Doctor's office, Würzburg, Germany.
Institute of Translational Physiology, Charite - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Blood Press Monit. 2023 Jun 1;28(3):158-162. doi: 10.1097/MBP.0000000000000640. Epub 2023 Apr 5.
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.
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.
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.
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.
本研究旨在根据医疗器械促进协会/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）评估振臂式袖带设备 ABPMpro（ SOMNOmedics ）在一般人群中的动态血压测量准确性，包括休息时和运动时。
采用相同的手臂顺序血压测量方法，根据 AAMI/ESH/ISO 标准的年龄、性别、血压（BP）和袖带分布标准招募受试者。使用测试设备的三个合适袖带尺寸（18-24、24-34 和 34-46cm）来适应不同的臂围。研究了 ABPMpro 的充气和放气测量模式。
对于一般验证研究，共招募了 100 名受试者，其中 90 名进行了分析。对于验证标准（1），ABPMpro 与参考血压之间的差异平均值±标准偏差为充气时 0.7±7.3/-0.7±5.8mmHg（收缩压/舒张压），放气时 1.4±7.7/-0.6±6.1mmHg。对于标准（2），每个受试者的平均 BP 差异的 SD 为充气时 5.98/5.10mmHg，放气时 6.46/5.36mmHg，因此超过了阈值。在动态验证研究（N=36）中，充气时的平均差值为-1.2±7.9/2.4±6.6mmHg，放气时为-0.7±7.6/3.1±7.0mmHg。
ABPMpro 设备在一般人群和动态环境中符合 ISO 81060-2：2018 的要求，因此可以推荐用于临床使用。
