Amsterdam UMC location University of Amsterdam, Department of Neonatology, Meibergdreef 9, Amsterdam, The Netherlands
Amsterdam Reproduction & Development research institute, Amsterdam, The Netherlands.
BMJ Paediatr Open. 2022 Jun;6(1). doi: 10.1136/bmjpo-2022-001430.
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.
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.
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.
NL9480.
心肺监测在新生儿重症监护病房（NICU）中用于评估新生儿的临床状况，并检测心肺功能的危急恶化。目前，心率（HR）通过心电图（ECG）监测，呼吸通过胸部阻抗（CI）监测。目前监测技术的缺点是使用有线粘性电极，这可能会损坏皮肤并妨碍护理。Bambi®腰带是一种无线且非粘性的替代品，通过经皮肌电图测量膈肌的电活动来实现心肺监测。先前的研究表明了 Bambi®腰带的可行性，本研究将比较该腰带与 ECG 和 CI 的性能。
这项多中心非劣效性配对研究将在荷兰 Veldhoven 的 Máxima 医疗中心（MMC）和荷兰阿姆斯特丹大学医学中心（阿姆斯特丹 UMC）的 Emma 儿童医院的 NICU 进行。将招募 39 名不同胎龄组的婴儿（至少 10 名婴儿<30 周，30-32 周之间和>32 周）。这些婴儿将在标准 ECG 和 CI 监测的基础上，使用 Bambi®腰带监测 24 小时。主要结局是心率（HR），研究采用三个标准：（1）HR 测量值的一致性，即 HR 第二秒与标准 ECG 之间的第二秒差异；（2）检测心动过缓和心动过速等心脏事件；（3）HR 监测的质量。次要结局是呼吸频率（RR），研究采用以下标准：（1）RR 趋势监测的一致性；（2）呼吸暂停和呼吸急促的检测；（3）可靠的记录。
本方案已获得 MMC 医学伦理委员会和中央人类研究委员会的批准。MMC 于 2021 年 7 月开始招募患者，阿姆斯特丹 UMC 于 8 月开始招募患者。研究结果将在会议上展示，并发表在同行评议的期刊上。
NL9480。
