Testing a New Abdominal Pulse Oximeter for Infants Under 1 Year Comparing Accuracy with Traditional Fingertip Devices Evaluating Oxygen Monitoring in Pediatric Intensive Care

What this Trial Is About

Researchers are evaluating a new abdominal pulse oximeter designed to be more accurate than traditional fingertip devices for monitoring oxygen levels in infants under 1 year old. This study focuses on pediatric patients admitted to intensive care units with congenital heart diseases. The goal is to test if this new device, which reduces motion-related errors by being placed on the abdomen, can provide reliable oxygen saturation readings compared to standard fingertip pulse oximeters and arterial blood measurements. The study uses an abdominal pulse oximeter prototype housed in a flexible, biocompatible clip that attaches to a babys diaper or pants to maintain contact with the skin. This device aims to minimize interference from movement and ambient light. The study collects data from routine clinical monitoring over a 3-day hospital stay without requiring additional visits. The prototypes performance will be compared against traditional fingertip pulse oximeters and the gold-standard arterial oxygen saturation measurements. Participants data are collected from their medical records during their hospital stay in intensive care. No extra study visits are needed. Researchers will evaluate the accuracy of abdominal oxygen saturation readings against arterial blood oxygen levels over 72 hours. The study will monitor for any issues related to the devices use and aims to generate evidence supporting this new technologys potential to improve infant oxygen monitoring. Participation lasts for 3 days during the hospital stay.

PRecision Integrated Saturation Monitor