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OpenTrials
Completed

NCT Number: NCT04728477

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

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

Completed

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ERASME

Brussels, 1070, Belgium

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPti BP measurements

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2021
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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