Validation of the ABPMpro ambulatory blood pressure monitor in the general population according to AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018).

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE Blood Pressure Monitoring Pub Date : 2023-06-01 DOI:10.1097/MBP.0000000000000640

Bernhard Roth, Tomas Lucca Bothe, Andreas Patzak, Niklas Pilz

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Abstract

Objective: The objective of this study is to evaluate the accuracy of the oscillometric upper-arm device ABPMpro (SOMNOmedics) for ambulatory blood pressure measurement in the general population according to 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) at rest and during dynamic exercise.

Methods: Subjects were recruited to fulfill the age, sex, blood pressure (BP) and cuff distribution criteria of the AAMI/ESH/ISO standard using the same arm sequential BP measurement method. Three appropriate cuff sizes (18-24, 24-34 and 34-46 cm) of the tested device were used for the arm-varying circumferences. The inflation and deflation measurement modes of the ABPMpro were investigated.

Results: For the general validation study, 100 subjects were recruited and 90 were analyzed. For validation criterion (1), the mean ± SD of the differences between ABPMpro and reference BP was 0.7 ± 7.3/-0.7 ± 5.8 mmHg (systolic/diastolic) for inflation and 1.4 ± 7.7/-0.6 ± 6.1 mmHg for deflation measurements. For criterion (2), the SD of the averaged BP differences per subject was 5.98/5.10 mmHg for inflation and 6.46/5.36 mmHg for deflation measurements, thereby passing the threshold. In the ambulatory validation study ( N = 36), the mean difference was -1.2 ± 7.9/ 2.4 ± 6.6 mmHg for inflation and -0.7 ± 7.6/3.1 ± 7.0 mmHg for deflation measurements.

Conclusion: The ABPMpro device fulfilled the ISO 81060-2:2018 requirements in the general population and in the ambulatory setting and can therefore be recommended for clinical use.

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根据AAMI/ESH/ISO通用标准(ISO 81060-2:2018)在普通人群中验证ABPMpro动态血压监测仪。

目的:本研究的目的是根据医疗器械进步协会/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)评估上臂振荡装置ABPMpro (SOMNOmedics)用于普通人群静止和动态运动时动态血压测量的准确性。方法:招募符合AAMI/ESH/ISO标准的年龄、性别、血压(BP)和袖带分布标准的受试者，采用同臂序贯血压测量法。不同臂围采用三种合适的袖带尺寸(18- 24cm, 24-34 cm和34-46 cm)。研究了ABPMpro的通货膨胀和通货紧缩测量模式。结果:在一般验证研究中，招募了100名受试者，分析了90名受试者。对于验证标准(1)，ABPMpro与参考血压之间的差异的平均值±SD为膨胀测量值0.7±7.3/-0.7±5.8 mmHg(收缩压/舒张压)，而紧缩测量值为1.4±7.7/-0.6±6.1 mmHg。对于标准(2)，每位受试者的平均血压差异的SD值在通货膨胀时为5.98/5.10 mmHg，在通货紧缩时为6.46/5.36 mmHg，从而通过了阈值。在动态验证研究中(N = 36)，通货膨胀测量的平均差异为-1.2±7.9/ 2.4±6.6 mmHg，通货紧缩测量的平均差异为-0.7±7.6/3.1±7.0 mmHg。结论:ABPMpro设备在普通人群和门诊环境中符合ISO 81060-2:2018的要求，因此可以推荐用于临床。

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.