NCT04728477

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 intensive care unit patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 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

January 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

February 3, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

January 24, 2021

Last Update Submit

November 18, 2021

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

  • Comparison of blood pressure between the new smartphone App and the radial arterial line

    Comparative blood pressure measurement with the investigational device and the invasive reference method (arterial line).

    48 hours

Secondary Outcomes (1)

  • Usability assessment

    at 48 hour

Interventions

OPti BP measurementsDEVICE

measurement of blood pressure with the new smartphone App ( OPTIBP)

Eligibility Criteria

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

All intensive care unit patients with an arterial catheter for at least 48 hours

You may qualify if:

  • All Intensive care unit patients with an arterial catheter for at least 48 hours
  • Informed Consent as documented by signature

You may not qualify if:

  • Patients or families that cannot sign informed consent
  • Patients in emergency situation, and unstable
  • Dyshythmia like bigeminy, trigeminy, isolated Ventricular Premature Beats (VPB), atrial fibrillation
  • Lesion or deficiency on hand, preventing index obstruction of smartphone's camera
  • Known contact dermatitis to nickel/chromium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ERASME

Brussels, 1070, Belgium

Location

Related Publications (1)

  • Desebbe O, Anas C, Alexander B, Kouz K, Knebel JF, Schoettker P, Creteur J, Vincent JL, Joosten A. Evaluation of a novel optical smartphone blood pressure application: a method comparison study against invasive arterial blood pressure monitoring in intensive care unit patients. BMC Anesthesiol. 2022 Aug 15;22(1):259. doi: 10.1186/s12871-022-01797-0.

    PMID: 35971072DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Alexandre JOOSTEN, MD PhD

    ERASME

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

January 24, 2021

First Posted

January 28, 2021

Study Start

February 3, 2021

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

November 19, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)