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
This trial does not accept healthy volunteersQualifiers
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 population
In order to achieve at least 80% match between physiological data's recorded with VT-Patch®, or VT-Watch® and with the standard of care (tolerated difference: 2% for SpO2), this study will include 10 patients per age group (see below) including 4 patients per age group with invasive arterial pressure monitoring (arterial line). 1. Neonates: 0 - 28 days 2. Infants:29 days - 2 years 3. Children: 2 - 12 years 4. Adolescents:12 - 18 years
Trial design
Case-only
Prospective
Treatments tested in this trial
Non-invasive monitoring
DeviceComparison of VitalTracer monitoring devices with invasive and/or non-invasive gold standard reference
Treatment groups
Trial outcomes
Primary outcomes
Accuracy of VitalTracer devices Oxygen Saturation (SPO2) measurement for different skin colour
Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded in high resolution database.
Secondary outcomes
Accuracy of VitalTracer devices blood pressure, heart rate, skin temperature, and Electrocardiogram (ECG) measurement
Percentage of the difference between the absolute value of Blood Pressure, Heart Rate and skin temperature and the quality of ECG signals recorded by the VT-Patch and the one recorded in high resolution database.
Sponsors and contacts
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VitalTracer Ltd.
Lead sponsor
St. Justine's Hospital
Collaborator