Accuracy of the RIVA Digital Blood Pressure Measurement App - a Pilot Study

Blood Pressure Clinical Trial

Official title:

Accuracy of the RIVA Digital Blood Pressure Measurement App After Initial Calibration and After 24 Hours in a General Population - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04461834
• Other study ID #: RIVA_Basel
• Status: Completed
• Start date: June 25, 2020
• Est. completion date: September 24, 2020

Study information

• Verified date: September 2020
• Source: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 Blood Pressure Measurement 24 hours after calibration will also be tested.

Description:

Conventional blood pressure measurements (BPM) using a cuff-based device are actually gold standard of BPM in clinical practice. Due to availability and patient comfort, the number of such BPM is limited. Considering the large number of people using smartphones, app-based measurements and screening procedures have the potential to increase the availability of BPM and improve blood pressure control, but a prerequisite of the use of these alternative BPM methods is accuracy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 24, 2020
• Est. primary completion date: September 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing a 24h-ambulatory blood pressure measurement

Exclusion Criteria:

• age < 18 years

• impossibility to sign informed consent

• physical restrictions to Blood Pressure Measurement

Related Conditions & MeSH terms

• Blood Pressure

Locations

Country	Name	City	State
Switzerland	University Hospital of Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement	University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data statistical analysis	Both Blood Pressure Measurement procedures are analysed for correlation and accuracy	1 year