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

This trial does not accept healthy volunteers

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 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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Non-invasive monitoring

    Device

    Comparison of VitalTracer monitoring devices with invasive and/or non-invasive gold standard reference

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
8 hours per subject

Secondary outcomes

1

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.

Time frame
8 hours per subject

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VitalTracer Ltd.

Lead sponsor

St. Justine's Hospital

Collaborator