Validation of a Hybrid Blood Pressure Monitor to Replace the Mercury Standard for Validation Studies According to Modified Criteria of the European Society of Hypertension International Protocol 2010
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure Measured by Tested Device.
研究概览
简要总结
Assessment of the accuracy of a Blood Pressure Measuring Device with a digital display-column, NISSEI DM 3000, according to an adaptation of the "European Society of Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure Measuring Devices in Adults".
详细描述
According to the "European Society of Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure Measuring Devices in Adults", 33 patients have their blood pressure measured by two observers using parallel connected mercury sphygmomanometers, blinded from each other's result, and then by the supervisor using the tested device, NISSEI DM 3000. The measurements using the mercury sphygmomanometers are repeated 5 times and in between them, 4 measurements using the tested device take place. If the results of the comparison of these measurements according to the analysis required by the protocol, meet the required criteria, the device is regarded as "Pass", otherwise as "Fail".
In this study, instead of consecutive, simultaneous measurements of the two mercury sphygmomanometers and tha tested device will be taking place. This will be so to exclude any inaccuracy due to blood pressure variability and because the tested device has a controllable deflation rate and allows simultaneous measurements with the mercury sphygmomanometers. In addition, the investigators will be performing 6 set of measurements instead of 4.
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
- None
入排标准
- 年龄范围
- 25 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Above 25 years of age
- •Sinus rhythm
- •Informed consent
排除标准
- •Sustained arrhythmia
- •Pregnancy
- •Poor quality Korotkoff sounds
- •Unavailable cuff size
- •Completed blood pressure range (according to protocol)
结局指标
主要结局
Systolic Blood Pressure Measured by Tested Device.
时间窗: 3 months
Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.
Systolic Blood Pressure Measured With Mercury Sphygmomanometer.
时间窗: 3 months
Mean Systolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.
Diastolic Blood Pressure Measured by Tested Device.
时间窗: 3 months
Mean Diastolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.
Diastolic Blood Pressure Measured With Mercury Sphygmomanometer.
时间窗: 3 months
Mean Diastolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.
次要结局
未报告次要终点
研究者
George S. Stergiou
Associate Professor of Medicine and Hypertension
University of Athens
