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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

: 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

Primary outcome measure(s)

• Accuracy of VitalTracer devices Oxygen Saturation (SPO2) measurement for different skin colour — 8 hours per subject
  Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded in high resolution database.

Trial sites (1)

Other trials for the same condition