Non-Invasive Vital Signs Monitoring (NIVS) Project (NIVS)

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodynamic Monitoring; Monitoring, Physiologic
• Intervention / Treatment: Other: Video filming

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Nicole Grech, MD; Phone Number: +35625457234; Email: nicole.grech@gov.mt

Study Locations

• Malta
  • Imsida, Malta, MSD2090
    • Recruiting
    • Mater Dei Hospital
    • Contact: Stephen Sciberras, MD; Phone Number: 0035679070978; Email: stephen.sciberras@gov.mt
    • Principal Investigator: Stephen Sciberras, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients that fit into the inclusion criteria are included in the study regardless of underlying comorbidities or reasons for admission to the ICU.

Description

Inclusion Criteria:

• age above 18 years and able to provide consent

Exclusion Criteria:

• age under 18 years and known cardiovascular or respiratory diseases

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; 20 healthy volunteers above the age of 18 in a laboratory setting with video clips taken under varying conditions of lighting, distance between the cameras and the participants' faces and with various positions and limb movements involved.	Other: Video filming; Video clips taken using RGB and thermal imaging cameras under varying conditions of lighting, movement and procedures taking place.; Other Names: RGB and thermal camera imaging
ICU patients; Group/Cohort Description: 20 patients above the age of 18 years and able to provide consent, admitted to the ICU with various underlying conditions and comorbidities. Video clips are taken under varying conditions of lighting, positions and with ongoing care and procedures.	Other: Video filming; Video clips taken using RGB and thermal imaging cameras under varying conditions of lighting, movement and procedures taking place.; Other Names: RGB and thermal camera imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Respiratory rate as measured by a camera system	1 day
Heart Rate, as measured by a camera system	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the accuracy of parameters obtained via the camera-based system as compared to the traditional contact monitoring system.	1 day

Collaborators and Investigators

• Sponsor: Sciberras, Stephen M.D.
• Collaborators: University of Malta

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 11, 2022
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (ACTUAL): January 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Non-invasive monitoring; RGB camera; thermal camera
• Other Study ID Numbers: NIVS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No