Effectiveness of nasal high-flow oxygen during apnoea on hypoxaemia and intubation success in paediatric emergency and ICU settings: a randomised, controlled, open-label trial.

Although previous studies suggest potential benefits, it remains unclear whether NHF enhances the likelihood of achieving successful first-attempt intubation without oxygen desaturation in children.

尽管先前的研究表明有潜在的好处，但目前尚不清楚NHF是否能提高儿童首次尝试插管成功且不出现氧饱和度下降的可能性。

We aimed to investigate whether the provision of NHF oxygen during paediatric emergency intubation can improve intubation outcomes.

我们旨在调查在儿科紧急插管期间提供鼻导管高流量氧疗是否能改善插管结果。

Methods

We conducted a randomised, controlled, open-label trial at ten hospitals in Australia, New Zealand, and Switzerland (four emergency departments, ten paediatric intensive care units, and one non-maternity neonatal intensive care unit were included).

我们在澳大利亚、新西兰和瑞士的十家医院进行了一项随机、对照、开放标签试验（包括四家急诊科、十家儿科重症监护室和一家非产科新生儿重症监护室）。

Children younger than 16 years undergoing emergency endotracheal intubation were eligible for inclusion.

年龄小于16岁的儿童在进行紧急气管插管时有资格纳入研究。

Participants were randomly assigned (1:1) to receive either NHF apnoeic oxygenation or standard care during intubation.

参与者被随机分配（1:1），在插管期间接受NHF无呼吸氧疗或标准护理。

The primary outcomes were the occurrence of hypoxaemic events (defined as oxygen saturation [SpO2] ≤90%) and successful intubation on the first attempt without desaturation in the modified intention-to-treatpopulation (all intubations in participants for whom prospective or retrospective consent was given and a primary outcome was recorded).

主要结果是低氧血症事件的发生（定义为氧饱和度[SpO2] ≤90%）和在修改意向治疗人群中首次尝试成功插管且未出现氧饱和度下降（所有获得前瞻性或回顾性同意且记录了主要结果的参与者的插管）。

This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000147381) and is now completed.

该试验已在澳大利亚新西兰临床试验注册处注册（ACTRN12617000147381），目前已完成。

Results

Between May 9, 2017, and Oct 22, 2022, 1069 intubations in 969 children were randomly assigned to the NHF group (535 intubations) or standard care group (534 intubations).

在2017年5月9日至2022年10月22日期间，969名儿童的1069次插管随机分配到NHF组（535次插管）或标准护理组（534次插管）。

The primary analysis comprised 950 intubations in 860 children, with 476 intubations in the NHF group and 474 in the standard care group.

主要分析包括860名儿童的950次插管，其中NHF组有476次插管，标准护理组有474次插管。

In the NHF group, hypoxaemic events occurred in 61 (12·8%) of 476 intubations, compared with 77 (16·2%) of 474 in the standard care group (adjusted odds ratio [aOR] 0·74; 97·5% CI 0·46-1·18; p=0·15).

在NHF组中，61例（12.8%）的476次插管发生了低氧血症事件，而在标准护理组中，77例（16.2%）的474次插管发生了低氧血症事件（调整后的比值比[aOR] 0.74；97.5%置信区间[CI] 0.46-1.18；p=0.15）。

Successful intubation was achieved at the first attempt in 300 (63·0%) of 476 intubations in the NHF group and 280 (59·1%) of 474 intubations in the standard care group (aOR 1·13; 97·5% CI 0·79-1·62; p=0·43).

在NHF组中，首次尝试成功插管的有300例（63.0%）的476次插管，而在标准护理组中，首次尝试成功插管的有280例（59.1%）的474次插管（aOR 1.13；97.5% CI 0.79-1.62；p=0.43）。

In the per-protocol analysis of 905 intubations, NHF reduced the rate of hypoxaemia (48 [10·8%] of 444) compared with standard care (77 [16·7%] of 461; aOR 0·59; 97·5% CI 0·36-0·97; p=0·017).

在对905次插管进行的按方案分析中，NHF降低了低氧血症的发生率（444例中有48例[10.8%]），与标准护理相比（461例中有77例[16.7%]；aOR 0.59；97.5% CI 0.36-0.97；p=0.017）。

In this analysis, first-attempt successful intubation was achieved in 284 (64·0%) of 444 intubations in the NHF group versus 268 (58·1%) of 461 intubations in the standard care group (aOR 1·22; 97·5% CI 0·87-1·71; p=0·19).

在这项分析中，NHF组首次尝试成功插管的有284例（444例中的64.0%），而标准护理组为268例（461例中的58.1%）（aOR 1.22；97.5% CI 0.87-1.71；p=0.19）。

interpretation

The use of NHF during emergency intubation in children did not result in a reduction in hypoxaemic events or an increase in the frequency of successful intubation on the first attempt.

在儿童紧急插管过程中使用鼻咽通气道（NHF）并没有减少低氧血症事件的发生，也没有提高首次尝试插管成功的频率。

However, in the per-protocol analysis, there were fewer hypoxaemic events but no difference in successful intubation without hypoxaemia on first attempt.

然而，在按方案分析中，低氧血症事件较少，但在首次尝试插管时没有低氧血症的成功率上没有差异。

Barriers to the application of NHF during emergency intubation and the reasons for abandoning intubation attempts before physiological compromise should be further investigated to inform future research and recommendations for intubation guidelines and clinical practice.

需要进一步研究在紧急插管过程中应用鼻高流量氧疗(NHF)的障碍以及在生理受损前放弃插管尝试的原因，以告知未来的研究和插管指南以及临床实践的建议。

funding

Thrasher Research Fund (USA), National Health and Medical Research Council (Australia), and the Emergency Medicine Foundation (Australia).

Thrasher研究基金(美国)，澳大利亚国家健康与医学研究委员会，以及澳大利亚急诊医学基金会。