ChiCTR-DOD-16009648进行中(未招募)不适用
基于国际标准的攀高自动血压计准确性测试
深圳攀高电子有限公司1 个研究点 分布在 1 个国家开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 试验地点
- 1
- 主要终点
- 血压
研究概览
简要总结
依据欧洲高血压协会国际评估方案、英国高血压协会评估方案、AAMI/ISO 方案(EN 1060)等标准评价攀高全自动电子血压计准确性
研究设计
- 研究类型
- 诊断试验
- 主要目的
- 诊断试验诊断准确性
- 盲法
- 两位观察者之间相互设盲,并对设备测量值设盲。
入排标准
- 年龄范围
- 18 至 90(—)
- 性别
- All
入选标准
- •性别:男女基本均衡; 年龄范围:25 岁以上(ESH)或者成年人 / 儿童(按照标准纳入); 心律:窦性心律; 血压范围:根据研究方案确定的收缩压与舒张压范围纳入的受试者符合方案要求。
排除标准
- •血压范围纳入完毕;范围调整;心律失常(不齐);设备故障;听诊声音质量差;无合适袖带;观测值分歧;血压分布;与其它需要排除的情况。
结局指标
主要结局
血压
次要结局
未报告次要终点
研究者
研究点 (1)
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