A Novel Mobile Phone Application ( OptiBP) for Blood Pressure Monitoring

NCT ID: NCT04262323

Last Updated: 2021-03-09

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

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-11

Study Completion Date

2021-03-05

Brief Summary

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Evaluation of a novel mobile application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) based on collected optical signals on patient's finger treated in surgical patients in the post-anesthesia care unit

Detailed Description

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The purpose of the study is to compare the blood pressure values measured by a novel mobile phone 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 scheduled for noncardiac surgery at Erasme Hospital Brussels, Belgium will be recruited and their pressure will be measured with both mesurement methods. (novel smartphone application versus upper arm cuff oscillometry) at 5 time points (each 20-30 minutes)

The OptiBP Application is a mobile application installed on a mobile phone 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.

Three measures will be taken (spaced by one minute) with both methods after a period of 3 minutes of rest at each time point.

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 mobile phone 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 scheduled for a noncardiac surgery and admiited in the post-anesthesia care unit after the surgery
* Informed Consent as documented by signature (signed before surgery)

Exclusion Criteria

* Minor patients
* Patients unable to participate due to the illness.
* Patients that cannot sign informed consent
* Blood pressure difference between the two arms of more than10mmHg inter-arm difference)
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 Joosten, MD PhD

Role: STUDY_CHAIR

ERASME

Locations

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Erasme Hospital

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Desebbe O, El Hilali M, Kouz K, Alexander B, Karam L, Chirnoaga D, Knebel JF, Degott J, Schoettker P, Michard F, Saugel B, Vincent JL, Joosten A. Evaluation of a new smartphone optical blood pressure application (OptiBP) in the post-anesthesia care unit: a method comparison study against the non-invasive automatic oscillometric brachial cuff as the reference method. J Clin Monit Comput. 2022 Oct;36(5):1525-1533. doi: 10.1007/s10877-021-00795-w. Epub 2022 Jan 3.

Reference Type DERIVED
PMID: 34978654 (View on PubMed)

Other Identifiers

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P2020/081

Identifier Type: -

Identifier Source: org_study_id

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