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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05202769
Other study ID # NIVS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 11, 2022
Est. completion date December 31, 2023

Study information

Verified date October 2022
Source Sciberras, Stephen M.D.
Contact Nicole Grech, MD
Phone +35625457234
Email nicole.grech@gov.mt
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is aimed at non-invasive extraction of cardiovascular and respiratory parameters from red-green-blue (RGB) and thermal imaging cameras from patients in the intensive care unit (ICU) setting. The main focus of this study is in assessing the feasibility of implementing such a camera-based system for prolonged monitoring of patients, identifying limiting factors which may interfere with accuracy or practical aspects of the system, and postulating solutions to overcoming these.


Description:

Non-invasive monitoring of vital signs is an area that is gaining increasing popularity in clinical practise due to its advantages of increased comfort to patients and reduced risk of transmission of multidrug resistant organisms. This study aims to assess the feasibility of using RGB cameras and thermal imaging cameras for monitoring of heart rate and rhythm and respiratory rate and rhythm in the intensive care setting. Videos of patients are taken in the ICU of a Maltese University-affiliated tertiary hospital (Mater Dei Hospital) under varying conditions, including varying light intensity, different patient positions and periods of time where clinical staff are performing regular care tasks and minor interventions such as bloodletting. Patients enrolled will be able to provide consent for the study after being given a detailed explanation of the study aims, data collected, data storage and processing and any other information they may wish to know. The video data will be analysed via a convolutional neural network which has been previously trained to extract cardiovascular and respiratory parameters from videos taken from healthy volunteers in a non-clinical setting (a laboratory located in the University of Malta). The heart rate and respiratory rate extracted from patient videos are then compared to ground truth data obtained by current gold standard contact monitoring (data collected from Phillips Intellivue monitors used throughout the ICU) and assessed for accuracy. The practicality of setting up a camera-based system in the intensive care setting and potential means of overcoming limitations faced will also be tackled in this study from a qualitative aspect.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria: - age above 18 years and able to provide consent Exclusion Criteria: - age under 18 years and known cardiovascular or respiratory diseases

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Video filming
Video clips taken using RGB and thermal imaging cameras under varying conditions of lighting, movement and procedures taking place.

Locations

Country Name City State
Malta Mater Dei Hospital Imsida

Sponsors (2)

Lead Sponsor Collaborator
Sciberras, Stephen M.D. University of Malta

Country where clinical trial is conducted

Malta, 

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory rate as measured by a camera system 1 day
Primary Heart Rate, as measured by a camera system 1 day
Secondary To assess the accuracy of parameters obtained via the camera-based system as compared to the traditional contact monitoring system. 1 day
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