Clinical Trial on the Effectiveness of Blood Pressure Function of Wrist Blood Pressure Monitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- mean difference of systolic blood pressure
研究概览
简要总结
The accuracy and safety of wrist blood pressure (model: MLY-B10) is evaluated according to the requirement of EN ISO 81060-2:2019/A1:2020.
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
- •Subjects should voluntarily participate in the clinical trial and sign the informed consent form.
- •Subjects must be willing and able to follow the investigation procedures.
- •Subjects are over 18 years old whose wrist circumference should be within 13.0-20.0 cm.
排除标准
- •Subjects with serious arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, borderline tachycardia, sinus arrest, pathological sinus syndrome, pacemaker rhythm) showed by electrocardiogram during screening period.
- •Subject with prior allergy to nylon, fluororubber, thermoplastic polyurethane elastomer (TPU), or polyvinyl chloride (PVC) materials.
- •Subjects with prior arterial obstructive disease or arteritis.
- •Subjects who had previously undergone mastectomy.
- •Subjects with wound or wrist inflammation were measured.
- •Subjects who are receiving intravenous infusion, blood transfusion, or other catheters at the site of measurement.
- •Subjects who had eaten, drank, smoked or exercised vigorously in the 30 minutes prior to the study.
- •Subjects who have participated in other clinical trials within 30 days that may affect this trial.
- •Subjects who the investigator consider inappropriate to attend the trial.
结局指标
主要结局
mean difference of systolic blood pressure
时间窗: 30 minutes
mean difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer
standard deviation of the difference of diastolic blood pressure
时间窗: 30 minutes
standard deviation of the difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer
mean difference of diastolic blood pressure
时间窗: 30 minutes
mean difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer
standard deviation of the difference of systolic blood pressure
时间窗: 30 minutes
standard deviation of the difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer
次要结局
未报告次要终点