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

Study acronym: VITALPICU
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 18, 2025 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Oct 1, 2025 to Oct 1, 2026
    • Primary endpoints: 2 to 1
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v5
  2. Trial status: Not Yet Recruiting to Recruitingv4 Show 7 more changesShow less
    • Start date changed from estimate of Mar 1, 2024 to Feb 2, 2025
    • Primary endpoints: 1 to 2
    • Study sites: 0 to 1
    • Primary completion date: Aug 1, 2025 to Oct 1, 2025
    • Study completion date: Sep 30, 2025 to Dec 31, 2025
    • Secondary endpoints: 4 to 3
    • Study description expanded, about 77 words
  3. Primary completion date: Jun 30, 2021 to Aug 1, 2025v3 Show 7 more changesShow less
    • Start date: Feb 1, 2021 to Mar 1, 2024
    • Enrollment target: 40 to 48
    • Study completion date: Jul 31, 2021 to Sep 30, 2025
    • Interventions: Monitoring with VTPatch (Connected device manufactured by VitalTracer) (Device) to Monitoring with VT-Patch (Connected device manufactured by VitalTracer) (Device)
    • Eligibility criteria revised
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 21 words
  4. Study Status, Study Descriptionv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04627766
Lead Sponsor St. Justine's Hospital
Conditions
(from sponsor)		 Vital Signs
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov