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

Recruiting now

Conditions studied: Vital Signs, Oxygen Saturation, Children, Intensive Care Unit, Heart Rate, Respiratory Rate

In brief

: 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.

Key facts

Study ID

NCT05451875

Run by

VitalTracer Ltd.

People needed

48

Starts

2025-02-03

Expected to finish

2025-12-31

Last updated by the study team

2025-03-10

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• CHU Sainte Justin Hospital — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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