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CompletedNCT04728477Updated Nov 19, 2021

Evaluation of Novel Optical Smartphone Application for Blood Pressure Measurements in Critically Ill Patients

An observational study in Hypotension, sponsored by Erasme University Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-11-19.

Sponsored by Erasme University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 99 Years
Sex
All
01

Study 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

Read the detailed description

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 radial arterial line)

All patients admitted in the intensive care unit at Erasme Hospital Brussels, Belgium will be recruited and if they have an arterial line for at least two days

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 each hour for 5 hours and this will be done for 2 days.

The patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (arterial line).

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 arterial line (gold standard)

02

Conditions studied

  • Hypotension

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03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 30 is below the median of 84 across 294 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • DeviceOPti BP measurements

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

06

What researchers measure

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).

    Time frame: 48 hours

Secondary outcomes

  1. Usability assessment

    Identification of possible use error in the manipulation of the device and in the performance of the measure

    Time frame: at 48 hour

07

Study locations

1 site
  • ERASME
    Brussels, 1070, Belgium
08

References and documents

Publications

  • 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. PubMed 35971072 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04728477
Lead sponsor
Erasme University Hospital
Responsible party
Alexandre Joosten, MD PhD (Study Director, Erasme University Hospital) — Principal investigator
First posted
Jan 28, 2021
Start date
Feb 3, 2021
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021
Last update
Nov 19, 2021

Study contacts

Alexandre JOOSTEN, MD PhD
principal investigator · ERASME

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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