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Clinical Trials/NCT02860533
NCT02860533CompletedNot Applicable

iPhone App Compared to Standard RR-measurement During Stress Testing

University Hospital, Basel, Switzerland2 sites in 1 country220 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
220
Locations
2
Primary Endpoint
Absolute difference between conventional blood pressure measurements and the corresponding iPhone blood pressure estimations

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

Blood pressure measurement

Experimental

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

Intervention: 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

Intervention: iphone (Device)

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Number of measurement failures(1 day)

Investigators

Sponsor
University Hospital, Basel, Switzerland
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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