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

Study Overview
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Brief Summary
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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 (VTPatch) for the continuous monitoring of vital signs in PICU patients. This monitoring device will be used to monitor children in PICU for 24 hours and results will be compared to the standard of care in the unit that is the Philips monitoring system. The investigators will assess the accuracy of the device 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).

Detailed Description
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Introduction: Patients readmission to PICU is a major point of concern for physician because, although being a rare event, it has been strongly associated to more morbidity and death. Patients monitoring once they have left the PICU is drastically modified and small connected devices could be an option to early identify patients at risk of PICU readmission. Such devices have been manufactured for the monitoring of adults but they do not exist for children. Main objective: Assess the accuracy of VTPatch versus standard of care (Philips monitoring system) for the continuous monitoring of oxygen saturation (SpO2) in PICU patients. Secondary objectives: Assess the accuracy of VTPatch monitoring for 3 additional physiologic parameters (heart rate (HR), respiratory rate (RR) and temperature). Exploratory assessment of blood pressure (BP) monitoring, ECG signal and movement capture. Design: Prospective validation study of VTPatch device for the monitoring of 4 physiologic parameters and exploratory assessment of three additional parameters. Methods: The study will be performed in two successive phases: Run-in phase: testing the device on four children to assess the feasibility of the protocol. Main study: validation phase of the device on 10 children per age groups to assess its accuracy. The patients of the run-in phase will be included in the main study if no modification of the protocol is required. 5 physiologic parameters (HR, SpO2, RR, temperature and BP) and ECG will be prospectively recorded during a 24 hours period with VTPatch and the regular monitoring system implemented in the unit High-resolution database that will be the Gold standard for evaluation. Participating center: 1 center (St. Justine's Hospital). Perspectives: This validation step of the collected data is necessary to validate that VTPatch is suitable for pediatric patient monitoring.

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

Conditions
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Vital Signs

Intervention / Treatment
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* Device: Monitoring with VTPatch (Connected device manufactured by VitalTracer)


Participation Criteria
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Eligibility Criteria
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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 considered inappropriate by the physician or the nurse in charge because of the child's medical condition

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Monitoring of vital signs with VTPatch and standard of care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitored children<br>PICU Children that will be monitored with the device | Device: Monitoring with VTPatch (Connected device manufactured by VitalTracer)<br>* Patients will be monitored for 24 consecutive hours and vital signs will be recorded with VTPatch and with standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SpO2 | Percentage of the difference between the absolute value of SpO2 recorded by VTPatch and the one recorded using standard of care | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Percentage of the difference between the absolute value of heart rate recorded by VTPatch and the one recorded using standard of care | 24 hours | 
| Respiratory rate | Percentage of the difference between the absolute value of respiratory rate recorded by VTPatch and the one recorded using standard of care | 24 hours | 
| Temperature | Percentage of the difference between the absolute value of temperature recorded by VTPatch and the one recorded using standard of care | 24 hours |