Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Test Device's Blood Pressure of Resting Condition
研究概览
简要总结
According to INTERNATIONAL STANDARD (hereafter ISO) blood pressure (BP) monitor clinical evaluation protocol (ISO 81060-2:2018, Non-invasive sphygmomanometers- Part2: Clinical investigation of intermittent automated measurement type) for BN1 (BNiBP), an electronic sphygmomanometer module newly developed by Bionet Co., Ltd., the clinical group and evaluation criteria presented in, the effectiveness of blood pressure measurement performance was evaluated.
The auscultation method used as a reference (gold standard) of a non-invasive blood pressure (NIBP) measurement method was used. The first blood pressure measurement was performed once each (reference BP not used for evaluation, R0; test BP not used for evaluation, T0) with auscultation and the test medical device (BM5 equipped with BN1 (BNiBP)). The blood pressure used for evaluation was measured four times by auscultation (first reference BP to fourth reference BP, R1 to R4) and three times by the test medical device (first test BP to third test BP, T1 to T3) alternately. A minimum interval of 1 min was allowed between each blood pressure measurement.
Three data pairs (mean value of R1, R2 & T1 / R2, mean value of R3 & T2 / R3, mean value of R4 & T3) were obtained from one study subject. This study aims to verify that the mean value of the differences and standard deviations of data pairs meet the criteria of ISO 81060-2:2018.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
In this study, the protocol applied to automatic electronic blood pressure system module BN1 for performance evaluation is ISO's proposed "ISO 81060-2:2018 Non-invasive sphygmomanometers- Part2: Clinical investment of internal automatic measurement type". The initial BP measurement is performed alternately, measuring the blood pressure by the measurer and the test device once each, and measuring blood pressure by the measurer four times by the observer and three times by the test device.
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recruitment is made through the recruitment notice for patients and their guardians who visit Hanyang University Hospital. Subjects who meet the criteria presented in ISO 81060-2:2018 Protocol 5.1 Subject requirements are recruited.
排除标准
- •Emergency surgery patient
- •Persons who have mental disorders such as mental retardation, autism, etc. and who have difficulty measuring blood pressure or are expected to have difficulties
- •A person who disagreed with the study
结局指标
主要结局
Test Device's Blood Pressure of Resting Condition
时间窗: Right after the experiment
The blood pressure used for evaluation was measured four times by auscultation (first reference BP to fourth reference BP, R1 to R4) and three times by the test medical device (first test BP to third test BP, T1 to T3) alternately. A minimum interval of 1 min was allowed between each BP measurement. Three data pairs (mean value of R1, R2 \& T1 / R2, mean value of R3 \& T2 / R3, mean value of R4 \& T3) were obtained from one study subject. Criterion 1 is that for valid data pairs, the mean value of the difference between the test medical device and the auscultation method BP (test device BP - auscultation BP) should be 5 mmHg or less and the standard deviation (SD) should be 8 mmHg or less. Criterion 2 is that, for study subjects, the ISO 81060-2:2018 for presenting different SD thresholds depending on the mean value of the difference should be satisfied. When mean value of the difference is ±1.6, ±0.0 mmHg, the SD should be less than 6.76 and 6.95 mmHg, respectively.
次要结局
未报告次要终点
研究者
Hoon-Ki Park
Professor
Hanyang University Seoul Hospital