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

Hypotension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04728477
• Other study ID #: P2020/665
• Status: Completed
• Start date: February 3, 2021
• Est. completion date: April 1, 2021

Study information

• Verified date: November 2021
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension

Intervention

Device:
• OPti BP measurements
measurement of blood pressure with the new smartphone App ( OPTIBP)

Locations

Country	Name	City	State
Belgium	ERASME	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Usability assessment	Identification of possible use error in the manipulation of the device and in the performance of the measure	at 48 hour