Validation of Vital Signs Recording With VT-Patch4 Connected Devices in Children

What this Trial Is About

Researchers are evaluating the accuracy of the VT-Patch4 connected device for measuring vital signs in children with diverse skin colors. The study focuses on children in Pediatric Intensive Care Units (PICU), as patient readmission is linked to higher risks of complications and death. Current connected devices for adults may not work well for children, especially for those with dark skin tones, which can affect optical sensor accuracy. The study will take place in two phases: a run-in phase testing the VT-Patch4 on four children to check protocol feasibility, followed by the main validation phase involving 12 children per age group. The VT-Patch4 will record five vital signs, including oxygen saturation, heart rate, respiratory rate, temperature, and electrocardiogram (ECG), for 8 hours while compared to the standard monitoring system. The device will also explore blood pressure and movement capture. Participants will be monitored continuously for 8 hours with the VT-Patch4 and standard devices, but the connected device data will not influence clinical care. Skin color will be assessed using the Monk scale to evaluate device accuracy across different tones. The primary outcome measures oxygen saturation accuracy, while secondary outcomes include blood pressure, heart rate, temperature, and ECG measurements. The study starts in February 2025 and ends in December 2025.

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