iPhone App Compared to Standard Riva-Rocci (RR)-Measurement During Stress Testing

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Device: cuff device; Device: iphone

• Registration Number: NCT02860533
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Study Start: 2016-09-01
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• able to give informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood pressure measurement	cuff device	six repetitive blood pressure measurements with iPhone and conventional oscillometric cuff device during stress testing will be performed
Blood pressure measurement	iphone	six repetitive blood pressure measurements with iPhone and conventional oscillometric cuff device during stress testing will be performed

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of measurement failures	1 day	Number of measurements that cannot be analyzed due to bad signal quality of the Photoplethysmography (PPG) signal

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, BS, Switzerland