Departments of Emergency Medicine, Children's Critical Care, Gold Coast University Hospital, 1 Hospital Boulevard, Southport, QLD, Australia.
Child Health Research Centre, The University of Queensland, South Brisbane, Australia.
Trials. 2023 May 31;24(1):369. doi: 10.1186/s13063-023-07330-z.
The placement of an endotracheal tube for children with acute or critical illness is a low-frequency and high-risk procedure, associated with high rates of first-attempt failure and adverse events, including hypoxaemia. To reduce the frequency of these adverse events, the provision of oxygen to the patient during the apnoeic phase of intubation has been proposed as a method to prolong the time available for the operator to insert the endotracheal tube, prior to the onset of hypoxaemia. However, there are limited data from randomised controlled trials to validate the efficacy of this technique in children. The technique known as transnasal humidified rapid insufflation ventilatory exchange (THRIVE) uses high oxygen flow rates (approximately 2 L/kg/min) delivered through nasal cannulae during apnoea. It has been shown to at least double the amount of time available for safe intubation in healthy children undergoing elective surgery. The technique and its application in real time have not previously been studied in acutely ill or injured children presenting to the emergency department or admitted to an intensive care unit. The Kids THRIVE trial is a multicentre, international, randomised controlled trial (RCT) in children less than 16 years old undergoing emergent intubation in either the intensive care unit or emergency department of participating hospitals. Participants will be randomised to receive either the THRIVE intervention or standard care (no apnoeic oxygenation) during their intubation. The primary objective of the trial is to determine if the use of THRIVE reduces the frequency of oxygen desaturation and increases the frequency of first-attempt success without hypoxaemia in emergent intubation of children compared with standard practice. The secondary objectives of the study are to assess the impact of the use of THRIVE on the rate of adverse events, length of mechanical ventilation and length of stay in intensive care. In this paper, we describe the detailed statistical analysis plan as an update of the previously published protocol.
对患有急性或危重病的儿童进行气管内插管是一项低频但高风险的操作，其首次尝试失败率和不良事件发生率均较高，包括低氧血症。为了降低这些不良事件的发生频率，有人提出在插管的无通气期为患者供氧，以延长操作者在发生低氧血症之前插入气管内导管的时间。然而，关于该技术在儿童中的有效性，仅有少量来自随机对照试验的数据加以验证。经鼻高流量湿化氧疗通气交换（THRIVE）技术采用高氧流量（约 2 L/kg/min）通过鼻塞在无通气期输送，该技术已被证明可使择期手术的健康儿童安全插管的时间至少延长一倍。在紧急情况下送至急诊科或收入重症监护病房的急性病或受伤儿童中，尚未对该技术及其实时应用进行过研究。Kids THRIVE 试验是一项多中心、国际性的随机对照试验（RCT），纳入了年龄小于 16 岁的因紧急情况需要在参与医院的重症监护病房或急诊科进行插管的儿童。参与者将被随机分配到 THRIVE 干预组或标准护理组（无无通气期给氧），以接受插管期间的治疗。试验的主要目标是确定与标准治疗相比，THRIVE 的使用是否可以降低儿童紧急插管时氧饱和度下降的频率，增加首次尝试成功的频率而不发生低氧血症。该研究的次要目标是评估 THRIVE 的使用对不良事件发生率、机械通气时间和重症监护病房住院时间的影响。在本文中，我们详细描述了统计分析计划，这是对之前发表的方案的更新。
