilcoxon signed-rank test. Intraclass correlation coefficient (ICC) was used to assess inter-device agreement. The Bland-Altman plot and linear correlation analysis were used to assess repeatability and correlation of mean IMT. P <0.05 represented that the difference was statistically significant. Results 1.Tissue mimicking ultrasound phantom Targets at four different depths were evaluated in this study. There were no difference in the longitudinal resolution and the axial resolution by using handheld ultrasound and conventional ultrasound (Table 1 ). Table 1 Comparisons of conventional and handheld ultrasounds values in ultrasound phantoms (x ¯± s) Item Conventional ultrasounds Handheld ultrasounds t/Z value p value Longitudinal resolution (cm) 2cm 1.01±0.02 1.01±0.03 -0.111 a 0.919 a 3cm 0.99±0.02 0.99±0.01 1.567 a 0.215 a 4cm 1.02±0.02 1.01±0.03 0.000 b 1.000 b 5cm 1.01±0.02 1.00±0.02 -2.449 a 0.092 a Axial resolution (cm) 2cm 4.15±0.10 4.20±0.00 -1.000 b 0.317 b 3cm 4.10±0.14 4.20±0.08 1.000 a 0.391 a 4cm 4.03±0.15 4.10±0.14 1.000 a 0.391 a 5cm 4.08±0.17 4.05±0.13 -0.264 a 0.809 a a Paired t -test; b Wilcoxon signed-rank test 2.Ex Vivo Experiments Findings The IMT for the handheld ultrasound was 0.60 ± 0.03mm, and that for the HE was 0.57±0.01mm. The difference of IMT were not statistically significant ( P ༞0.05). The images were shown in Figure 3 . Volunteer Population We examined 25 volunteers (2 males and 23 females) and repeated the scan after a week. Therefore, 47 ultrasound examinations were performed and 3 ultrasound examinations were lost. Loss of consented volunteers was due to withdrawn consent or time constraints. The volunteers ranged in age from 22 to 50 years, mean age was 35.20 ± 8.68 years. 3.Measurements of CCA using handheld and conventional ultrasound To assess whether the carotid structure and hemodynamic parameters could be accurately carried out with the handheld ultrasound device, we compared the values of max IMT, mean IMT and hemodynamic parameters measurements from the handheld ultrasound with those from the conventional ultrasound. The comparisons of values between the handheld and conventional ultrasound were shown in Table 2 . The mean value of mean IMT was increased in handheld ultrasound group when compared with the conventional ultrasound group (0.50±0.07mm vs. 0.46±0.07mm, <0.001). However, the measurements had a good ICC of 0.79 for the mean IMT [95% confidence interval (CI): 0.66, 0.88]. The detailed analysis was shown in Table 3 . Table 2 Changes and comparisons of conventional and handheld ultrasounds values (x¯±s) (n=47) Item Conventional ultrasounds Handheld ultrasounds t/Z value p value Max IMT (mm) 0.54±0.08 0.51±0.07 -2.950 b 0.003 b Mean IMT (mm) 0.46±0.07 0.50±0.07 -4.495 b <0.001 b PSV (cm/s) 78.31±10.37 76.65±12.52 0.868 a 0.390 a EDV (cm/s) 25.2±3.45 21.89±4.54 4.402 b <0.001 b PI 1.34±0.22 1.52±0.30 -5.374 b <0.001 b RI 0.67±0.05 0.71±0.05 -5.377 b <0.001 b S/D 3.14±0.47 3.61±0.8 -5.519 b <0.001 b ACCEL (cm/s 2 ) 699.65±218.64 622.85±142.28 2.701 a 0.010 a AT (s) 0.08±0.02 0.09±0.01 -4.148 b <0.001 b TAMEAN (cm/s) 24.7±3.58 23.91±4.36 1.186 a 0.242 a HR (bpm) 72.87±8.18 74.4±8.82 -2. 571 a 0.013 a IMT: Intima-media thickness; PSV: Peak systolic velocity; EDV: End diastolic velocity; PI: Pulsatility index; RI: Resistive index; S/D: Systolic-diastolic ratio; ACCEL: Blood flow acceleration; AT: Acceleration time; TAMEAN: Time averaged mean velocity; HR: Heart rate a Paired t -test; b Wilcoxon signed-rank test Table 3 ICC analysis for conventional ultrasounds vs handheld ultrasounds (n=47) Item ICC (95% CI) p value Max intima-media thickness (mm) 0.73 (0.56-0.84) <0.001 Mean intima-media thickness (mm) 0.79 (0.66-0.88) <0.001 Peak systolic velocity (cm/s) 0.52 (0.13-0.73) 0.008 End diastolic velocity (cm/s) 0.58 (0.25-0.77) 0.002 Pulsatility index 0.80 (0.65-0.89) <0.001 Resistive index 0.84 (0.72-0.91) <0.001 Systolic-diastolic ratio 0.70 (0.47-0.84) <0.001 Blood flow acceleration (cm/s 2 ) 0.61 (0.31-0.78) 0.001 Acceleration time (s) 0.29 (-0.28-0.60) 0.129 Time averaged mean velocity (cm/s) 0.51 (0.13-0.73) 0.008 Heart rate (bpm) 0.94 (0.89-0.97) <0.001 4.Agreement and reproducibility of the handheld ultrasound To determine the reproducibility of mean IMT using a handheld ultrasound, the operator performed scans and measurements on the volunteers after a week. Bland-Altman analysis showed that the mean and standard deviation of the difference in the mean IMT measurements of handheld ultrasounds before and after were (0.015 ±0.057), and the mean and standard deviation of the difference in the mean IMT measurements of conventional ultrasounds before and after were (-0.004 ±0.046). The two measurements showed a consistent trend between the differential and mean values (Fig. 4 a and c). The repeatability test showed the handheld ultrasounds measurements of mean IMT before and after were correlated ( r = 0.680, P < 0.01), and the linear regression equation was y=0.117+0.739x . The conventional ultrasounds measurements of mean IMT before and after were highly correlated ( r = 0.789, P < 0.01), and the linear regression equation was y=0.040+0.922x . These values correspond to good reproducibility for this handheld ultrasound. The detailed analysis was shown in Figure 4 b and d. Discussion This observational study assessed the diagnostic feasibility of carotid artery structure and hemodynamic parameters using a handheld ultrasound. The main finding of this study was: The handheld ultrasound scans that focused on the basic assessment of carotid and hemodynamic parameters showed a moderate to good correlation with conventional ultrasound images. AS is a chronic inflammatory disease caused by a variety of etiologies and risk factors, which can affect many blood vessels in the whole body. The development of progressive vascular AS is the cause of most cardiovascular diseases (CVD) [ 7 ] . In the early stage of carotid atherosclerosis, a small amount of lipid will deposit on the intima, increasing CIMT. Previous studies have shown that the CIMT is an important indicator of arteriosclerosis and independent predictors of cardiovascular events [ 8 ] . Usually, the ultrasound scan is the most widely used method for CCA with its simplicity, non-invasion and excellent reproducibility, and utilized to evaluate the artery hemodynamic status and the measurement of the CIMT. Handheld ultrasound is a small portable device and is a rapidly evolving technology with significant challenges and opportunities. At present, it is mainly used in the preliminary screening of diseases in an emergency, operating room and community chronic disease management [ 9 ] . The examination items include various examinations of the heart, carotid artery, liver, kidney, thyroid and other organs. It has gradually become one of the important examination instruments for volunteers with cardiovascular diseases [ 10 , 11 ] . Of course, concerns about the limited size of handheld ultrasound devices degrades the imaging quality, which reduces the diagnostic reliability have been raised [ 12 , 13 ] . In addition, operator dependence, including high inter-and intra-operator variability, is crucial in using a handheld ultrasound device [ 14 , 15 ] . In our study, the results showed the differences in CIMT and hemodynamic parameters value between handheld ultrasound and conventional ultrasound. The reasons for these errors in our study may relate to the differences in quality between the handheld and conventional ultrasound images and the lower blood flow sensitivity compared to conventional ultrasound. The variability of Doppler-derived carotid hemodynamic measures has many sources, such as a small diversity in the insonation angle may result in a large velocity diversity [ 16 , 17 ] . In addition, ultrasound protocols to measure CIMT may vary in the selections of the carotid segments, angles, and walls of the carotid artery measured [ 18 ] ; this partially increase random differences in making outline and measurement of CIMT. However, in this study, the results showed the good agreement for the measurements between the handheld ultrasound and conventional ultrasound imaging studies. Although the values in this study between handheld ultrasound and conventional ultrasound are significant difference, our results suggested that the differences of values could be accepted within the clinical range. Our findings of handheld ultrasound are consistent with those in previously published studies. Jang et al. noted excellent agreement and repeatability between wireless handheld ultrasound and standard ultrasound in max-CIMT measurement [ 19 ] . Prinz et al. found that handheld echocardiographic devices showed a moderate to perfect correlation with standard echocardiography [ 20 ] . Notably, in our study, the reproducibility and consistency in assessing mean IMT using a handheld ultrasound device are good. These results suggested that the handheld ultrasound is effective as a screening tool for the identification of carotid artery structure and hemodynamic parameters disorders in clinical practice. Certainly, the differences could be reduced and reversed by successful image acquisition and assessment with improved intelligent analysis metabolism. Thus, this puts forward higher requirements in accuracy and sensitivity for handheld ultrasound equipment. However, this technique can provide a more helpful tool for screening in carotid artery disease or imaging biomarkers for CVD and cardiovascular risk. The use of handheld ultrasound can realize the preliminary judgment of ultrasonic image abnormalities in settings such as the primary care office or the emergency department, which may provide more cost-effective and time-efficient than traditional ultrasound. It is believed that with the development of science and technology, the detection of the carotid artery by handheld ultrasound will be more convenient, objective and accurate. Limitations In this study, we only scanned the carotid structure and hemodynamic parameters with high-frequency linear probes using handheld ultrasound; therefore, we cannot comment on the use of handheld ultrasound in other superficial organs’ examinations with linear probes, such as thyroid, breast, or with other types of probes. In addition, experiments in vitro and volunteers under more complicated conditions, such as CCA plaques were not tested. These image quality and parameters comparison with conventional ultrasound should be examined in the future. Conclusions Concerning primary assessment of carotid, the images obtained using handheld ultrasonic devices showed a moderate to good correlation with a conventional ultrasound system. The handheld ultrasound device can be used as a screening and follow-up tool to determine or exclude carotid artery abnormalities before the application of conventional ultrasound, and has the potential to be widely used as a diagnostic tool for carotid artery structure and hemodynamics examination, and it will bring more convenience to clinical work and better serve volunteers. Abbreviations CIMT: carotid intima-media thickness Declarations Acknowledgements We thank all of the patients involved in this study. Authors’ contributions ZJL conceived the study and revised the manuscript. JXC designed and performed the experiments. LJ performed the data analyses and drafted the manuscript. CQS and LYT are involved in ultrasound examination and diagnosis. LFD analyzed and interpreted data. All authors read and approved the final manuscript. Funding: This research was funded by Natural Science Foundation of Shanghai (21ZR1451400), Shanghai Jiading District Health and Family Planning Commission Fund (2021-KY-10) and Shanghai Songjiang District Science and Technology Project (18sjkjgg72, 18sjkjgg53). Ethics approval and consent to participate This study protocol was approved by the medical ethics committee of Shanghai General Hospital (2019KY009-4) and registered on the official website of China Clinical Trial Registration Center (ChiCTR2000035937). Consent for publication Written informed consent was obtained from all the patients for publication of this manuscript and any accompanying images. Availability of data and materials The datasets used in the manuscript are available from the corresponding author upon reasonable request. Competing interests: The authors declare that there is no conflict of interest with any financial organization or corporation or individual that can inappropriately influence this work. 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Li","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA7UlEQVRIie3QPWrDMBiA4U8I1EVYq4PBvYKDwVMO85lCujimEAjZYiho7drcIhDIrNKhi+Ku6pZcIV68NRJkyCQ3W6B6QYOEHvQDEArdYREAAi5/VwL4ZUkNEObIQVMcNTcQIEdJMVN/JkIdoJSszr/3n6cfCWlkkHQv3lOUfUvL54Wpp8lMQj4ySJN3HyGNJYuY7AwvqCXlxiCj3Eeo+zGWke2bzjtLVsOEOSKx3ECVuYthNki4I1rlsamKpGrj8VofXxMfEUIj6ZcqFe5i1WLyGH09fXQ+AsCf+6tZbAdpvADgQQ1sCIVCoX/fGbLDSIAt9LJIAAAAAElFTkSuQmCC","orcid":"","institution":"Shanghai General Hospital, Shanghai Jiaotong University School of Medicine","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Zhaojun","middleName":"","lastName":"Li","suffix":""}],"badges":[],"createdAt":"2021-12-15 06:44:10","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-1172637/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-1172637/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":16697341,"identity":"a9026684-6b8a-477b-8033-79b3e028c02c","added_by":"auto","created_at":"2021-12-22 18:31:33","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":492199,"visible":true,"origin":"","legend":"\u003cp\u003eAn ex vivo carotid (a), the data acquisition method using handheld ultrasound scanner (b), and pathological examination (c).\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-1172637/v1/4a5d7459e2895ee8cebac677.png"},{"id":16697343,"identity":"68c3191a-0ca4-4c37-987b-f7ac290d1915","added_by":"auto","created_at":"2021-12-22 18:31:33","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":338577,"visible":true,"origin":"","legend":"\u003cp\u003eThe handheld ultrasound image system, showing the measurement of CIMT and hemodynamic indexes with linear probe by the handheld ultrasound\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-1172637/v1/cc251242e48c12a16f0db6a5.png"},{"id":16697340,"identity":"204f80b7-2593-4e7e-9ef2-7616e8b7bfb1","added_by":"auto","created_at":"2021-12-22 18:31:33","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":486783,"visible":true,"origin":"","legend":"\u003cp\u003eIMT of pig carotid detected by handheld ultrasound (a) and hematoxylin and eosin (b). scale bar shows 400 μm (×40).\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-1172637/v1/226138f6e7ffa88db882cd5f.png"},{"id":16697342,"identity":"44e9df43-9804-4416-ac50-a5ac76d4cb51","added_by":"auto","created_at":"2021-12-22 18:31:33","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":262619,"visible":true,"origin":"","legend":"\u003cp\u003eRepeatability was analyzed by Bland–Altman Plots (a and c) and linear correlation analysis (b and d). The results showed a consistent trend in the difference value and the mean value of IMT before and after.\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-1172637/v1/5ef5de1aa06d771cfd80a2dd.png"},{"id":19298428,"identity":"4c3bed99-8175-4f1c-91e9-4ee044870d1c","added_by":"auto","created_at":"2022-03-16 16:14:16","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1991936,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-1172637/v1/49534cc5-e1e0-4896-819f-074e4d2f390b.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eHandheld Versus Conventional Ultrasound for Assessing Carotid Artery in Routine Volunteers\u003c/p\u003e","fulltext":[{"header":"Background","content":"\u003cp\u003eCardiovascular disease is the leading cause of death all over the world \u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/sup\u003e. The root cause of cardiovascular and cerebrovascular events is atherosclerosis (AS), a chronic, inflammatory disease characterized by plaque formation on the intimal surface of the artery \u003csup\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/sup\u003e. As the main clinical cause of stroke, carotid atherosclerosis is considered to be directly related to treatment effect, prognosis and recurrence, and may be an independent predictor of important adverse cardiac events \u003csup\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e. Many studies revealed that carotid ultrasound could further evaluate and predict the risk of cardiovascular and cerebrovascular diseases by measuring carotid intima-media thickness (CIMT) \u003csup\u003e[\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e. The increased CIMT reflects the early stages of AS and cardiovascular risk. Recently, with its perspective, availability and portability, handheld ultrasound equipment is expected to become the second \"Stethoscope\" for general practitioners' outvolunteer, ward, site and family follow-up. This study investigated the feasibility and repeatability of a handheld ultrasound device in assessing CIMT and carotid hemodynamic parameters measurements compared with a conventional ultrasound device representative of this class of devices.\u003c/p\u003e"},{"header":"Materials And Methods","content":"\u003ch2\u003eTissue mimicking ultrasound phantom\u003c/h2\u003e\n\u003cp\u003eThe ultrasound phantom used KS107BD (L) system (Institute of acoustics, Academy of Sciences, China). These phantoms were filled with ultrasonically tissue-mimicking materials (TM materials). In TM materials, speed of sound was 1540\u0026plusmn;10m/s, and acoustic attenuations were 0.70 \u0026plusmn; 0.05dB/cm/MHz (23\u0026plusmn;3). Phantoms contained monofilament nylon targets and simulated tumor, cyst and stone. The longitudinal resolution and the axial resolution at different depths (2cm, 3cm, 4cm and 5cm, respectively) were measured by handheld ultrasound (STORK, China) and conventional ultrasound (Insight 37CT, SASET, China). The measurements were repeated 4 times, and took the average value.\u003c/p\u003e\n\u003ch2\u003eEx Vivo carotid Phantom\u003c/h2\u003e\n\u003cp\u003eOne freshly excised pig carotid was acquired from a local butcher shop. An acoustic absorber was placed on the bottom layer of the mold, and 0.9% normal saline was poured into the mold that contained the carotid sample, which was suspended by using a stitching thread, as shown in Figure \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e. A handheld device (STORK, China) equipped with a 4-12MHz linear probe was used. We used the automatic detection of IMT ultrasound technique for measuring IMT on our model by five times. The operator was blinded to the actual size of each model.\u003c/p\u003e\n\u003ch2\u003ePathological Examination\u003c/h2\u003e\n\u003cp\u003eHematoxylin and eosin (HE) staining: The pig carotid was sealed in 10% formalin solution and embedded in paraffin, which was then cross-sectioned for a transverse section of tissues of about 3\u0026micro;m in thickness. The section was then HE stained to observe IMT. The level of IMT in each slice was measured by Leica Cyclone software. We randomly selected five slices, measured each slice three times, and took the average value of IMT.\u003c/p\u003e\n\u003ch2\u003eStudy population\u003c/h2\u003e\n\u003cp\u003eThis study enrolled 25 volunteers (at Jiading Branch of Shanghai First People\u0026apos;s Hospital, Shanghai, China). These volunteers underwent a scan using both the handheld ultrasound and a conventional ultrasound and repeated the scan after a week. One junior sonographer (with more than 3 years of experience in diagnostic ultrasound) performed all the exams. The order of the second visit was arranged by random. The observer was unaware of volunteers\u0026rsquo; clinical information or status. Furthermore, each volunteer who underwent examination with the handheld ultrasound was performed after informed consent. Clinical investigations were performed according to the Declaration of Helsinki. Each participant signed the informed consent form for this study. This study protocol was approved by the medical ethics committee of Shanghai General Hospital (2019KY009-4) and registered on the official website of China Clinical Trial Registration Center (ChiCTR2000035937).\u003c/p\u003e\n\u003ch2\u003eUltrasound examinations\u003c/h2\u003e\n\u003cp\u003eThe volunteers underwent the examination in a supine position and breathed calmly. The enrolled volunteers underwent carotid ultrasound scans by the handheld ultrasound device (STORK, China) equipped with a 4-12MHz linear probe and a conventional ultrasound device (LOGIC P9, GE Healthcare) with a 3-12MHz linear probe. The IMT of the common carotid artery was measured at 1.5cm proximal to the carotid bifurcation. The max IMT, mean IMT were measured on the far wall along the common carotid artery and analyzed by internal automatic software. The length of the automatic sampling frame is about 15mm; the measurement of the CIMT was obtained using a micrometer-scale value. The CIMT and the hemodynamic parameters were measured in longitudinal planes. In addition, hemodynamic parameters, i.e., peak systolic velocity (PSV), end diastolic velocity (EDV), artery systolic-diastolic ratio (S/D=PSV/EDV), resistive index (RI= (PSV\u0026ndash;EDV)/PSV), mean flow velocity (MFV), pulsatility index (PI= (PSV\u0026ndash;EDV)/MFV), acceleration time (AT), blood flow acceleration (ACCEL), time averaged mean velocity (TAMEAN) of carotid arteries were acquired and recorded using the Doppler ultrasound technique. The values of hemodynamic parameters were measured and calculated with a mean value obtained in 3 continuous cardiac cycles (Figure \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\n\u003cdiv class=\"Section2\" id=\"Sec3\"\u003e\n \u003ch2\u003e\u003cem\u003eStatistical\u003c/em\u003e analysis\u003c/h2\u003e\n \u003cp\u003eSPSS 19.0 (IBM, Armonk, NY, USA) statistical analysis software was used. The continuous data were expressed as mean \u0026plusmn; SD, and compared using a paired sample t-test. Non-normally distributed data were analyzed by Wilcoxon signed-rank test. Intraclass correlation coefficient (ICC) was used to assess inter-device agreement. The Bland-Altman plot and linear correlation analysis were used to assess repeatability and correlation of mean IMT. \u003cem\u003eP\u003c/em\u003e\u0026lt;0.05 represented that the difference was statistically significant.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Results","content":"\u003ch2\u003e1.Tissue mimicking ultrasound phantom\u003c/h2\u003e\n\u003cp\u003eTargets at four different depths were evaluated in this study. There were no difference in the longitudinal resolution and the axial resolution by using handheld ultrasound and conventional ultrasound (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable border=\"1\" id=\"Tab1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eComparisons of conventional and handheld ultrasounds values in ultrasound phantoms (x \u0026macr;\u0026plusmn; s)\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003ccolgroup cols=\"6\"\u003e\u003c/colgroup\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003eItem\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eConventional ultrasounds\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eHandheld ultrasounds\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003et/Z\u003c/em\u003e value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" colspan=\"6\"\u003e\n \u003cp\u003e\u003cstrong\u003eLongitudinal resolution (cm)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"4\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.01\u0026plusmn;0.02\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.01\u0026plusmn;0.03\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.111\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.919\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.99\u0026plusmn;0.02\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.99\u0026plusmn;0.01\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.567 \u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.215\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.02\u0026plusmn;0.02\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.01\u0026plusmn;0.03\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.000\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.000\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.01\u0026plusmn;0.02\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.00\u0026plusmn;0.02\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-2.449\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.092\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" colspan=\"6\"\u003e\n \u003cp\u003e\u003cstrong\u003eAxial resolution (cm)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.15\u0026plusmn;0.10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.20\u0026plusmn;0.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-1.000\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.317\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"3\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.10\u0026plusmn;0.14\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.20\u0026plusmn;0.08\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.000\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.391\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.03\u0026plusmn;0.15\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.10\u0026plusmn;0.14\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.000\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.391\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.08\u0026plusmn;0.17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.05\u0026plusmn;0.13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.264\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.809\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" colspan=\"6\"\u003e\n \u003cp\u003e\u003csup\u003ea\u003c/sup\u003e Paired \u003cem\u003et\u003c/em\u003e-test; \u003csup\u003eb\u003c/sup\u003e Wilcoxon signed-rank test\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003ch2\u003e2.Ex Vivo Experiments Findings\u003c/h2\u003e\n\u003cp\u003eThe IMT for the handheld ultrasound was 0.60 \u0026plusmn; 0.03mm, and that for the HE was 0.57\u0026plusmn;0.01mm. The difference of IMT were not statistically significant (\u003cem\u003eP\u003c/em\u003e༞0.05). The images were shown in Figure \u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e\n\u003ch2\u003eVolunteer Population\u003c/h2\u003e\n\u003cp\u003eWe examined 25 volunteers (2 males and 23 females) and repeated the scan after a week. Therefore, 47 ultrasound examinations were performed and 3 ultrasound examinations were lost. Loss of consented volunteers was due to withdrawn consent or time constraints. The volunteers ranged in age from 22 to 50 years, mean age was 35.20 \u0026plusmn; 8.68 years.\u003c/p\u003e\n\u003ch2\u003e3.Measurements of CCA using handheld and conventional ultrasound\u003c/h2\u003e\n\u003cp\u003eTo assess whether the carotid structure and hemodynamic parameters could be accurately carried out with the handheld ultrasound device, we compared the values of max IMT, mean IMT and hemodynamic parameters measurements from the handheld ultrasound with those from the conventional ultrasound. The comparisons of values between the handheld and conventional ultrasound were shown in Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e. The mean value of mean IMT was increased in handheld ultrasound group when compared with the conventional ultrasound group (0.50\u0026plusmn;0.07mm vs. 0.46\u0026plusmn;0.07mm, \u0026lt;0.001). However, the measurements had a good ICC of 0.79 for the mean IMT [95% confidence interval (CI): 0.66, 0.88]. The detailed analysis was shown in Table \u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e.\u0026nbsp;\u003c/p\u003e\u0026nbsp;\u003ctable border=\"1\" id=\"Tab2\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eChanges and comparisons of conventional and handheld ultrasounds values (x\u0026macr;\u0026plusmn;s) (n=47)\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eItem\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eConventional ultrasounds\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eHandheld ultrasounds\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003et/Z\u003c/em\u003e value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMax IMT (mm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.54\u0026plusmn;0.08\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.51\u0026plusmn;0.07\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-2.950\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.003\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean IMT (mm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.46\u0026plusmn;0.07\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.50\u0026plusmn;0.07\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-4.495\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePSV (cm/s)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e78.31\u0026plusmn;10.37\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e76.65\u0026plusmn;12.52\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.868\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.390\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eEDV (cm/s)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e25.2\u0026plusmn;3.45\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e21.89\u0026plusmn;4.54\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.402\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.34\u0026plusmn;0.22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.52\u0026plusmn;0.30\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-5.374\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.67\u0026plusmn;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.71\u0026plusmn;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-5.377\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eS/D\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3.14\u0026plusmn;0.47\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3.61\u0026plusmn;0.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-5.519\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eACCEL (cm/s\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e699.65\u0026plusmn;218.64\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e622.85\u0026plusmn;142.28\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2.701\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.010\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAT (s)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.08\u0026plusmn;0.02\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.09\u0026plusmn;0.01\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-4.148\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTAMEAN (cm/s)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e24.7\u0026plusmn;3.58\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e23.91\u0026plusmn;4.36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.186\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.242\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eHR (bpm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e72.87\u0026plusmn;8.18\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e74.4\u0026plusmn;8.82\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-2. 571\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.013\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" colspan=\"5\"\u003e\n \u003cp\u003eIMT: Intima-media thickness; PSV: Peak systolic velocity; EDV: End diastolic velocity; PI: Pulsatility index; RI: Resistive index; S/D: Systolic-diastolic ratio; ACCEL: Blood flow acceleration; AT: Acceleration time; TAMEAN: Time averaged mean velocity; HR: Heart rate\u003c/p\u003e\n \u003cp\u003e\u003csup\u003ea\u003c/sup\u003e Paired \u003cem\u003et\u003c/em\u003e-test; \u003csup\u003eb\u003c/sup\u003e Wilcoxon signed-rank test\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\u003e\u0026nbsp;\u003c/p\u003e\u0026nbsp;\u003ctable border=\"1\" id=\"Tab3\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eICC analysis for conventional ultrasounds vs handheld ultrasounds (n=47)\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eItem\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eICC (95% CI)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\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\u003eMax intima-media thickness (mm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.73 (0.56-0.84)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean intima-media thickness (mm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.79 (0.66-0.88)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePeak systolic velocity (cm/s)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.52 (0.13-0.73)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.008\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eEnd diastolic velocity (cm/s)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.58 (0.25-0.77)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.002\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePulsatility index\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.80 (0.65-0.89)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eResistive index\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.84 (0.72-0.91)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSystolic-diastolic ratio\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.70 (0.47-0.84)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBlood flow acceleration (cm/s\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.61 (0.31-0.78)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAcceleration time (s)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.29 (-0.28-0.60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.129\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTime averaged mean velocity (cm/s)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.51 (0.13-0.73)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.008\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eHeart rate (bpm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.94 (0.89-0.97)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;0.001\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\u003e\u003cbr\u003e\u003c/p\u003e\n\u003ch2\u003e4.Agreement and reproducibility of the handheld ultrasound\u003c/h2\u003e\n\u003cp\u003eTo determine the reproducibility of mean IMT using a handheld ultrasound, the operator performed scans and measurements on the volunteers after a week. Bland-Altman analysis showed that the mean and standard deviation of the difference in the mean IMT measurements of handheld ultrasounds before and after were (0.015 \u0026plusmn;0.057), and the mean and standard deviation of the difference in the mean IMT measurements of conventional ultrasounds before and after were (-0.004 \u0026plusmn;0.046). The two measurements showed a consistent trend between the differential and mean values (Fig. \u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003ea and c).\u003c/p\u003e\n\u003cp\u003eThe repeatability test showed the handheld ultrasounds measurements of mean IMT before and after were correlated (\u003cem\u003er\u003c/em\u003e = 0.680, \u003cem\u003eP\u003c/em\u003e \u0026lt; 0.01), and the linear regression equation was \u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003ey=0.117+0.739x\u003c/span\u003e\u003c/span\u003e. The conventional ultrasounds measurements of mean IMT before and after were highly correlated (\u003cem\u003er\u003c/em\u003e = 0.789, \u003cem\u003eP\u003c/em\u003e \u0026lt; 0.01), and the linear regression equation was \u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003ey=0.040+0.922x\u003c/span\u003e\u003c/span\u003e. These values correspond to good reproducibility for this handheld ultrasound. The detailed analysis was shown in Figure \u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003eb and d.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis observational study assessed the diagnostic feasibility of carotid artery structure and hemodynamic parameters using a handheld ultrasound. The main finding of this study was: The handheld ultrasound scans that focused on the basic assessment of carotid and hemodynamic parameters showed a moderate to good correlation with conventional ultrasound images.\u003c/p\u003e \u003cp\u003eAS is a chronic inflammatory disease caused by a variety of etiologies and risk factors, which can affect many blood vessels in the whole body. The development of progressive vascular AS is the cause of most cardiovascular diseases (CVD) \u003csup\u003e[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/sup\u003e. In the early stage of carotid atherosclerosis, a small amount of lipid will deposit on the intima, increasing CIMT. Previous studies have shown that the CIMT is an important indicator of arteriosclerosis and independent predictors of cardiovascular events \u003csup\u003e[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/sup\u003e. Usually, the ultrasound scan is the most widely used method for CCA with its simplicity, non-invasion and excellent reproducibility, and utilized to evaluate the artery hemodynamic status and the measurement of the CIMT.\u003c/p\u003e \u003cp\u003eHandheld ultrasound is a small portable device and is a rapidly evolving technology with significant challenges and opportunities. At present, it is mainly used in the preliminary screening of diseases in an emergency, operating room and community chronic disease management\u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e. The examination items include various examinations of the heart, carotid artery, liver, kidney, thyroid and other organs. It has gradually become one of the important examination instruments for volunteers with cardiovascular diseases \u003csup\u003e[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eOf course, concerns about the limited size of handheld ultrasound devices degrades the imaging quality, which reduces the diagnostic reliability have been raised \u003csup\u003e[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e. In addition, operator dependence, including high inter-and intra-operator variability, is crucial in using a handheld ultrasound device \u003csup\u003e[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/sup\u003e. In our study, the results showed the differences in CIMT and hemodynamic parameters value between handheld ultrasound and conventional ultrasound. The reasons for these errors in our study may relate to the differences in quality between the handheld and conventional ultrasound images and the lower blood flow sensitivity compared to conventional ultrasound. The variability of Doppler-derived carotid hemodynamic measures has many sources, such as a small diversity in the insonation angle may result in a large velocity diversity \u003csup\u003e[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]\u003c/sup\u003e. In addition, ultrasound protocols to measure CIMT may vary in the selections of the carotid segments, angles, and walls of the carotid artery measured \u003csup\u003e[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e; this partially increase random differences in making outline and measurement of CIMT. However, in this study, the results showed the good agreement for the measurements between the handheld ultrasound and conventional ultrasound imaging studies. Although the values in this study between handheld ultrasound and conventional ultrasound are significant difference, our results suggested that the differences of values could be accepted within the clinical range.\u003c/p\u003e \u003cp\u003eOur findings of handheld ultrasound are consistent with those in previously published studies. Jang et al. noted excellent agreement and repeatability between wireless handheld ultrasound and standard ultrasound in max-CIMT measurement \u003csup\u003e[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/sup\u003e. Prinz et al. found that handheld echocardiographic devices showed a moderate to perfect correlation with standard echocardiography \u003csup\u003e[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/sup\u003e. Notably, in our study, the reproducibility and consistency in assessing mean IMT using a handheld ultrasound device are good. These results suggested that the handheld ultrasound is effective as a screening tool for the identification of carotid artery structure and hemodynamic parameters disorders in clinical practice. Certainly, the differences could be reduced and reversed by successful image acquisition and assessment with improved intelligent analysis metabolism. Thus, this puts forward higher requirements in accuracy and sensitivity for handheld ultrasound equipment.\u003c/p\u003e \u003cp\u003eHowever, this technique can provide a more helpful tool for screening in carotid artery disease or imaging biomarkers for CVD and cardiovascular risk. The use of handheld ultrasound can realize the preliminary judgment of ultrasonic image abnormalities in settings such as the primary care office or the emergency department, which may provide more cost-effective and time-efficient than traditional ultrasound. It is believed that with the development of science and technology, the detection of the carotid artery by handheld ultrasound will be more convenient, objective and accurate.\u003c/p\u003e"},{"header":"Limitations","content":"\u003cp\u003eIn this study, we only scanned the carotid structure and hemodynamic parameters with high-frequency linear probes using handheld ultrasound; therefore, we cannot comment on the use of handheld ultrasound in other superficial organs\u0026rsquo; examinations with linear probes, such as thyroid, breast, or with other types of probes. In addition, experiments in vitro and volunteers under more complicated conditions, such as CCA plaques were not tested. These image quality and parameters comparison with conventional ultrasound should be examined in the future.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eConcerning primary assessment of carotid, the images obtained using handheld ultrasonic devices showed a moderate to good correlation with a conventional ultrasound system. The handheld ultrasound device can be used as a screening and follow-up tool to determine or exclude carotid artery abnormalities before the application of conventional ultrasound, and has the potential to be widely used as a diagnostic tool for carotid artery structure and hemodynamics examination, and it will bring more convenience to clinical work and better serve volunteers.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCIMT: carotid intima-media thickness\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAcknowledgements\u003c/h2\u003e\n\u003cp\u003eWe thank all of the patients involved in this study.\u003c/p\u003e\n\u003ch2\u003eAuthors\u0026rsquo; contributions\u003c/h2\u003e\n\u003cp\u003eZJL conceived the study and revised the manuscript. JXC designed and performed the experiments. LJ performed the data analyses and drafted the manuscript. CQS and LYT are involved in ultrasound examination and diagnosis. LFD analyzed and interpreted data. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003ch2\u003eFunding:\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eThis research was funded by Natural Science Foundation of Shanghai (21ZR1451400), Shanghai Jiading District Health and Family Planning Commission Fund (2021-KY-10) and Shanghai Songjiang District Science and Technology Project (18sjkjgg72, 18sjkjgg53).\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eEthics approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eThis study protocol was approved by the medical ethics committee of Shanghai General Hospital (2019KY009-4) and registered on the official website of China Clinical Trial Registration Center (ChiCTR2000035937).\u003c/p\u003e\n\u003ch2\u003eConsent for publication\u003c/h2\u003e\n\u003cp\u003eWritten informed consent was obtained from all the patients for publication of this manuscript and any accompanying images.\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials\u003c/h2\u003e\n\u003cp\u003eThe datasets used in the manuscript are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003ch2\u003eCompeting\u003cem\u003e\u0026nbsp;\u003c/em\u003einterests:\u003c/h2\u003e\n\u003cp\u003eThe authors declare that there is no conflict of interest with any financial organization or corporation or individual that can inappropriately influence this work.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eYan F, Sun Y, Mao Y, et al. Ultrasound Molecular Imaging of Atherosclerosis for Early Diagnosis and Therapeutic Evaluation through Leucocyte-like Multiple Targeted Microbubbles. \u003cem\u003eTheranostics.\u003c/em\u003e 2018;8(7):1879\u0026ndash;1891.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBarquera S, Pedroza-Tobias A, Medina C. Cardiovascular diseases in mega-countries: the challenges of the nutrition, physical activity and epidemiologic transitions, and the double burden of disease. \u003cem\u003eCurr Opin Lipidol.\u003c/em\u003e 2016;27(4):329\u0026ndash;344.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. \u003cem\u003eStroke.\u003c/em\u003e 2011;42(12):3651\u0026ndash;3654.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAkazawa S, Tojikubo M, Nakano Y, et al. Usefulness of carotid plaque (sum and maximum of plaque thickness) in combination with intima-media thickness for the detection of coronary artery disease in asymptomatic patients with diabetes. \u003cem\u003eJ Diabetes Investig.\u003c/em\u003e 2016;7(3):396\u0026ndash;403.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJeevarethinam A, Venuraju S, Weymouth M, Atwal S, Lahiri A. Carotid intimal thickness and plaque predict prevalence and severity of coronary atherosclerosis: a pilot study. \u003cem\u003eAngiology.\u003c/em\u003e 2015;66(1):65\u0026ndash;69.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLee S, Cho GY, Kim HS, et al. Common carotid intima-media thickness as a risk factor for outcomes in Asian patients with acute ST-elevation myocardial infarction. \u003cem\u003eCan J Cardiol.\u003c/em\u003e 2014;30(12):1620\u0026ndash;1626.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCohn JN. Arterial stiffness, vascular disease, and risk of cardiovascular events. \u003cem\u003eCirculation.\u003c/em\u003e 2006;113(5):601\u0026ndash;603.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi ZJ, Liu Y, Du LF, Luo XH. Evaluating arterial stiffness in type 2 diabetes patients using ultrasonic radiofrequency. \u003cem\u003eJ Huazhong Univ Sci Technolog Med Sci.\u003c/em\u003e 2016;36(3):442\u0026ndash;448.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eD\u0026iacute;az-G\u0026oacute;mez JL, Mayo PH, Koenig SJ. Point-of-Care Ultrasonography. \u003cem\u003eN Engl J Med.\u003c/em\u003e 2021;385(17):1593\u0026ndash;1602.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePanoulas VF, Daigeler AL, Malaweera AS, et al. Pocket-size hand-held cardiac ultrasound as an adjunct to clinical examination in the hands of medical students and junior doctors. \u003cem\u003eEur Heart J Cardiovasc Imaging.\u003c/em\u003e 2013;14(4):323\u0026ndash;330.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGalderisi M, Santoro A, Versiero M, et al. Improved cardiovascular diagnostic accuracy by pocket size imaging device in non-cardiologic outpatients: the NaUSiCa (Naples Ultrasound Stethoscope in Cardiology) study. \u003cem\u003eCardiovasc Ultrasound.\u003c/em\u003e 2010;8:51.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBhagra A, Tierney DM, Sekiguchi H, Soni NJ. Point-of-Care Ultrasonography for Primary Care Physicians and General Internists. \u003cem\u003eMayo Clin Proc.\u003c/em\u003e 2016;91(12):1811-1827.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBlanco P, Volpicelli G. Common pitfalls in point-of-care ultrasound: a practical guide for emergency and critical care physicians. \u003cem\u003eCrit Ultrasound J.\u003c/em\u003e 2016;8(1):15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMolinari F, Liboni W, Pavanelli E, Giustetto P, Badalamenti S, Suri JS. Accurate and automatic carotid plaque characterization in contrast enhanced 2-d ultrasound images. \u003cem\u003eAnnu Int Conf IEEE Eng Med Biol Soc.\u003c/em\u003e 2007;2007:335\u0026ndash;338.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBrattain LJ, Telfer BA, Dhyani M, Grajo JR, Samir AE. Machine learning for medical ultrasound: status, methods, and future opportunities. \u003cem\u003eAbdom Radiol (NY)\u003c/em\u003e. 2018;43(4):786\u0026ndash;799.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLui EY, Steinman AH, Cobbold RS, Johnston KW. Human factors as a source of error in peak Doppler velocity measurement. \u003cem\u003eJ Vasc Surg.\u003c/em\u003e 2005;42(5):972\u0026ndash;979.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGill RW. Measurement of blood flow by ultrasound: accuracy and sources of error. \u003cem\u003eUltrasound Med Biol.\u003c/em\u003e 1985;11(4):625\u0026ndash;641.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTouboul PJ. Intima-media thickness of carotid arteries. \u003cem\u003eFront Neurol Neurosci.\u003c/em\u003e 2015;36:31\u0026ndash;39.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJang AY, Ryu J, Oh PC, Moon J, Chung WJ. Feasibility and Applicability of Wireless Handheld Ultrasound Measurement of Carotid Intima-Media Thickness in Patients with Cardiac Symptoms. \u003cem\u003eYonsei Med J.\u003c/em\u003e 2020;61(2):129\u0026ndash;136.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePrinz C, Dohrmann J, van Buuren F, et al. Diagnostic performance of handheld echocardiography for the assessment of basic cardiac morphology and function: a validation study in routine cardiac patients. \u003cem\u003eEchocardiography.\u003c/em\u003e 2012;29(8):887\u0026ndash;894.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"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":"Handheld ultrasound scanner, Carotid artery, Carotid intima-media thickness, Ultrasound","lastPublishedDoi":"10.21203/rs.3.rs-1172637/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-1172637/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective: \u003c/strong\u003eThe study aimed to estimate the feasibility and accuracy of carotid intima-media thickness (CIMT) and hemodynamic parameters measurement in a handheld ultrasound device.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e Utilizing an ex vivo pig carotid artery sample, CIMT was measured with a handheld ultrasound and compared with histopathology. Then we performed a carotid ultrasound on 25 volunteers using a handheld ultrasound device and a conventional ultrasound system. After a week, these volunteers were scanned again by the same observer. Assessments of the max IMT, mean IMT and hemodynamic parameters (PSV, EDV, PI, RI, S/D, ACCEL, AT, TAMEAN) were compared. Intraclass correlation coefficient (ICC) was used to assess inter-device agreement. Repeatability and correlation of mean IMT were analyzed by Bland–Altman Plots and linear correlation analysis. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e The mean IMT measured from the common carotid artery by handheld ultrasound showed good agreement (ICC=0.79) with conventional ultrasound. Furthermore, we obtained good repeatability and a consistent trend in the mean value of IMT before and after (r = 0.680, P \u0026lt; 0.01). In addition, the max IMT and the hemodynamic parameters (PSV, EDV, S/D, ACCEL, TAMEAN) showed moderate agreement (ICC=0.73, 0.52, 0.58, 0.70, 0.61, 0.51, respectively). The PI, RI and HR values were excellent agreement with conventional ultrasound (ICC=0.80, 0.84, 0.94). \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e About the basic assessment of carotid, the images and parameters obtained using handheld ultrasound showed a moderate to excellent agreement with conventional ultrasound. The handheld ultrasonic devices can be widely used as a diagnostic tool for carotid artery structure and hemodynamics examination.\u003c/p\u003e","manuscriptTitle":"Handheld Versus Conventional Ultrasound for Assessing Carotid Artery in Routine Volunteers","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2021-12-22 18:31:31","doi":"10.21203/rs.3.rs-1172637/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":"f1535349-201c-47e6-8ce7-0b46ff53877d","owner":[],"postedDate":"December 22nd, 2021","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":9324173,"name":"Nuclear Medicine \u0026 Medical Imaging"}],"tags":[],"updatedAt":"2022-03-16T16:14:10+00:00","versionOfRecord":[],"versionCreatedAt":"2021-12-22 18:31:31","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-1172637","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-1172637","identity":"rs-1172637","version":["v1"]},"buildId":"7rjqhiLT3MXkJMwkYKINL","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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