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

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ClinicalTrials.gov Identifier: NCT04728477
Recruitment Status : Completed
First Posted : January 28, 2021
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
Alexandre Joosten, MD PhD, Erasme University Hospital

Study Description
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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

Condition or disease Intervention/treatment
Hypotension Device: OPti BP measurements

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)

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy, Precision and Trending Abilities of Novel Optical Smartphone Application for Blood Pressure Measurements in Critically Ill Patients: A Method Comparison Study Against the Arterial Line as the Reference Method
Actual Study Start Date : February 3, 2021
Actual Primary Completion Date : April 1, 2021
Actual Study Completion Date : April 1, 2021
Groups and Cohorts
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Intervention Details:
  • Device: OPti BP measurements
    measurement of blood pressure with the new smartphone App ( OPTIBP)

Outcome Measures
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Primary Outcome Measures :
  1. Comparison of blood pressure between the new smartphone App and the radial arterial line [ Time Frame: 48 hours ]
    Comparative blood pressure measurement with the investigational device and the invasive reference method (arterial line).


Secondary Outcome Measures :
  1. Usability assessment [ Time Frame: at 48 hour ]
    Identification of possible use error in the manipulation of the device and in the performance of the measure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

Inclusion Criteria:

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728477


Locations
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Belgium
ERASME
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
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Principal Investigator: Alexandre JOOSTEN, MD PhD ERASME
More Information
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Responsible Party: Alexandre Joosten, MD PhD, Study Director, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT04728477    
Other Study ID Numbers: P2020/665
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases