Accuracy of the COMBEI BP118A Device for Self-Blood Pressure Measurements in General Population - Validation According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.
Accuracy of the COMBEI BP118A Device for Self-Blood Pressure Measurements in General Population - Validation According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.
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DOI：
10.2147/vhrm.s353715
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发表时间：
2022
影响因子：
2.9
通讯作者：
Asmar R
中科院分区：
文献类型：
--
作者：
Tasić N;Topouchian J;Tasic D;Kovacevic Z;Filipovic M;Asmar R
用于血压（BP）测量的电子设备必须按照各权威机构和科学协会的建议进行独立的临床验证。根据通用标准确认方案，评估Combei BP 118 A器械在一般人群中的准确度。新开发的Combei BP 118 A设备使用血压计法在肱动脉水平测量血压。本研究根据“AAMI/ESH/ISO通用标准（ISO 81060-2：2018）方案”进行。招募受试者（n = 88），根据方案要求，使用同臂序贯BP测量方法，满足年龄、性别、BP和袖带分布标准。计算观察者的水银血压计参考测量值和设备BP值（测试与参考）之间的差异及其标准差（SD）。共入选91例受试者，其中88例入选。同时观察者的参考测量值之间的平均血压差异为收缩压（SBP）为−0.2 ± 1.7 mmHg，舒张压（DBP）为−0.2 ± 1.7 mmHg。对于确认标准1，SBP和DBP的参考和器械BP值之间的平均差± SD分别为3.6 ± 5.5 mmHg和1.4 ± 4.5 mmHg。对于标准2，对于SBP/DBP（≤5.9/6.8），每例受试者的试验器械和参考血压之间的平均血压差异的SD为5/4.1 mmHg。这些结果符合方案要求。用于家庭BP测量的Combei BP 118 A血压计设备符合AAMI/ESH/ISO通用标准（ISO 81060-2：2018）在一般人群中的所有要求，因此可以推荐用于家庭BP测量。
Electronic devices for blood pressure (BP) measurements must undergo independent clinical validation as recommended by various authorities and scientific societies. To assess the accuracy of the Combei BP118A device in the general population according to the Universal Standard Validation Protocol. The new-developed Combei BP118A device measures BP at the brachial level using the oscillometric method. The study was performed according to the “AAMI/ESH/ISO Universal Standard (ISO 81060–2:2018) protocol”. Subjects (n = 88) were recruited to fulfill the age, gender, BP and cuff distribution criteria according to the protocol requirements using the same arm sequential BP measurement method. Differences between observers’ mercury sphygmomanometer reference measurements and device BP values (test versus reference) and their standard deviation (SD) were calculated. Ninety-one subjects were selected, 88 of whom were included. The mean BP differences between the simultaneous observers’ reference measurements were −0.2 ± 1.7 mmHg for systolic BP (SBP) and −0.2 ± 1.7 mmHg for diastolic BP (DBP). For validation criterion 1, the mean difference ± SD between the reference and device BP values were 3.6 ± 5.5 mmHg for SBP and 1.4 ± 4.5 mmHg for DBP. For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5/4.1 mmHg for SBP/DBP (≤5.9/6.8). These results fulfilled the protocol requirements. The Combei BP118A oscillometric device for home BP measurement fulfilled all of the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060–2:2018) in general population and consequently can be recommended for home BP measurements.