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

NCT05451875 | Recruiting DMC

• 1 other identifier: VT001
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

: 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.

Conditions

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

Keywords

Vital signs; SPO2; ECG; Continuous; Skin temperature; Heart rate; VitalTracer; Wearable; All-in-one; Children; PICU; Different Skin Color; Dark skin color; Monk Scale

Outcome Measures

Primary Outcomes (1)

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

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

  8 hours per subject

Secondary Outcomes (1)

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

  8 hours per subject

Interventions

Non-invasive monitoring DEVICE

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

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

In order to achieve at least 80% match between physiological data's recorded with VT-Patch®, or VT-Watch® and with the standard of care (tolerated difference: 2% for SpO2), this study will include 10 patients per age group (see below) including 4 patients per age group with invasive arterial pressure monitoring (arterial line). 1. Neonates: 0 - 28 days 2. Infants:29 days - 2 years 3. Children: 2 - 12 years 4. Adolescents:12 - 18 years

You may qualify if:

• PICU monitoring for the next 24 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• VitalTracer Ltd.: lead
• St. Justine's Hospital: collaborator

Study Sites (1)

CHU Sainte Justin Hospital

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Central Study Contacts

Azadeh Dastmalchi, PhD

CONTACT

+1(613)2761413; azadeh.dastmalchi@vitaltracer.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 11, 2022
• Study Start: February 3, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

CA (1)