Validation of the YuWell YE660D Oscillometric Upper-arm Blood Pressure Monitor for Clinic and Home in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)
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 YE660D oscillometric upper-arm blood pressure monitor for clinic and home in general population 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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •12 Years and older;
- •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 YE660D and mercury sphygmomanometer
Blood Pressure Measurement with the YuWell YE660D Electronic Sphygmomanometer (YuWell YE660D) and with Desk Mercury Sphygmomanometer.
干预措施: YuWell YE660D 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