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

NCT ID: NCT02860533

Last Updated: 2019-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2017-02-01

Brief Summary

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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

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Conditions

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Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Blood pressure measurement

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

Group Type EXPERIMENTAL

cuff device

Intervention Type DEVICE

Measurement of blood pressure during stress testing with cuff device

iphone

Intervention Type DEVICE

Measurement of blood pressure during stress testing with iPhone

Interventions

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cuff device

Measurement of blood pressure during stress testing with cuff device

Intervention Type DEVICE

iphone

Measurement of blood pressure during stress testing with iPhone

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Eckstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2016-00871

Identifier Type: -

Identifier Source: org_study_id

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