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Status unknownNCT05202769NIVSUpdated Oct 27, 2022

Non-Invasive Vital Signs Monitoring (NIVS) Project

An observational study in Hemodynamic Monitoring and Monitoring, Physiologic, sponsored by Sciberras, Stephen M.D.. Status unknown at 1 site in Malta. Open to participants aged 18 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-27.

Sponsored by Sciberras, Stephen M.D. · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 95 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Hemodynamic Monitoring
  • Monitoring, Physiologic

Keywords

  • Non-invasive monitoring
  • RGB camera
  • thermal camera
03

In context

Lead sponsor

Sciberras, Stephen M.D. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age above 18 years and able to provide consent

Exclusion criteria

Exclusion Criteria:

  • age under 18 years and known cardiovascular or respiratory diseases
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherVideo filming

    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

06

What researchers measure

Primary outcomes

  1. Respiratory rate as measured by a camera system

    Time frame: 1 day

  2. Heart Rate, as measured by a camera system

    Time frame: 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.

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Mater Dei Hospital
    Imsida, MSD2090, Malta
    Recruiting
    • Stephen Sciberras, MD · Contactstephen.sciberras@gov.mt · 0035679070978
    • Stephen Sciberras, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05202769
Lead sponsor
Sciberras, Stephen M.D.
Collaborators
University of Malta
Responsible party
Stephen Sciberras (Primary Investigator, Sciberras, Stephen M.D.) — Principal investigator
First posted
Jan 21, 2022
Start date
Feb 11, 2022
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Oct 27, 2022

Study contacts

Nicole Grech, MD
Contact
nicole.grech@gov.mt
+35625457234

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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