Validation of a novel professional automated auscultatory upper-arm cuff blood pressure monitor in a general population according to the AAMI/ESH/ISO Universal Standard: KOROT V2 Doctor (InBody BPBIO280KV).

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2024-08-01 Epub Date: 2024-05-17 DOI:10.1097/MBP.0000000000000707

Aikaterini Theodosiadi, Vasileios Ntousopoulos, Angeliki Ntineri, Panagiota Stathopoulou, Ariadni Menti, Konstantinos G Kyriakoulis, Anastasios Kollias, George S Stergiou

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引用次数: 0

Abstract

Objective: A novel automated auscultatory upper arm cuff blood pressure (BP) monitor KOROT V2 Doctor (InBody BPBIO280KV) was developed for professional use. An electronic stethoscope embedded in the device cuff records the Korotkoff sounds, which are graphically displayed during deflation allowing visual evaluation by the healthcare professional. The device provides automated measurements of BP and this study evaluated its accuracy.

Methods: The requirements of the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018) and its Amendment 1.2020-01 were applied. Participants were recruited to fulfill the age, sex, BP, arm circumference, and cuff distribution criteria of the Universal Standard and its Amendment in a general population using the same arm sequential measurement method. Three cuffs of the test device were tested for arm circumference 23-28, 28-35, and 33-42 cm.

Results: Data from 85 individuals were analyzed [mean age: 56.4 ± 16.0 (SD) years, 50 men, arm circumference 23-42 cm]. For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N = 255) was -1.3 ± 6.0/1.5 ± 5.0 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For Criterion 2, the SD of the averaged BP differences per individual (N = 85) was 4.61/3.48 mmHg (systolic/diastolic; threshold ≤6.82/6.78 mmHg).

Conclusion: The KOROT V2 Doctor (InBody BPBIO280KV) device for professional use, which provides automated auscultatory measurements with visual display of the Korotkoff sounds, comfortably fulfills all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a general population and can be recommended for clinical use.

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根据 AAMI/ESH/ISO 通用标准在普通人群中验证新型专业自动听诊式上臂袖带血压计：KOROT V2 Doctor (InBody BPBIO280KV)。

目的：为专业人员开发了一种新型自动听诊式上臂袖带血压（BP）监测仪 KOROT V2 Doctor（InBody BPBIO280KV）。设备袖带中嵌入的电子听诊器可记录 Korotkoff 音，放气时以图形显示，以便医护人员进行可视化评估。该设备可自动测量血压，本研究对其准确性进行了评估：研究采用了医疗仪器促进协会/欧洲高血压学会/国际标准化组织（AAMI/ESH/ISO）通用标准（ISO 81060-2:2018）及其 1.2020-01 修正案的要求。采用相同的手臂顺序测量方法，在普通人群中招募符合通用标准及其修订版规定的年龄、性别、血压、臂围和袖带分布标准的参与者。测试设备的三个袖带分别测试了臂围 23-28、28-35 和 33-42 厘米：分析了 85 人的数据[平均年龄：56.4 ± 16.0 (SD) 岁，男性 50 人，臂围 23-42 厘米]。对于验证标准 1，测试设备和参考血压读数（N = 255）之间的平均差（±SD）为-1.3 ± 6.0/1.5 ± 5.0 mmHg（收缩压/舒张压；阈值≤5 ± 8 mmHg）。对于标准 2，每个人（N = 85）的平均血压差异的 SD 为 4.61/3.48 mmHg（收缩压/舒张压；阈值≤6.82/6.78 mmHg）：KOROT V2 Doctor（InBody BPBIO280KV）专业设备可提供自动听诊测量，并可视化显示 Korotkoff 音，在普通人群中可轻松满足 AAMI/ESH/ISO 通用标准（ISO 81060-2:2018）的所有要求，建议临床使用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Blood Pressure Monitoring 医学-外周血管病

CiteScore

2.00

自引率

7.70%

发文量

110

审稿时长

>12 weeks

期刊介绍： Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research. This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.