- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121624
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Brussels, Belgium, 1070
- Erasme
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Comparision of values to non-invasive reference method (the oscillometric brachial cuff )
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during a 6 minutes period of time in the emergency department.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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during a 6 minutes period of time in the emergency department.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P2019/375
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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