Multicentre paired non-inferiority study of the cardiorespiratory monitoring performance of the wireless and non-adhesive Bambi® belt measuring diaphragm activity in neonates: study protocol.

Autor:	Scholten AWJ; Amsterdam UMC location University of Amsterdam, Department of Neonatology, Meibergdreef 9, Amsterdam, The Netherlands a.w.j.scholten@amsterdamumc.nl.; Amsterdam Reproduction & Development research institute, Amsterdam, The Netherlands., Zhan Z; Eindhoven University of Technology, Department of Mathematics and Computer Science, Eindhoven, The Netherlands., Niemarkt HJ; Máxima Medical Center, Department of Neonatology, Veldhoven, The Netherlands., Vervoorn M; Máxima Medical Center, Department of Neonatology, Veldhoven, The Netherlands., van Leuteren RW; Amsterdam UMC location University of Amsterdam, Department of Neonatology, Meibergdreef 9, Amsterdam, The Netherlands.; Amsterdam Reproduction & Development research institute, Amsterdam, The Netherlands., de Jongh FH; Amsterdam UMC location University of Amsterdam, Department of Neonatology, Meibergdreef 9, Amsterdam, The Netherlands.; University of Twente, Faculty of Science and Technology, Enschede, The Netherlands., van Kaam AH; Amsterdam UMC location University of Amsterdam, Department of Neonatology, Meibergdreef 9, Amsterdam, The Netherlands.; Amsterdam Reproduction & Development research institute, Amsterdam, The Netherlands., van den Heuvel ER; Eindhoven University of Technology, Department of Mathematics and Computer Science, Eindhoven, The Netherlands., Hutten GJ; Amsterdam UMC location University of Amsterdam, Department of Neonatology, Meibergdreef 9, Amsterdam, The Netherlands.; Amsterdam Reproduction & Development research institute, Amsterdam, The Netherlands.
Jazyk:	angličtina
Zdroj:	BMJ paediatrics open [BMJ Paediatr Open] 2022 Jun; Vol. 6 (1).
DOI:	10.1136/bmjpo-2022-001430
Abstrakt:	Introduction: Cardiorespiratory monitoring is used in the neonatal intensive care unit (NICU) to assess the clinical status of newborn infants and detect critical deteriorations in cardiorespiratory function. Currently, heart rate (HR) is monitored by electrocardiography (ECG) and respiration by chest impedance (CI). Disadvantages of current monitoring techniques are usage of wired adhesive electrodes which may damage the skin and hinder care. The Bambi® belt is a wireless and non-adhesive alternative that enables cardiorespiratory monitoring by measuring electrical activity of the diaphragm via transcutaneous electromyography. A previous study showed feasibility of the Bambi® belt and this study compares the belt performance to ECG and CI. Methods and Analysis: This multicentre non-inferiority paired study will be performed in the NICU of the Máxima Medical Center (MMC) in Veldhoven and the Emma Children's Hospital, Amsterdam University Medical Centre (AmsterdamUMC) in Amsterdam, The Netherlands. 39 infants in different postmenstrual age groups (minimally 10 infants<30 weeks, between 30-32 weeks and >32 weeks) will be recruited. These infants will be monitored with the Bambi® belt in addition to standard ECG and CI for 24 hours. The primary outcome is the HR, studied with three criteria: (1) the limits of agreement of the HR measurements in terms of the second-to-second difference in the HR between the belt and standard ECG, (2) the detection of cardiac events consisting of bradycardia and tachycardia and (3) the quality of HR-monitoring. The secondary outcome is the respiratory rate (RR), studied with the criteria (1) agreement in RR-trend monitoring, (2) apnoea and tachypnoea detection and (3) reliable registrations. Ethics and Dissemination: This protocol was approved by the Medical Ethical Committee of the MMC and the Central Committee for Human Research. The MMC started patient recruitment in July and the AmsterdamUMC in August 2021. The results will be presented at conferences and published in peer-reviewed journals. Trial Registration Number: NL9480. Competing Interests: Competing interests: Bambi Medical B.V. supports the study by a financial grant and use of equipment free of charge. Data collection, analysis, interpretation and reporting will be done independent of Bambi Medical B.V. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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