Non-Invasive Vital Signs Monitoring (NIVS) Project

NCT ID: NCT05202769

Last Updated: 2022-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-11

Study Completion Date

2023-12-31

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.

Conditions

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Hemodynamic Monitoring Monitoring, Physiologic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Video filming

Intervention Type OTHER

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

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.

Video filming

Intervention Type OTHER

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

Interventions

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Video filming

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

Intervention Type OTHER

Other Intervention Names

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RGB and thermal camera imaging

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Malta

OTHER

Sponsor Role collaborator

Sciberras, Stephen M.D.

INDIV

Sponsor Role lead

Responsible Party

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Stephen Sciberras

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mater Dei Hospital

Msida, , Malta

Site Status RECRUITING

Countries

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Malta

Central Contacts

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Nicole Grech, MD

Role: CONTACT

+35625457234

Facility Contacts

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Stephen Sciberras, MD

Role: primary

0035679070978

Other Identifiers

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NIVS

Identifier Type: -

Identifier Source: org_study_id

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