Actively Recruiting

Phase Not Applicable
Age: 0Years - 18Years
All Genders
NCT04627766

Validation of Continuous Monitoring of Vital Signs in Children With a Connected Patch

Led by St. Justine's Hospital · Updated on 2025-12-18

48

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Small connected devices monitoring vital signs do not exist in children although they could be very useful to monitor patients once they have left the pediatric intensive care unit (PICU) in order to early identify patients at risk of PICU readmission. The main objective of this study is to assess the accuracy of a connected thoracic patch (VT-Patch) for the continuous monitoring of vital signs in PICU patients. This monitoring device will be used to monitor children in PICU for 8 hours and results will be compared to the standard of care in the unit which is the Philips monitoring system. The investigators will assess the device's accuracy for the monitoring of 4 vital signs (SpO2, heart rate, respiratory rate and temperature) and perform exploratory assessment of three additional parameters (EKG, blood pressure and movement capture). The skin colour of each participant will be categorized based on Fitzpatrick scale and non-invasive spectroscopic method.

CONDITIONS

Official Title

Validation of Continuous Monitoring of Vital Signs in Children With a Connected Patch

Who Can Participate

Age: 0Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 0 to 18 years admitted to St. Justine's Hospital PICU
  • Expected PICU monitoring for at least the next 24 hours
Not Eligible

You will not qualify if you...

  • Recent cardiac or thoracic surgery
  • Thoracic skin lesions that prevent the use of VT-Patch
  • Lack of parental consent
  • Physician or nurse considers intermittent presence of study observer inappropriate due to child's medical condition

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Sainte Justin Hospital

Montreal, Quebec, Canada, H3T 1C5

Actively Recruiting

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Research Team

P

Philippe Jouvet, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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