Recruiting

Observational Study

Sponsor:

St. Justine's Hospital

Code:

NCT04627766

Conditions

Vital Signs

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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

Study ID

NCT04627766

Start date

Feb 2, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children (0 to 18 years old) admitted in St. Justine's Hospital's PICU.
  • PICU monitoring for the next 24 hours

Exclusion Criteria:

  • Recent cardiac or thoracic surgery
  • Thoracic skin lesion that contraindicates the VT-Patch
  • No parental consent
  • Intermittent presence of one study observer in the patient room is considered inappropriate by the physician or the nurse in charge because of the child's medical condition

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Monitored children

PICU Children that will be monitored with the device

Interventions

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

Primary outcome measure

  • SpO2 [ Time Frame: 8 hours ]

Central Contacts and Locations

Central contacts

Philippe Jouvet, MD, PhD

514-345-4931philippe.jouvet@umontreal.ca

Locations

CHU Sainte Justin Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1C5

More Information

Sponsor

St. Justine's Hospital

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Keywords

  • Pediatrics
  • All-in-One
  • Wireless
  • Pateint remote monitoring
  • SpO2
  • Pulse oximeter
  • Skin Colour
  • VT-Patch

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2025-12-18.