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临床试验/NCT02860533
NCT02860533已完成不适用

iPhone App Compared to Standard RR-measurement During Stress Testing

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
220
试验地点
2
主要终点
Absolute difference between conventional blood pressure measurements and the corresponding iPhone blood pressure estimations

研究概览

简要总结

The iPARR DELTA BP Study is designed to evaluate whether a new smartphone app using the photoplethysmography signal of the inbuilt camera can measure blood pressure (BP) fluctuations with sufficient correlation compared to the goldstandard oscillometric BP measurements. Investigators will recruit patients who are scheduled for a routine treadmill stress test and assess their blood pressure before and right after the test with the smartphone app and the standard BP measurements on the opposite upper extremity. Pronounced BP fluctuations are encountered during vigorous activities. The primary endpoint of the iPARR DELTA BP Study is the correlation of the absolute difference of subsequent measurements between both techniques. If the relative chances of BP fluctuations are sufficiently assessed with this new device, BP fluctuations could be monitored continuously after calibration.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • able to give informed consent

排除标准

  • atrial fibrillation
  • medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)

研究组 & 干预措施

Blood pressure measurement

Experimental

six repetitive blood pressure measurements with iPhone and conventional oscillometric cuff device during stress testing will be performed

干预措施: cuff device (Device)

Blood pressure measurement

Experimental

six repetitive blood pressure measurements with iPhone and conventional oscillometric cuff device during stress testing will be performed

干预措施: iphone (Device)

结局指标

主要结局

Absolute difference between conventional blood pressure measurements and the corresponding iPhone blood pressure estimations

时间窗: 1 day

Difference between the delta of two sequential oscillometric measurements and the delta of the two corresponding blood pressure estimates calculated from the PPG signal of an iPhone 4S

次要结局

  • Number of measurement failures(1 day)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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