Clinical trial NCT05202769: Non-Invasive Vital Signs Monitoring (NIVS) Project
Official title: Non-Invasive Vital Signs Monitoring (NIVS) Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodynamic Monitoring
Monitoring, Physiologic
Keywords: Non-invasive monitoring
RGB camera
thermal camera
Lead sponsor: Sciberras, Stephen M.D.
Sponsor class: INDIV
Collaborators: name: University of Malta
First posted: 2022-01-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* age above 18 years and able to provide consent

Exclusion Criteria:

* age under 18 years and known cardiovascular or respiratory diseases

Primary outcomes:
measure: Respiratory rate as measured by a camera system
timeFrame: 1 day
measure: Heart Rate, as measured by a camera system
timeFrame: 1 day
Secondary outcomes:
measure: To assess the accuracy of parameters obtained via the camera-based system as compared to the traditional contact monitoring system.
timeFrame: 1 day
Other outcomes:
Locations:
city: Imsida
country: Malta
facility: Mater Dei Hospital
Study officials:
References: