NCT00265707Unknown不适用
A Study to Evaluate the Safety and Effectiveness (Overall Performance) of the Press-O-Sense Non-Invasive Blood Pressure Measuring Device.
Maaynei Hayesha Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2005年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The difference between the paired measurements with the tested device and the reference measurements (with a mercury sphygmomanometer) will differ by no more than +-5mmHg.
研究概览
简要总结
- A disposable blood pressure measuring device will be tested and compared to a standard mercury sphygmomanometer.
- Up to 100 subjects with various levels of blood pressure values will be tested.
详细描述
The study will comprise 85 to 100 subjects with blood pressure values ranging between 90 and 170mmHg -systolic and 65-95 -diastolic.
- Three sets of measurements will be performed on each subject. The measurement with the tested device placed between twh determinations with a mercury sphygmomanometer.
- Each measurement will be performed simultaneously by two examiners specially trained.
- Informed consent will be obtained from all participants.
- The results will be evaluated by a standard statistical plan ANSI/AAMI SP-10 2002.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 years or above
- •Signed written informed consent
排除标准
- •A history of cardiac arrythmia
- •Wrist circumference smaller than 13cm or larger than 19.5cm
- •Documented peripheral vascular disease
- •Damage or injury to the left wrist
- •Participation in any other clinical study
- •Any acute coronary of cardiovascular illness
结局指标
主要结局
The difference between the paired measurements with the tested device and the reference measurements (with a mercury sphygmomanometer) will differ by no more than +-5mmHg.
次要结局
未报告次要终点
研究者
研究点 (1)
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