Abstract
INTRODUCTION: More than 40,000 children undergo surgical interventions annually for the treatment of congenital heart defects. Intraoperative and postoperative vital sign monitoring is a cornerstone of pediatric care. METHODS: A single-arm prospective observational study was performed. Pediatric patients undergoing a procedure with a planned admission to the Cardiac Intensive Care Unit at Lurie Children's Hospital (Chicago, IL) were eligible for enrollment. Participant vital signs were monitored using standard equipment and an FDA-cleared experimental device (ANNE(®) ) consisting of a wireless patch positioned at the suprasternal notch and index finger or foot. The primary goal of the study was to assess real-world feasibility of wireless sensors in pediatric patients with congenital cardiac defects. RESULTS: A total of 13 patients were enrolled, ranging in age from 4 months to 16 years with a median age of 4 years. Overall, 54% (n = 7) were female and the most common anomaly in the cohort was an atrial septal defect (n = 6). The mean admission length was 3 days (range 2-6), resulting in more than 1000 h of vital sign monitoring (⟩60,000 data points). Bland-Altman plots were generated for heart rate and respiratory rate to assess beat-to-beast differences between the standard equipment and the experimental sensors. CONCLUSIONS: Novel, wireless, flexible sensors demonstrated comparable performance to standard monitoring equipment in a cohort of pediatric patients with congenital cardiac heart defects undergoing surgery.