Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04121624
Recruitment Status : Completed
First Posted : October 10, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Alexandre Joosten, MD PhD, Erasme University Hospital

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 )

Condition or disease Intervention/treatment
Technology Device: novel mobile phone application for blood pressure monitoring.

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


Layout table for study information
Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • 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).


Primary Outcome Measures :
  1. 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 )


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Belgium
Erasme
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Alexandre J Joosten, MD PhD ERASME

Layout table for additonal information
Responsible Party: Alexandre Joosten, MD PhD, Principal Investigator, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT04121624     History of Changes
Other Study ID Numbers: P2019/375
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No