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RECRUITING
NCT05451875

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

Sponsor: VitalTracer Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

1 Day - 18 Years

Study Type

OBSERVATIONAL

Enrollment

48

Start Date

2025-02-03

Completion Date

2025-12-31

Last Updated

2025-03-10

Healthy Volunteers

No

Interventions

DEVICE

Non-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