Evaluation of a Novel Mobile Phone Application ( OptiBP) for Blood Pressure Monitoring
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|ClinicalTrials.gov Identifier: NCT04121624|
Recruitment Status : Completed
First Posted : October 10, 2019
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment|
|Technology||Device: novel mobile phone application for blood pressure monitoring.|
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
|Study Type :||Observational|
|Actual Enrollment :||110 participants|
|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|
|Actual Study Start Date :||October 7, 2019|
|Actual Primary Completion Date :||November 8, 2019|
|Actual Study Completion Date :||November 8, 2019|
- 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).
- Confirmation of Blood pressure values measured simultanuously with the novel smartphone application [ Time Frame: during a 6 minutes period of time in the emergency department. ]Comparision of values to non-invasive reference method (the oscillometric brachial cuff )
- Usability assessment [ Time Frame: during a 6 minutes period of time in the emergency department. ]Identification of possible use error in the manipulation of the device and in the performance of the measure (finger position, contact pressure, etc).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121624
|Brussels, Belgium, 1070|
|Principal Investigator:||Alexandre J Joosten, MD PhD||ERASME|