Non-Invasive Vital Signs Monitoring (NIVS) Project

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemodynamic Monitoring, Monitoring, Physiologic

Intervention / Treatment
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* Other: Video filming


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age above 18 years and able to provide consent Exclusion Criteria: age under 18 years and known cardiovascular or respiratory diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>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<br>* Video clips taken using RGB and thermal imaging cameras under varying conditions of lighting, movement and procedures taking place.<br>* Other names: RGB and thermal camera imaging;|
| ICU patients<br>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<br>* Video clips taken using RGB and thermal imaging cameras under varying conditions of lighting, movement and procedures taking place.<br>* Other names: RGB and thermal camera imaging;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thermal camera, Non-invasive monitoring, RGB camera