Tan V Bui, Dean S Picone, Wojciech P Kosmala, Michał J Kosowski, Jowita Zachwyc, Giacomo Pucci, Alessio Arrivi, Rosa Curcio, Martin G Schultz, J Andrew Black, Nathan Dwyer, Philip Roberts-Thomson, Sarang Paleri, Heath Adams, James E Sharman
{"title":"Validation assessment of a cuff-based central blood pressure device according to Artery Society recommendations.","authors":"Tan V Bui, Dean S Picone, Wojciech P Kosmala, Michał J Kosowski, Jowita Zachwyc, Giacomo Pucci, Alessio Arrivi, Rosa Curcio, Martin G Schultz, J Andrew Black, Nathan Dwyer, Philip Roberts-Thomson, Sarang Paleri, Heath Adams, James E Sharman","doi":"10.1097/MBP.0000000000000754","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000754","url":null,"abstract":"<p><strong>Objective: </strong>Uscom BP+ is a cuff-based blood pressure (BP) device designed to noninvasively estimate central BP as distinct from conventional brachial BP. This study aimed to assess the accuracy of the Uscom BP+ device compared with invasively measured BP.</p><p><strong>Methods: </strong>Automated noninvasive cuff central BP (using the Uscom BP+ device) and invasive central aortic BP were recorded simultaneously in 191 participants (65% male, aged 66 ± 11 years) receiving coronary angiography at three independent research sites in Australia, Poland, and Italy. Validation procedures were undertaken according to the Artery Society recommendations and with a minimally acceptable error (mean ± SD) of ≤5 ± ≤8 mmHg as pass criteria.</p><p><strong>Results: </strong>Using the device default calibration technique [brachial cuff systolic blood pressure (SBP) and diastolic blood pressure (DBP)], cuff central SBP underestimated invasive central SBP [mean (SD) difference: -10.2 (11.2) mmHg] and cuff central DBP overestimated invasive central DBP [mean (SD) difference: 9.8 (8.5) mmHg]. When calibrating by brachial cuff mean arterial pressure and DBP, SBP accuracy was improved, but variability remained high [mean (SD) difference: -6.3 (14.4) mmHg, P = 0.004 vs. default calibration, whereas DBP accuracy and variability remained similar [mean (SD) difference: 10.9 (8.5) mmHg, P = 0.19 vs. default calibration].</p><p><strong>Conclusion: </strong>The Uscom BP+ cuff device does not pass the Artery Society accuracy criteria compared with invasively measured central BP.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143973638","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Validation of the YuWell YE990 medical automatic electronic blood pressure monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018/Amd.1:2020).","authors":"Dongju Xu, Haiqin Tang, Cuidi Wang, Hui Cheng, Wenhui Wu, Qi Lu, Hejun Liu","doi":"10.1097/MBP.0000000000000755","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000755","url":null,"abstract":"<p><p>To validate the accuracy of the YuWell YE990 automated oscillometric upper-arm medical blood pressure (BP) monitor in adults according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal standards (ISO 81060-2:2018 and Amendment 1:2020). Participants were recruited to meet the age, sex, BP, and cuff distribution criteria of the AAMI/ESH/ISO standards. BP was measured using a mercury sphygmomanometer (reference device) and YE990 (test device) following a same-arm sequential protocol with two trained observers and a supervisor. Bland-Altman plots were used to assess agreement, and scatter plots were used to assess the performance across varying arm sizes. Ninety-nine subjects were recruited and 85 were analyzed. The YE990 passed the accuracy requirements of the AAMI/ESH/ISO standards, with mean differences of 0.4 ± 6.31 mmHg for systolic BP and -0.9 ± 6.28 mmHg for diastolic BP for validation criterion 1. For validation criterion 2, the SD of the average BP difference between the test device and reference BP per subject was 5.00/5.70 mmHg (systolic/diastolic). YuWell YE990 meets the AAMI/ESH/ISO universal accuracy standard (ISO 81060-2:2018+Amd.1:2020) and is recommended for clinical use.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143953119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Song Meiyan, Junwei Zheng, Wu Ying, Chen Wen, Xu Kaizu, Liming Lin
{"title":"Influence of cuff size on the accuracy of supine blood pressure measurement.","authors":"Song Meiyan, Junwei Zheng, Wu Ying, Chen Wen, Xu Kaizu, Liming Lin","doi":"10.1097/MBP.0000000000000752","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000752","url":null,"abstract":"<p><strong>Objective: </strong>The discrepancy in blood pressure (BP) measurements while in a supine position using an upper-arm automated sphygmomanometer equipped with cuffs of varying sizes remains unresolved.</p><p><strong>Methods: </strong>In this single-center, randomized crossover trial, a total of 223 inpatients from the Affiliated Hospital of Putian University were enrolled between August and September 2023. Three sets of triplicate BP measurements were obtained while the participants were in a supine position using an automated sphygmomanometer with randomly assigned appropriately sized, undersized, or oversized BP cuffs.</p><p><strong>Results: </strong>The average age of the subjects was 65.1 ± 18.4 years, with 109 (48.9%) being male and 78 (35%) having coexisting hypertension. Based on the measured mid-arm circumference, a small-sized, regular-sized, and large-sized BP cuff was deemed appropriate for 50, 113, and 60 participants, respectively. In patients requiring small-sized cuffs, the use of regular and large-sized cuffs resulted in a significant reduction in systolic BP by -4.0 [95% confidence interval (CI): -9.8 to 1.9] mmHg and -6.9 (95% CI: -8.0 to -5.8) mmHg, respectively, as well as diastolic BP by -3.4 (95% CI: -8.0 to 1.2) mmHg and -4.1 (95% CI: -5.3 to 2.8) mmHg, respectively. In contrast, among patients requiring large-sized cuffs, the use of small and regular-sized cuffs increased systolic BP by 6.2 (95% CI: 4.2 to 8.2) mmHg and 2.3 (95% CI: -1.4 to 6.1) mmHg, respectively, and diastolic BP increased by 2.6 (95% CI: 1.5 to 3.7) mmHg and 0.2 (95% CI: -4.7 to 5.2) mmHg, respectively.</p><p><strong>Conclusion: </strong>Our findings suggest that miscuffing affects supine BP measured by an automated sphygmomanometer.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143953495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Haiwen Li, Li Liu, Xianbi Tang, Kaiquan Jing, Chuzheng Pan
{"title":"Association between inter-arm blood pressure difference and prevalence of renal artery stenosis in patients with ischemic stroke.","authors":"Haiwen Li, Li Liu, Xianbi Tang, Kaiquan Jing, Chuzheng Pan","doi":"10.1097/MBP.0000000000000753","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000753","url":null,"abstract":"<p><strong>Objective: </strong>Renal artery stenosis (RAS) which is a potentially reversible cause of hypertension and renal insufficiency is associated with poor prognosis in ischemic stroke patients. The inter-arm blood pressure difference (IABD) is independently related to the atherosclerosis of the arteries. This study was to evaluate the relationship of RAS with IABD in ischemic stroke patients.</p><p><strong>Materials and methods: </strong>This study was a cross-sectional observational study of consecutive patients with ischemic stroke who had not a history of RAS. Abdominal aortography was performed to screen for RAS after the cerebrovascular diagnostic procedure. RAS was defined as the presence of ≥50% stenosis in either renal artery. Univariate and multivariate analysis were performed to investigate the association of the clinical variables including IABD with RAS.</p><p><strong>Results: </strong>RAS and systolic IABD ≥ 10 mmHg were detected in 62 (14.7%) and 142 (33.6%) of all ischemic stroke patients (n = 422), respectively. Patients with systolic IABD ≥ 10 mmHg were more likely to have RAS than patients without (59.7 vs 29.2%, P < 0.001). The logistic regression analysis showed that systolic IABD ≥ 10 mmHg was independently associated with RAS (odds ratio, 3.67; 95% confidence interval: 2.02-6.65; P < 0.001).</p><p><strong>Conclusion: </strong>Measuring SBP between arms may help identify individuals with RAS in ischemic stroke patients.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical evaluation of the BP2 upper arm blood pressure monitor according to the ISO 81060-2:2018+Amd 1:2020.","authors":"Wan Chen, Yuhan Xiang, Zizhuo Zhu, Fujun Shang","doi":"10.1097/MBP.0000000000000751","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000751","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the clinical measurement accuracy of the BP2 oscillometric upper arm blood pressure monitor in the general population according to the ISO 81060-2:2018+Amd 1:2020 standard.</p><p><strong>Methods: </strong>Participants were recruited and the same arm sequential method was used for blood pressure measurement according to the ISO 81060-2:2018+Amd 1:2020. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference results.</p><p><strong>Results: </strong>A total of 85 participants were included in the final analysis. For the validation criterion 1, the mean ± SD of the differences between the test device and reference readings was -2.93 ± 7.65 and -2.40 ± 6.82 mmHg for systolic and diastolic blood pressure, respectively. For criterion 2, the ±SD of the averaged differences between the test device and reference readings per participant was ±6.16 and ±5.74 mmHg for systolic and diastolic blood pressure, respectively.</p><p><strong>Conclusion: </strong>The BP2 upper arm blood pressure monitor passed all the requirements of the ISO 81060-2:2018+Amd 1:2020 standard and can be recommended for clinical use and self-measurement in the general population.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143762799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Development of hypertension in individuals with high normal blood pressure is related with sympathetic drive, arterial stiffness, and exercise blood pressure.","authors":"Theodoros Kalos, Kyriakos Dimitriadis, Fotis Tatakis, Nikolaos Pyrpyris, Eleni Manta, Niki Kakouri, Christos Fragoulis, Panagiotis Tsioufis, Dimitrios Konstantinidis, Theodoros Papaioannou, Dimitrios Tousoulis, Konstantina Aggeli, Konstantinos Tsioufis","doi":"10.1097/MBP.0000000000000750","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000750","url":null,"abstract":"<p><strong>Background: </strong>High normal blood pressure (HNBP) is common in adults worldwide and is associated with a greater likelihood of developing hypertension. Thus, identifying those at risk is crucial, in order to intervene early and reduce future cardiovascular risk. This study aims to examine the role of sympathetic nervous system (SNS), aortic stiffness, and blood pressure (BP) response to exercise as predictors for development of hypertension in individuals with HNBP.</p><p><strong>Methods: </strong>One hundred individuals with HNBP were included in the study. Baseline anthropometric characteristics, BP levels, an electrocardiogram, and an echocardiogram were obtained. In order to evaluate the effect of SNS, aortic stiffness, and exercise response in the transition from the prehypertensive to hypertensive phenotype, we measured the levels of muscle sympathetic nerve activity (MSNA), pulse wave velocity (PWV), and exaggerated BP response (EBPR) to cardiopulmonary exercise, respectively.</p><p><strong>Results: </strong>At 3 years follow up, 40 patients (40%) developed hypertension. Baseline characteristics were similar between the two groups. Those who developed hypertension had sympathetic overactivation, as indicated by the higher mean values of MSNA (35 ± 4.4 vs 28 ± 3.8 bursts per minute; P = 0.003), increased aortic stiffness, and PWV (8.2 ± 0.7 vs 7.2 ± 0.5 m/s; P < 0.001), as well as an EBPR to exercise (P < 0.001).</p><p><strong>Conclusion: </strong>Increased values of MSNA, PWV, and EBPR were found to be statistically related with hypertension development in HNBP phenotypes. These markers could be of great clinical use in identifying prehypertensives at high risk for developing hypertension.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143762860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood Pressure MonitoringPub Date : 2025-04-01Epub Date: 2024-11-14DOI: 10.1097/MBP.0000000000000734
Sebastiano Cicco, Marialuisa Sveva Marozzi, Gabriella Schirosi, Francesco Corvasce, Daniele Egidio Romano, Angelo Vacca, Pietro Nazzaro
{"title":"Efficient use of the TM-2441 ambulatory blood pressure measurement device in patients with diabetes.","authors":"Sebastiano Cicco, Marialuisa Sveva Marozzi, Gabriella Schirosi, Francesco Corvasce, Daniele Egidio Romano, Angelo Vacca, Pietro Nazzaro","doi":"10.1097/MBP.0000000000000734","DOIUrl":"10.1097/MBP.0000000000000734","url":null,"abstract":"<p><strong>Background and objective: </strong>Ambulatory blood pressure monitoring (ABPM) requires automatic measurement and the use of a validated device, according to current guidelines and international standardization. The TM-2441 (A&D Co. Ltd, Tokyo, Japan) ABPM device is small, lightweight, and suitable for use in ambulatory settings. It was validated against the ISO 81060-2:2013 standard in the general population. This study investigated the reliability of the ABPM device for patients with type 2 diabetes.</p><p><strong>Methods: </strong>Individuals aged more than 12 years affected with type 2 diabetes were recruited by our outpatient clinic. The blood pressure assessment was performed using the opposite limb simultaneous measurement according to the updated ISO 81060-2:2018.</p><p><strong>Results: </strong>Forty-five subjects were included in the clinical investigation. The mean difference between blood pressure values measured by the TM-2441 ABPM device and the reference sphygmomanometer was within limits allowed by the ISO standard. Bland-Altman plots of the measurements and differences between the values obtained from the study device and those from the reference device showed no systematic variations in error. It was not possible to perform a stress test in most patients due to refusal or poor physical condition.</p><p><strong>Conclusion: </strong>The TM-2441 ABPM device fulfilled all the requirements of the ISO standard for ambulatory testing not only in a general population but also in the subgroup of subjects with type 2 diabetes.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"82-85"},"PeriodicalIF":1.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142680713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood Pressure MonitoringPub Date : 2025-04-01Epub Date: 2024-11-26DOI: 10.1097/MBP.0000000000000736
Jia-Hui Xia, Yi-Bang Cheng, Ting-Yan Xu, Qian-Hui Guo, Chak-Ming Chan, Lei-Xiao Hu, Yan Li, Ji-Guang Wang
{"title":"Effect of a calcium-channel blocker and β-blocker combination on reading-to-reading blood pressure variability: a randomized crossover trial.","authors":"Jia-Hui Xia, Yi-Bang Cheng, Ting-Yan Xu, Qian-Hui Guo, Chak-Ming Chan, Lei-Xiao Hu, Yan Li, Ji-Guang Wang","doi":"10.1097/MBP.0000000000000736","DOIUrl":"10.1097/MBP.0000000000000736","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to investigate the efficacy of the nitrendipine/atenolol combination in comparison with standard-dose nitrendipine or atenolol monotherapy in reducing blood pressure (BP) and blood pressure variability (BPV) as assessed by ambulatory BP monitoring.</p><p><strong>Methods: </strong>In a randomized, crossover trial, 32 patients (30-65 years) with grade 1 hypertension and elevated daytime reading-to-reading BPV were randomly assigned to receive either the nitrendipine/atenolol combination (10/20 mg) or standard-dose nitrendipine (10 mg) or atenolol (25 mg) monotherapy for 6 weeks, followed by a crossover to another treatment for 6 weeks.</p><p><strong>Results: </strong>The final analysis included 31 patients (mean [±SD] age, 49.2 ± 9.6 years) and 12 men. The nitrendipine/atenolol combination significantly reduced from baseline clinic and ambulatory BP and pulse rate ( P ≤ 0.002), and 24 h and daytime systolic and diastolic BPV as assessed by SD and average real variability ( P ≤ 0.042), but not the coefficient of variation nor nighttime BPV indices ( P ≥ 0.06). Significant differences between the nitrendipine/atenolol combination and nitrendipine or atenolol monotherapy at the end of treatment were observed in clinic BP and pulse rate ( P ≤ 0.042), but not in 24 h, daytime and nighttime blood pressure and pulse rate, except for daytime DBP and 24 h and daytime pulse rate ( P ≤ 0.049). There were no significant differences in BPV between the combination and monotherpy groups at the end of treatment ( P ≥ 0.25).</p><p><strong>Conclusion: </strong>The nitrendipine/atenolol combination reduced daytime reading-to-reading BPV, but did not show superiority to nitrendipine or atenolol monotherapy.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"73-81"},"PeriodicalIF":1.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142999312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Validation of the ANDON KD-7920 wrist blood pressure monitor in general population according to the ISO 81060-2:2018+AMD1:2020 protocol.","authors":"Duan Li, Yiming Li, Jiaheng Li, Yuan Gu, Fujun Shang","doi":"10.1097/MBP.0000000000000740","DOIUrl":"10.1097/MBP.0000000000000740","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to evaluate the accuracy of the ANDON KD-7920 oscillometric wrist blood pressure monitor in general population according to the ISO 81060-2:2018+AMD1:2020.</p><p><strong>Methods: </strong>The same arm sequential method was used for blood pressure measurement among qualified participants according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the criteria of the protocol, and the Bland-Altman scatter plot was used to present the difference between the test device and reference results.</p><p><strong>Results: </strong>A total of 90 participants were included in the study. According to criterion 1 of the validation protocol, the mean ± SD of the differences between the test device and reference readings was 0.76 ± 6.23 mmHg and -0.13 ± 5.57 mmHg for systolic and diastolic blood pressure, respectively, which met the requirements of less than 5 ± 8 mmHg. According to the criterion 2, the average differences between the test device and reference readings per participant were 0.76 ± 5.56 mmHg and -0.13 ± 5.27 mmHg for systolic and diastolic blood pressure, respectively, which also met the requirements.</p><p><strong>Conclusion: </strong>The ANDON KD-7920 wrist blood pressure monitor passed all the requirements of the ISO 81060-2:2018+AMD1:2020 and can be recommended for clinical use and self-measurement in general population.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"93-96"},"PeriodicalIF":1.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142999260","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood Pressure MonitoringPub Date : 2025-04-01Epub Date: 2024-12-17DOI: 10.1097/MBP.0000000000000739
Beate Botta, Carsten Bramlage, Violetta Hachaturyan, Lena Jost, Peter Bramlage
{"title":"Validation of the Microlife BP3T01-1B blood pressure monitoring device in adults and adolescents according to the ISO 81060-2:2018 protocol.","authors":"Beate Botta, Carsten Bramlage, Violetta Hachaturyan, Lena Jost, Peter Bramlage","doi":"10.1097/MBP.0000000000000739","DOIUrl":"10.1097/MBP.0000000000000739","url":null,"abstract":"<p><strong>Background: </strong>Accurate measurement of blood pressure (BP) is crucial for the diagnosis and ongoing management of hypertension. Only devices that have been validated using an established protocol should be used to measure BP. The aim of this study was to validate the Microlife BP3T01-1B, an automated upper-arm BP measuring device, according to the DIN EN ISO 81060-2:2018-11 (ANSI/AAMI/ISO 81060-2:2018) standard protocol.</p><p><strong>Methods: </strong>BP measurements were performed in 85 adults and adolescents (age range: 13-86 years) using the same-arm sequential method of the DIN EN ISO 81060-2:2018-11 protocol, alternating between the test device and a reference mercury sphygmomanometer.</p><p><strong>Results: </strong>A total of 255 valid comparisons were available for the analysis of criterion 1. The mean ± SD difference between the test device and the reference device values was -2.56 ± 7.53 mmHg for SBP and -3.10 ± 5.65 mmHg for DBP. The mean differences met the pass criterion of less than or equal to ±5 mmHg and the SD values met the pass criterion of ≤8 mmHg. All 85 participants were included in the analysis of criterion 2. The mean ± SD intraindividual difference between the test and reference devices was -2.56 ± 6.15 mmHg for SBP and -3.10 ± 4.85 mmHg for DBP. Both were within the required pass range of SD ≤6.43 mmHg for SBP and SD ≤6.20 mmHg for DBP.</p><p><strong>Conclusion: </strong>The Microlife BP3T01-1B BP monitoring device fulfilled the criteria of the DIN EN ISO 81060-2:2018-11 (ANSI/AAMI/ISO 81060-2:2018) protocol in a general population and can be recommended for the measurement of BP in adults and adolescents.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"86-92"},"PeriodicalIF":1.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142999398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}