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

ConditionVital Signs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorSt. Justine's Hospital

About this trial

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

Qualifiers

Children (0 to 18 years old) admitted in St. Justine's Hospital's PICU.

PICU monitoring for the next 24 hours

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

48 Participants
are divided into 1 treatment group

Sponsors and collaborators