NCT04262323

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

February 5, 2020

Last Update Submit

March 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Confirmation of Blood pressure values measured simultaneously with the novel mobile phone application

    Comparison of values to non-invasive reference method (the oscillometric brachial cuff )

    up to 2 hours

Interventions

Comparative blood pressure measurement with the mobile phone application and the non-invasive reference method (upper arm cuff).

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the surgical department at Erasme hospital for a moderate risk surgery

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Blood Pressure Monitors

Intervention Hierarchy (Ancestors)

SphygmomanometersDiagnostic EquipmentEquipment and Supplies

Study Officials

  • Alexandre Joosten, MD PhD

    ERASME

    STUDY CHAIR

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

February 5, 2020

First Posted

February 10, 2020

Study Start

January 11, 2021

Primary Completion

March 5, 2021

Study Completion

March 5, 2021

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations