A Novel Mobile Phone Application ( OptiBP) for Blood Pressure Monitoring

Technology Clinical Trial

Official title:

A Novel Mobile Phone Application for Blood Pressure Monitoring: A Comparison With the Oscillometric Brachial Cuff in Surgical Patients in the Postanesthesia Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262323
• Other study ID #: P2020/081
• Status: Completed
• Start date: January 11, 2021
• Est. completion date: March 5, 2021

Study information

• Verified date: March 2021
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of a novel mobile application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) based on collected optical signals on patient's finger treated in surgical patients in the post-anesthesia care unit

Description:

The purpose of the study is to compare the blood pressure values measured by a novel mobile phone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the oscillometric brachial cuff).

All patients scheduled for noncardiac surgery at Erasme Hospital Brussels, Belgium will be recruited and their pressure will be measured with both mesurement methods. (novel smartphone application versus upper arm cuff oscillometry) at 5 time points (each 20-30 minutes)

The OptiBP Application is a mobile application installed on a mobile phone which is a non-invasive data-logger intended to acquire physiological data from patients. By applying the patient's finger on a smartphone's camera, a movie is generated and transformed into values of diastolic, mean and systolic blood pressure.

Three measures will be taken (spaced by one minute) with both methods after a period of 3 minutes of rest at each time point.

The patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (the oscillometric brachial cuff).

Then, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the novel mobile application.

The goal is therefore to compare blood pressure values as obtained by the analysis of the data recorded by the OptiBP Mobile Application, against simultaneous measurements provided by the oscillometric brachial cuff

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients (Men or women) older than 18 years old scheduled for a noncardiac surgery and admiited in the post-anesthesia care unit after the surgery

• Informed Consent as documented by signature (signed before surgery)

Exclusion Criteria:

• Minor patients

• Patients unable to participate due to the illness.

• Patients that cannot sign informed consent

• Blood pressure difference between the two arms of more than10mmHg inter-arm difference)

Related Conditions & MeSH terms

• Technology

Intervention

Device:
• novel mobile phone application for blood pressure monitoring.
Comparative blood pressure measurement with the mobile phone application and the non-invasive reference method (upper arm cuff).

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmation of Blood pressure values measured simultaneously with the novel mobile phone application	Comparison of values to non-invasive reference method (the oscillometric brachial cuff )	up to 2 hours