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临床试验/NCT04461834
NCT04461834已完成不适用

Accuracy of the RIVA Digital Blood Pressure Measurement App After Initial Calibration and After 24 Hours in a General Population - a Pilot Study

CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Data statistical analysis

研究概览

简要总结

The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the Blood Pressure Measurement 24 hours after calibration will also be tested.

详细描述

Conventional blood pressure measurements (BPM) using a cuff-based device are actually gold standard of BPM in clinical practice. Due to availability and patient comfort, the number of such BPM is limited. Considering the large number of people using smartphones, app-based measurements and screening procedures have the potential to increase the availability of BPM and improve blood pressure control, but a prerequisite of the use of these alternative BPM methods is accuracy.

The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the BPM 24 hours after calibration will also be tested.

Before mounting the 24h-Blood Pressure (BP) monitor, a set of 11 BPM will be taken, starting with a conventional BPM using a Welch Allyn Connex® Spot Monitor, then alternating to the app, leading to 6 possible pairs of comparison. The next day, without another calibration of the app, we will take another 3 pairs of comparison (7 alternating measurements, starting with a conventional measurement). Examinators are blinded for the results of the app measurements. The app automatically sends the data of the BPM to RIVA Digital, where the results measured by the app will be processed. The staff of RIVA Digital are blinded to the conventional BPM results.

Number of Participants: 50 consecutive patients will be included in the study.

Statistical analyses: Both BPM procedures are analyzed for correlation and accuracy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients undergoing a 24h-ambulatory blood pressure measurement

排除标准

  • age < 18 years
  • impossibility to sign informed consent
  • physical restrictions to Blood Pressure Measurement

结局指标

主要结局

Data statistical analysis

时间窗: 1 year

Both Blood Pressure Measurement procedures are analysed for correlation and accuracy

次要结局

未报告次要终点

研究者

发起方
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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