Non-Invasive Vital Signs Monitoring (NIVS) Project

NCT05202769 | Unknown DMC

• 1 other identifier: NIVS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodynamic Monitoring; Monitoring, Physiologic

Keywords

Non-invasive monitoring; RGB camera; thermal camera

Outcome Measures

Primary Outcomes (2)

• Respiratory rate as measured by a camera system

  1 day

• Heart Rate, as measured by a camera system

  1 day

Secondary Outcomes (1)

• To assess the accuracy of parameters obtained via the camera-based system as compared to the traditional contact monitoring system.

  1 day

Study Arms (2)

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

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

Interventions

Video filming OTHER

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

Also known as: RGB and thermal camera imaging

Healthy Volunteers; ICU patients

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age above 18 years and able to provide consent

You may not qualify if:

• age under 18 years and known cardiovascular or respiratory diseases

Sponsors & Collaborators

• Sciberras, Stephen M.D.: lead
• University of Malta: collaborator

Study Sites (1)

Mater Dei Hospital

Msida, MSD2090, Malta

RECRUITING

Central Study Contacts

Nicole Grech, MD

CONTACT

+35625457234; nicole.grech@gov.mt

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 21, 2022
• Study Start: February 11, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

MA (1)