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

NCT04627766 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-18

No results posted yet for this study

Summary

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

  • Vital Signs

Interventions

DEVICE

Monitoring with VT-Patch (Connected device manufactured by VitalTracer)

Patients will be monitored for 8 consecutive hours and vital signs will be recorded with VT-Patch and with the standard of care

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Philippe Jouvet, MD, PhD · St. Justine's Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-02
Primary Completion
2026-10-01
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04627766 on ClinicalTrials.gov