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

NCT04627766 | Recruiting DMC

• 1 other identifier: 2021-3157
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• SpO2

  Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded using standard of care

  8 hours

Secondary Outcomes (3)

• Heart rate

  8 hours

• Respiratory rate

  8 hours

• Temperature

  8hours

Study Arms (1)

Monitored children

EXPERIMENTAL

PICU Children that will be monitored with the device

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

Interventions

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

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

Monitored children

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte Justin Hospital

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Study Officials

• Philippe Jouvet, MD, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Jouvet, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Monitoring of vital signs with VT-Patch and standard of care

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 13, 2020
• Study Start: February 2, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)