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

NCT ID: NCT04121624

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-07

Study Completion Date

2019-11-08

Brief Summary

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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

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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

Conditions

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Technology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alexandre Joosten, MD PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandre J Joosten, MD PhD

Role: PRINCIPAL_INVESTIGATOR

ERASME

Locations

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Erasme

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 34409513 (View on PubMed)

Other Identifiers

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P2019/375

Identifier Type: -

Identifier Source: org_study_id

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