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

Blood Pressure Clinical Trial

— iPARRDeltaBP  

Official title:

iPhone App Compared to Standard RR-measurement During Stress Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860533
• Other study ID #: 2016-00871
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: February 1, 2017

Study information

• Verified date: May 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• cuff device
Measurement of blood pressure during stress testing with cuff device
• iphone
Measurement of blood pressure during stress testing with iPhone

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute difference between conventional blood pressure measurements and the corresponding iPhone blood pressure estimations	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	1 day
Secondary	Number of measurement failures	Number of measurements that cannot be analyzed due to bad signal quality of the Photoplethysmography (PPG) signal	1 day