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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorVitalTracer Ltd.

About this trial

: 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 criteria

Qualifiers

PICU monitoring for the next 24 hours

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Non-invasive monitoring

Treatment groups

No treatment groups listed

Sponsors and collaborators

VitalTracer Ltd.

Lead sponsor

St. Justine's Hospital

Collaborator