Cardiorespiratory monitoring with a wireless and nonadhesive belt measuring diaphragm activity in preterm and term infants: A multicenter non‐inferiority study

IntroductionWe determined if the heart rate (HR) monitoring performance of a wireless and nonadhesive belt is non‐inferior compared to standard electrocardiography (ECG). Secondary objective was to explore the belt's respiratory rate (RR) monitoring performance compared to chest impedance (CI).MethodIn this multicenter non‐inferiority trial, preterm and term infants were simultaneously monitored with the belt and conventional ECG/CI for 24 h. HR monitoring performance was estimated with the HR difference and ability to detect cardiac events compared to the ECG, and the incidence of HR‐data loss per second. These estimations were statistically compared to prespecified margins to confirm equivalence/non‐inferiority. Exploratory RR analyses estimated the RR trend difference and ability to detect apnea/tachypnea compared to CI, and the incidence of RR‐data loss per second.ResultsThirty‐nine infants were included. HR monitoring with the belt was non‐inferior to the ECG with a mean HR difference of 0.03 beats per minute (bpm) (standard error [SE] = 0.02) (95% limits of agreement [LoA]: [−5 to 5] bpm) (p