NCT04728477

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

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)

Conditions

• Hypotension

Interventions

Type	Name	Description
DEVICE	OPti BP measurements	measurement of blood pressure with the new smartphone App ( OPTIBP)

Timeline

• Start date: 2021-02-03
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2021-01-28
• Last updated: 2021-11-19

Locations

1 site across 1 country: Belgium