RecruitingNCT05451875

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

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


Sponsor

VitalTracer Ltd.

Enrollment

48 participants

Start Date

Feb 3, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 1 DayMax Age: 18 Years

Inclusion Criteria1

  • PICU monitoring for the next 24 hours

Exclusion Criteria4

  • 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

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Interventions

DEVICENon-invasive monitoring

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


Locations(1)

CHU Sainte Justin Hospital

Montreal, Quebec, Canada

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NCT05451875


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