Evaluation of a Novel Mobile Phone Application ( OptiBP) for Blood Pressure Monitoring

Technology Clinical Trial

Official title:

A New Mobile Phone Application for Blood Pressure Monitoring: A Comparison With the Oscillometric Brachial Cuff in Patients Treated in The Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121624
• Other study ID #: P2019/375
• Status: Completed
• Start date: October 7, 2019
• Est. completion date: November 8, 2019

Study information

• Verified date: November 2019
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of a novel smartphone application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) and heart rate based on collected optical signals on patient's finger treated in the emergency department against the reference method (the oscillometric brachial cuff )

Description:

The purpose of the study is to compare the blood pressure values measured by a novel smartphone 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 admitted to the emergency department at Erasme Hospital Brussels, Belgium during 5 consecutive weeks will be recruited and their pressure will be measured with both mesurement methods. (novel smartphone application versus upper arm cuff oscillometry).

The OptiBP Application is a mobile application installed on a smartphone 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 (+ heart rate), as well as patient's heart rate.

After having compared that the blood pressure in both arms are similar ( maximum of 10 mmHg of blood pressure difference between both arms), three measures will be taken (spaced by one minute) with both methods after a period of 3 minutes of rest (supine position).

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: 110
• Est. completion date: November 8, 2019
• Est. primary completion date: November 8, 2019
• 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 admitted to the emergency department and in relatively good conditions to be able to participate in the study.

• Informed Consent as documented by signature

Exclusion Criteria:

• Minor patients

• Patients unable to participate due to the illness.

• Patients that cannot sign informed consent

• Patients extremely painful at the arrival (not possible for him to stay in a supine position).

• Blood pressure difference between the two arms >10mmHg

• Unstable patients requiring an urgent management

Related Conditions & MeSH terms

• Technology

Intervention

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

Locations

Country	Name	City	State
Belgium	Erasme	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 simultanuously with the novel smartphone application	Comparision of values to non-invasive reference method (the oscillometric brachial cuff )	during a 6 minutes period of time in the emergency department.
Secondary	Usability assessment	Identification of possible use error in the manipulation of the device and in the performance of the measure (finger position, contact pressure, etc).	during a 6 minutes period of time in the emergency department.