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NCT Number: NCT05451875

Validation of Vital Signs Recording With VT-Patch Connected Devices in Children

: Patient readmission to PICU is a major point of concern for physicians because, although being a rare event, it has been strongly associated with more morbidity and death. Patient 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 recording of vital signs in adults, but they do not exist for children.

Besides, studies have recently shown that devices that use optical sensors may be less accurate in individuals with dark skin pigmentation since dark skin tones impose a limitation on optical biometric sensing. The wearable and medical device industry has not sufficiently addressed this issue yet. This is one of the main challenges that need to be addressed in this area to make sure the connected devices using this technology will work with all different skin colours including very dark skin.

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Key information

Conditions

Vital Signs Children Heart Rate Intensive Care Unit Oxygen Saturation Respiratory Rate

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Main objective: Assess the accuracy of VT-Patch® to measure oxygen saturation (SpO2) in children with diverse skin colour.

Secondary objectives: Assess the accuracy of VT-Patch® to measure 3 additional physiologic parameters (heart rate (HR), respiratory rate (RR), and temperature. Exploratory assessment of blood pressure (BP) measurement, ECG signal, and movement capture.

Design: Prospective validation study of VT-Patch® for the recording 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 VT-Patch® on four children to assess the feasibility of the protocol.

Main study: validation phase of the devices on 12 children per age group (2 children per skin colour group) to assess its accuracy (VT-Patch® for less than 2 years old). 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 ECG) will be prospectively and simultaneously recorded for 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. Vital signs recorded with the connected device will not be used for the clinical care of patients. The Skin colour of each patient will be assessed by the colorimetric Monk scale and as shown below.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Non-invasive monitoring

Device

Comparison of VitalTracer monitoring devices with invasive and/or non-invasive gold standard reference

Primary outcomes

  1. Accuracy of VitalTracer devices Oxygen Saturation (SPO2) measurement for different skin colour

    Time frame: 8 hours per subject

    Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded in high resolution database.

Secondary outcomes

  1. Accuracy of VitalTracer devices blood pressure, heart rate, skin temperature, and Electrocardiogram (ECG) measurement

    Time frame: 8 hours per subject

    Percentage of the difference between the absolute value of Blood Pressure, Heart Rate and skin temperature and the quality of ECG signals recorded by the VT-Patch and the one recorded in high resolution database.

Study contacts

Contact information is provided by the study sponsor or research team.

Azadeh Dastmalchi, PhD

CONTACT

[email protected]

+1(613)2761413

Sponsors and collaborators

Lead sponsor

VitalTracer Ltd.

Industry

Collaborators

  • St. Justine's Hospital

Registry information

Official study title

Validation of Vital Signs Recording With VT-Patch® Connected Devices in Children

Acronym: VT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2022
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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