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临床试验/NCT05963880
NCT05963880终止不适用

Concordance Between Central Blood PRessure dEvices In Nephrology Patients (CBP-REIN)

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal2 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2021年4月26日最近更新:
适应症

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

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))

研究者

发起方
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
申办方类型
Other
责任方
Sponsor

研究点 (2)

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