Clinical trial NCT04121624: Evaluation of a Novel Mobile Phone Application ( OptiBP) for Blood Pressure Monitoring
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Technology
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the Emergency department at Erasme hospital during one month (October 7 th until November 7 th 2019)

Brief 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 )

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Confirmation of Blood pressure values measured simultanuously with the novel smartphone application
timeFrame: during a 6 minutes period of time in the emergency department.
Secondary outcomes:
measure: Usability assessment
timeFrame: during a 6 minutes period of time in the emergency department.
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme
Study officials:
affiliation: ERASME
name: Alexandre J Joosten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Desebbe O, Tighenifi A, Jacobs A, Toubal L, Zekhini Y, Chirnoaga D, Collange V, Alexander B, Knebel JF, Schoettker P, Joosten A. Evaluation of a novel mobile phone application for blood pressure monitoring: a proof of concept study. J Clin Monit Comput. 2022 Aug;36(4):1147-1153. doi: 10.1007/s10877-021-00749-2. Epub 2021 Aug 18.