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

Abstract

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 < 0.001). Second, sensitivity and positive predictive value (PPV) for cardiac event detection were 94.0% (SE = 0.5%) and 92.6% (SE = 0.6%), respectively (p ≤ 0.001). Third, the incidence of HR‐data loss was 2.1% (SE = 0.4%) per second (p < 0.05). The exploratory analyses of RR showed moderate trend agreement with a mean RR‐difference of 3.7 breaths/min (SE = 0.8) (LoA: [−12 to 19] breaths/min), but low sensitivities and PPV's for apnea/tachypnea detection. The incidence of RR‐data loss was 2.2% (SE = 0.4%) per second.ConclusionThe nonadhesive, wireless belt showed non‐inferior HR monitoring and a moderate agreement in RR trend compared to ECG/CI. Future research on apnea/tachypnea detection is required.

The Effects of a New Wireless Non-Adhesive Cardiorespiratory Monitoring Device on the Skin Conditions of Preterm Infants

“…In our opinion, a swift replacement of the belt to correct the position would have prevented these adverse events. Indeed, in our 24 h feasibility and monitoring study, no adverse skin events were reported [ 15 , 16 ].…”

“…This study was approved by the Ethical Board of the Máxima Medical Centre (NL77561.015.21) and registered in the Netherlands Trial Register (NL 9478). This study was performed in addition to a multicenter monitor performance study of the Bambi Belt (NL9480) [ 16 ]. This study was monitored by an independent body (Clinical Trial Centre Maastricht).…”

“…The feasibility and safety of this device were tested in a pilot study recently, with the measurements lasting up to three days [ 15 ]. Furthermore, the belt was non-inferior in heart rate monitoring compared to standard ECG with adhesive electrodes [ 16 ]. Nevertheless, the effects of prolonged Bambi Belt wearing on skin conditions have not been investigated.…”