Non-Invasive Vital Signs Monitoring (NIVS) Project

Hemodynamic Monitoring Clinical Trial

— NIVS  

Official title:

Non-Invasive Vital Signs Monitoring (NIVS) Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05202769
• Other study ID #: NIVS
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Hemodynamic Monitoring
• Monitoring, Physiologic

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