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

NCT05451875 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2025-03-10

No results posted yet for this study

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

Interventions

DEVICE

Non-invasive monitoring

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

Sponsors & Collaborators

  • St. Justine's Hospital

    collaborator OTHER

  • VitalTracer Ltd.

    lead INDUSTRY

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2025-09-01
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05451875 on ClinicalTrials.gov