NCT07595016招募中不适用
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 Pregnancy And Pre-Eclampsia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Withings
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Blood pressure measurement performace 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 pregnancy and pre-eclampsia
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
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;
- •Known pregnancy, in second or third trimester of pregnancy ( > 3 months);
- •Patient normotensive, hypertensive or in preeclampsia;
- •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
Experimental
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 performace evaluation per measure
时间窗: 5 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.
次要结局
未报告次要终点
研究者
研究点 (1)
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