TY - JOUR
T1 - Cardiorespiratory monitoring with a wireless and nonadhesive belt measuring diaphragm activity in preterm and term infants
T2 - A multicenter non-inferiority study
AU - Scholten, Anouk W. J.
AU - Zhan, Zhuozhao
AU - Niemarkt, Hendrik J.
AU - Vervoorn, Marieke
AU - van Leuteren, Ruud W.
AU - de Jongh, Frans H.
AU - van Kaam, Anton H.
AU - Heuvel, Edwin R. van den
AU - Hutten, Gerard J.
N1 - Funding Information: 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. Funding Information: 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. Publisher Copyright: © 2023 The Authors. Pediatric Pulmonology published by Wiley Periodicals LLC.
PY - 2023/12
Y1 - 2023/12
N2 - 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.
AB - 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.
KW - newborn infants
KW - preterm infants
KW - transcutaneous electromyography
UR - http://www.scopus.com/inward/record.url?scp=85173517544&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/ppul.26695
DO - https://doi.org/10.1002/ppul.26695
M3 - Article
C2 - 37795597
SN - 8755-6863
VL - 58
SP - 3574
EP - 3581
JO - Pediatric pulmonology
JF - Pediatric pulmonology
IS - 12
ER -