Validation of Continuous Monitoring of Vital Signs in Children With VTPatch Connected Device in the Pediatric Intensive Care Unit

What this Trial Is About

Researchers are evaluating the accuracy of a connected thoracic patch called VT-Patch for continuously monitoring vital signs in children admitted to the Pediatric Intensive Care Unit (PICU). This study focuses on assessing the device's ability to measure oxygen saturation (SpO2) and other vital signs, considering the impact of different skin colors on measurement accuracy. The trial aims to address the lack of small connected devices for pediatric vital sign monitoring after PICU discharge and the challenges posed by skin pigmentation on optical sensing. Participants will be monitored using the VT-Patch device for 8 consecutive hours while also being monitored by the standard Philips monitoring system used in the PICU. The study includes two phases: a run-in phase testing feasibility on 5 children, followed by a main validation phase involving children across various age groups and skin phototypes. The device will record heart rate, SpO2, respiratory rate, temperature, blood pressure, ECG, and movement capture during the monitoring period. During the study, children's vital signs will be continuously recorded with both the VT-Patch and the standard care system for comparison. Skin color classification will be done using the Fitzpatrick scale and a non-invasive spectroscopic method. Researchers will analyze the accuracy of the VT-Patch for four main vital signs plus exploratory parameters. The study is conducted at a single center and includes safety and feasibility assessments. Participation duration for monitoring is 8 hours, with detailed data collection to validate the device's suitability for children of all skin colors.

Validation of Continuous Monitoring of Vital Signs in Children With a Connected Patch