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

Vital Signs Clinical Trial

— VITALPICU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04627766
• Other study ID #: 2021-3157
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: St. Justine's Hospital
• Contact: Philippe Jouvet, MD, PhD
• Phone: 514-345-4931
• Email: philippe.jouvet[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 VT-Patch versus standard of care (Philips monitoring system) for the continuous monitoring of oxygen saturation (SpO2) in PICU patients.

Secondary objectives:

Assess the accuracy of VT-Patch 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. The effect of the skin colour on the vital signs measurements will be investigated as well.

Design:

Prospective validation study of VT-Patch 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 6 children to assess the feasibility of the protocol.

• Main study: validation phase of the device on 2 children per age group per skin phototype (based on Fitzpatrick scale) 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 8 hours with VT-Patch 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 VT-Patch is suitable for pediatric patient monitoring.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: September 30, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Vital Signs

Intervention

Device:
• Monitoring 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

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2	Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded using standard of care	8 hours
Secondary	Heart rate	Percentage of the difference between the absolute value of heart rate recorded by VT-Patch and the one recorded using the standard of care	8 hours
Secondary	Respiratory rate	Percentage of the difference between the absolute value of respiratory rate recorded by VT-Patch and the one recorded using standard of care	8 hours
Secondary	Temperature	Percentage of the difference between the absolute value of temperature recorded by VT-Patch and the one recorded using standard of care	8hours
Secondary	Skin Colour	measurement of skin melanin content by non-invasive spectrometer apparatus	10 minutes