Clinical Validation Of The Brachial Blood Pressure Measuring Device Withings BPM Pro 2 According To "The Universal Protocol For The Validation Of Blood Pressure Measuring Devices By The Association For The Advancement Of Medical Instrumentation / European Society Of Hypertension / International Organization For Standardization (AAMI/ESH/ISO) (And Its Amendment 1 (2020) And 2 (2024))" In The General Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Withings
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Blood pressure measurement performance evaluation per measure
研究概览
简要总结
The aim of the study is to assess the accuracy of the automatic oscillometric BP measuring device at the brachial level, the WITHINGS BPM Pro 2, in the general population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient older than 18 years;
- •Patient who signed the informed consent form;
- •Patient followed-up at site (in-patient or out-patient);
- •Patient with arm circumference between 22 cm and 42 cm.
排除标准
- •Patient unable to give a consent or understand properly protocol information;
- •Patient suffering from arrhythmia;
- •Patient with poor quality of Korotkov sounds;
- •Patient for whom K5 sounds are absent;
- •Patient wearing an implantable electric medical device (pacemaker,…);
- •Patient with both upper arms suffering from open wound and/or damaged skin.
研究组 & 干预措施
All patients
Patients consenting to participate to the study and compliant to the inclusion criteria
干预措施: Blood pressure measurement (Device)
结局指标
主要结局
Blood pressure measurement performance evaluation per measure
时间窗: The time frame is three months.
The blood pressure (systolic and diastolic blood pressure) measurement performance will be established using the mean value of the differences and the standard deviation between the device under study and the reference for each measure.
Blood pressure measurement performance evaluation by subject
时间窗: The time frame is three months.
The blood pressure measurement performance by subject will be established using the mean value of the differences and the standard deviation between the averaged per subject value of blood pressure (systolic and diastolic blood pressure) device under study and its reference.
次要结局
- Safety use of the device(The time frame is three months.)