Recruiting

VT-Patch

Sponsor:

VitalTracer Ltd.

Code:

NCT05451875

Conditions

Vital Signs

Oxygen Saturation

Children

Intensive Care Unit

Heart Rate

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Non-invasive monitoring

Study Details

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

Study ID

NCT05451875

Start date

Feb 3, 2025

Status verified date

Mar, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Interventions and Outcome Measures

Interventions

Non-invasive monitoring

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

Primary outcome measure

  • Accuracy of VitalTracer devices Oxygen Saturation (SPO2) measurement for different skin colour [ Time Frame: 8 hours per subject ]

Central Contacts and Locations

Central contacts

Locations

CHU Sainte Justin Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Principal Investigator:

Philippe Jouvet, MD, PhD

More Information

Sponsor

VitalTracer Ltd.

Last update posted

Mar 10, 2025

Last verified

Mar, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VitalTracer Ltd. on 2025-03-10.