Validation of the YuWell YE900 Medical Electronic Blood Pressure Monitor in Adults and Children According to the AAMI/ESH/ISO 81060-2:2018 Standard
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Blood pressure measurement data
研究概览
简要总结
The purpose of this study is to evaluate the accuracy of the YuWell YE900 medical electronic blood pressure monitor for blood pressure measurements in adults and children according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (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
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
- •3 Years and older (Child, Adult, Older Adult);
- •Subjects voluntarily participate in the clinical trial and sign the informed consent.
排除标准
- •Disturbance of consciousness;
- •Patients requiring hemodialysis;
- •Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases;
- •Pregnant and lactating women;
- •Patients with cardiac arrhythmias;
- •Other conditions that the investigator considers ineligible for clinical trial.
研究组 & 干预措施
YuWell YE900 and mercury sphygmomanometer
Blood Pressure Measurement with the YuWell YE900 Electronic Sphygmomanometer (YuWell YE900) and with Desk Mercury Sphygmomanometer.
干预措施: YuWell YE900 Electronic Sphygmomanometer (Diagnostic Test)
结局指标
主要结局
Blood pressure measurement data
时间窗: 30 minutes
Systolic Pressure and Diastolic Pressure
次要结局
未报告次要终点
研究者
zhang Hui Jie
Director of Clinical trial center
The Second Hospital of Nanjing Medical University