NCT06457568招募中不适用
Validation of the CONTEC08C Oscillometric Blood Pressure Monitor in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)
Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 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 assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in the general population for clinical use 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 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 12 to 79 years
- •Subjects voluntarily participate in the clinical trial and sign the informed consent.
排除标准
- •Subjects with cardiac arrhythmias;
- •Pregnancy;
- •Poor quality Korotkoff sounds;
- •Subject with an arm injury incompatible with the use of a cuff-based sphygmomanometer;
- •Other conditions that the investigator considers ineligible for clinical trial.
结局指标
主要结局
Blood pressure measurement data
时间窗: 30mintues
Systolic Blood Pressure and Diastolic Blood Pressure
次要结局
未报告次要终点
研究者
Lou ying
MD
Chinese Academy of Medical Sciences, Fuwai Hospital
研究点 (1)
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