Accuracy of the RIVA Digital Blood Pressure Measurement App - a Pilot Study
NCT ID: NCT04461834
Last Updated: 2020-10-01
Study Results
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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COMPLETED
50 participants
OBSERVATIONAL
2020-06-25
2020-09-24
Brief Summary
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Detailed Description
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The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the BPM 24 hours after calibration will also be tested.
Before mounting the 24h-Blood Pressure (BP) monitor, a set of 11 BPM will be taken, starting with a conventional BPM using a Welch Allyn Connex® Spot Monitor, then alternating to the app, leading to 6 possible pairs of comparison. The next day, without another calibration of the app, we will take another 3 pairs of comparison (7 alternating measurements, starting with a conventional measurement). Examinators are blinded for the results of the app measurements. The app automatically sends the data of the BPM to RIVA Digital, where the results measured by the app will be processed. The staff of RIVA Digital are blinded to the conventional BPM results.
Number of Participants: 50 consecutive patients will be included in the study.
Statistical analyses: Both BPM procedures are analyzed for correlation and accuracy.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* impossibility to sign informed consent
* physical restrictions to Blood Pressure Measurement
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Mayr, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Basel
Locations
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University Hospital of Basel
Basel, , Switzerland
Countries
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Other Identifiers
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RIVA_Basel
Identifier Type: -
Identifier Source: org_study_id
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