Concordance Between Central Blood PRessure dEvices In Nephrology Patients (CBP-REIN)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Central SBP difference
研究概览
简要总结
The most accurate way to determine intra-aortic BP is to obtain invasive measures by vascular catheterization, which is not possible to perform routinely during the regular follow-up of patients. However, in recent years, devices used to estimate central BP have been designed and approved for clinical use. These devices can determine aortic BP in a non-invasive way using various techniques and algorithms and offer a high degree of precision when compared to invasive measurements of intraaortic BP. On the other hand, certain characteristics specific to the different devices mean that the central BP values obtained may not be interchangeable. It is therefore important to determine the degree of agreement of central BP values obtained using commercially available devices.
This study aims to determine the degree of agreement between central BP measurements obtained using 4 devices commonly used to measure central blood pressure, i.e. Mobil-o-Graph NG (IEM, Germany), WatchBP Office (Microlife, Taiwan), Oscar 2 with SphygmoCor inside (SunTech, USA) and BP+ (Uscom, Australia). These four devices record the shape of the pulsatile wave and then derive the central BP using an algorithm. The main differences between these devices lie in this algorithm, or "transfer function,", which is unique to each and the calibration used. All use a brachial cuff to capture the pulse waveform and can easily be used in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-80 years old
排除标准
- •Ongoing atrial fibrillation
- •Arm circumference incompatible with the blood pressure cuffs for all devices (<18 cm or > 50 cm)
- •Incapacity to give consent
结局指标
主要结局
Central SBP difference
时间窗: at enrollment (time 0)
Differences in the central SBP measured by each device
次要结局
- Brachial SBP difference(at enrollment (time 0))
- Brachial DBP difference(at enrollment (time 0))
- Central DBP difference(at enrollment (time 0))
