NCT04627766 Validation of Continuous Monitoring of Vital Signs in Children With a Connected Patch
| NCT ID | NCT04627766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Justine's Hospital |
| Condition | Vital Signs |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-02-02 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-02-02 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Philippe Jouvet, MD, PhD
PRINCIPAL INVESTIGATOR
St. Justine's Hospital
Frequently Asked Questions
Who can join the NCT04627766 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 18 Years, studying Vital Signs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04627766 currently recruiting?
Yes, NCT04627766 is actively recruiting participants. Contact the research team at philippe.jouvet@umontreal.ca for enrollment information.
Where is the NCT04627766 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT04627766 clinical trial?
NCT04627766 is sponsored by St. Justine's Hospital. The principal investigator is Philippe Jouvet, MD, PhD at St. Justine's Hospital. The trial plans to enroll 48 participants.