Validation of Vital Signs Recording with VT-Patch Connected Devices in Children
About the study
: 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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
* PICU monitoring for the next 24 hours
EXCLUSION CRITERIA
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 Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Vital Signs,Oxygen Saturation,Children,Intensive Care Unit,Heart Rate,Respiratory Rate
Age
1 - 18
Participants Needed
48
Est. Completion Date
Dec 31, 2025
Treatment Type
OBSERVATIONAL
Sponsor
VitalTracer Ltd.
ClinicalTrials.gov NCT Identifier
NCT05451875
Study Number
VT-001
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