Evaluation of a Novel Mobile Phone Application ( OptiBP) for Blood Pressure Monitoring
A New Mobile Phone Application for Blood Pressure Monitoring: A Comparison With the Oscillometric Brachial Cuff in Patients Treated in The Emergency Department
1 other identifier
observational
110
1 country
1
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 )
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2019
CompletedStudy Start
First participant enrolled
October 7, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2019
CompletedNovember 13, 2019
November 1, 2019
1 month
October 3, 2019
November 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Usability assessment
during a 6 minutes period of time in the emergency department.
Interventions
Comparative blood pressure measurement with the smartphone application and the non-invasive reference method (upper arm cuff).
Eligibility Criteria
Patients admitted to the Emergency department at Erasme hospital during one month (October 7 th until November 7 th 2019)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasme
Brussels, 1070, Belgium
Related Publications (1)
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.
PMID: 34409513DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre J Joosten, MD PhD
ERASME
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 3, 2019
First Posted
October 10, 2019
Study Start
October 7, 2019
Primary Completion
November 8, 2019
Study Completion
November 8, 2019
Last Updated
November 13, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share