RecruitingNot ApplicableNCT04627766

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

Validation of Continuous Monitoring of Vital Signs in Children With VTPatch Connected Device in the Pediatric Intensive Care Unit


Sponsor

St. Justine's Hospital

Enrollment

48 participants

Start Date

Feb 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 0 YearsMax Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria4

  • 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

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Interventions

DEVICEMonitoring 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


Locations(1)

CHU Sainte Justin Hospital

Montreal, Quebec, Canada

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NCT04627766


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