新生儿气管插管期间经鼻高流量通气稳定化的多中心随机试验（SHINE试验）：研究方案
A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): a study protocol.
作者信息
Hodgson Kate A, Owen Louise S, Kamlin Camille Omar, Roberts Calum T, Donath Susan M, Davis Peter G, Manley Brett James
机构信息
Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia
Department of Obstetrics and Gynaecology, The University of Melbourne, Melbourne, Victoria, Australia.
出版信息
BMJ Open. 2020 Oct 5;10(10):e039230. doi: 10.1136/bmjopen-2020-039230.
INTRODUCTION
Neonatal endotracheal intubation is an essential but potentially destabilising procedure. With an increased focus on avoiding mechanical ventilation, particularly in preterm infants, there are fewer opportunities for clinicians to gain proficiency in this important emergency skill. Rates of successful intubation at the first attempt are relatively low, and adverse event rates are high, when compared with intubations in paediatric and adult populations. Interventions to improve operator success and patient stability during neonatal endotracheal intubations are needed. Using nasal high flow therapy extends the safe apnoea time of adults undergoing upper airway surgery and during endotracheal intubation. This technique is untested in neonates.
METHODS AND ANALYSIS
The tabilisation with nasal igh flow during ntubation of onates (SHINE) trial is a multicentre, randomised controlled trial comparing the use of nasal high flow during neonatal intubation with standard care (no nasal high flow). Intubations are randomised individually, and stratified by site, use of premedications, and postmenstrual age (<28 weeks' gestation; ≥28 weeks' gestation). The primary outcome is the incidence of successful intubation on the first attempt without physiological instability of the infant. Physiological instability is defined as an absolute decrease in peripheral oxygen saturation >20% from preintubation baseline and/or bradycardia (<100 beats per minute).
ETHICS AND DISSEMINATION
The SHINE trial received ethical approval from the Human Research Ethics Committees of The Royal Women's Hospital, Melbourne, Australia and Monash Health, Melbourne, Australia. The trial is currently recruiting in these two sites. The findings of this study will be disseminated via peer-reviewed journals and presented at national and international conferences.
TRIAL REGISTRATION NUMBER
ACTRN12618001498280.
引言
新生儿气管插管是一项必不可少但可能导致不稳定的操作。随着越来越注重避免机械通气，尤其是在早产儿中，临床医生获得这项重要急救技能熟练程度的机会减少。与儿科和成人气管插管相比，首次尝试成功插管的比率相对较低，不良事件发生率较高。需要采取干预措施来提高新生儿气管插管期间操作人员的成功率和患者的稳定性。使用经鼻高流量治疗可延长接受上呼吸道手术和气管插管的成年人的安全窒息时间。该技术在新生儿中未经测试。
方法与分析
新生儿插管时经鼻高流量稳定化（SHINE）试验是一项多中心随机对照试验，比较新生儿插管期间使用经鼻高流量与标准护理（不使用经鼻高流量）的情况。插管进行个体随机分组，并按地点、术前用药情况和孕龄（<28周妊娠；≥28周妊娠）分层。主要结局是首次尝试成功插管且婴儿无生理不稳定的发生率。生理不稳定定义为外周血氧饱和度较插管前基线绝对下降>20%和/或心动过缓（<每分钟100次心跳）。
伦理与传播
SHINE试验获得了澳大利亚墨尔本皇家妇女医院和澳大利亚墨尔本莫纳什健康中心人类研究伦理委员会的伦理批准。该试验目前正在这两个地点招募受试者。本研究结果将通过同行评审期刊进行传播，并在国内和国际会议上发表。
试验注册号
ACTRN12618001498280。
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