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

Abstract

IntroductionCardiorespiratory 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 analysisThis 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 disseminationThis 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 numberNL9480.

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

“…The three ECG/CI electrodes were placed on the standard location (see Figure 1). The study procedures are described in detail in the published study protocol 9 . In brief, the sensor module (attached to the belt) transmits the measured dEMG to the receiver module which processes the data and provides the ECG and respiration waveform from which the HR and RR were calculated.…”

“…The study procedures are described in detail in the published study protocol. 9 In brief, the sensor module (attached to the belt) transmits the measured dEMG to the receiver module which processes the data and provides the ECG and respiration waveform from which the HR and RR were calculated. These data and the data from the patient monitor (ECG, HR, RR, and peripheral oxygen saturation [SpO 2 ]) were transported to the bedside computer.…”

“…The power calculation was described in our published study protocol. 9 In short, this was based on previously collected data 8 and yielded 39 infants to achieve 80% power with an overall 5% type I error with a Bonferroni correction for multiplicity (see Supporting Information: 1). An interim analysis was performed at 13 included infants, which revealed that the sample size was adequate.…”