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

Anouk W.J. Scholten (Corresponding author), Zhuozhao Zhan, Hendrik J. Niemarkt, Marieke Vervoorn, Ruud W. van Leuteren, Frans H. de Jongh, Anton H. van Kaam, Edwin R. van den Heuvel, Gerard J. Hutten (Corresponding author)

Onderzoeksoutput: Bijdrage aan tijdschriftTijdschriftartikelAcademicpeer review

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Samenvatting

Introduction: We 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). Method: In 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. Results: Thirty-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. Conclusion: The 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.

Originele taal-2Engels
Pagina's (van-tot)3574-3581
Aantal pagina's8
TijdschriftPediatric Pulmonology
Volume58
Nummer van het tijdschrift12
Vroegere onlinedatum5 okt. 2023
DOI's
StatusGepubliceerd - dec. 2023

Financiering

The authors thank the research nurses of the MMC for contributing to fulfilling measurements. This work was supported by the Louise Vehmeijer Foundation. Bambi Medical B. V. supported the study by a financial grant and use of equipment free of charge. Data collection, analysis, interpretation, and reporting was done independent of Bambi Medical B. V.

FinanciersFinanciernummer
Louise Vehmeijer Foundation
Mackay Medical College

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