The optimal target for systemic oxygenation in critically ill children is unknown. Liberal oxygenation is widely practiced, but has been associated with harm in paediatric patients. We aimed to evaluate whether conservative oxygenation would reduce duration of organ support or incidence of death compared to standard care. Oxy-PICU was a pragmatic, multicentre, open-label, randomised controlled trial in 15 UK paediatric intensive care units (PICUs). Children admitted as an emergency, who were older than 38 weeks corrected gestational age and younger than 16 years receiving invasive ventilation and supplemental oxygen were randomly allocated in a 1:1 ratio via a concealed, central, web-based randomisation system to conservative peripheral oxygen saturations ([SpO] 88–92%) or liberal (SpO >94%) targets. The primary outcome was the duration of organ support at 30 days following random allocation, a rank-based endpoint with death either on or before day 30 as the worst outcome (a score equating to 31 days of organ support), with survivors assigned a score between 1 and 30 depending on the number of calendar days of organ support received. The primary effect estimate was the probabilistic index, a value greater than 0·5 indicating more than 50% probability that conservative oxygenation is superior to liberal oxygenation for a randomly selected patient. All participants in whom consent was available were included in the intention-to-treat analysis. The completed study was registered with the ISRCTN registry (ISRCTN92103439). Between Sept 1, 2020, and May 15, 2022, 2040 children were randomly allocated to conservative or liberal oxygenation groups. Consent was available for 1872 (92%) of 2040 children. The conservative oxygenation group comprised 939 children (528 [57%] of 927 were female and 399 [43%] of 927 were male) and the liberal oxygenation group included 933 children (511 [56%] of 920 were female and 409 [45%] of 920 were male). Duration of organ support or death in the first 30 days was significantly lower in the conservative oxygenation group (probabilistic index 0·53, 95% CI 0·50–0·55; p=0·04 Wilcoxon rank-sum test, adjusted odds ratio 0·84 [95% CI 0·72–0·99]). Prespecified adverse events were reported in 24 (3%) of 939 patients in the conservative oxygenation group and 36 (4%) of 933 patients in the liberal oxygenation group. Among invasively ventilated children who were admitted as an emergency to a PICU receiving supplemental oxygen, a conservative oxygenation target resulted in a small, but significant, greater probability of a better outcome in terms of duration of organ support at 30 days or death when compared with a liberal oxygenation target. Widespread adoption of a conservative oxygenation saturation target (SpO 88–92%) could help improve outcomes and reduce costs for the sickest children admitted to PICUs. UK National Institute for Health and Care Research Health Technology Assessment Programme.

中文翻译：

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危重儿童的保守氧合目标与自由氧合目标 (Oxy-PICU)：一项英国多中心、开放、平行组、随机临床试验

危重儿童全身氧合的最佳目标尚不清楚。自由氧合被广泛应用，但对儿科患者造成伤害。我们的目的是评估与标准护理相比，保守氧合是否会减少器官支持的持续时间或死亡发生率。Oxy-PICU 是一项在英国 15 个儿科重症监护病房 (PICU) 中进行的实用、多中心、开放标签、随机对照试验。因急诊入院、校正胎龄大于 38 周且小于 16 岁且接受有创通气和补充供氧的儿童通过隐蔽、中央、基于网络的随机分配系统以 1:1 的比例随机分配至保守的外周供氧饱和度 ([SpO] 88–92%) 或宽松 (SpO >94%) 目标。主要结果是随机分配后第 30 天的器官支持持续时间，这是一个基于排名的终点，其中第 30 天或之前的死亡为最差结果（分数相当于 31 天的器官支持），幸存者被分配一个分数1 到 30 之间，具体取决于收到的器官支持的日历天数。主要效应估计是概率指数，该值大于 0·5，表明对于随机选择的患者，保守氧合优于自由氧合的概率超过 50%。所有获得同意的参与者均纳入意向治疗分析。已完成的研究已在 ISRCTN 注册中心注册 (ISRCTN92103439)。2020年9月1日至2022年5月15日期间，2040名儿童被随机分配到保守氧合组或自由氧合组。2040 名儿童中有 1872 名（92%）获得了同意。保守氧合组包括 939 名儿童（927 名儿童中 528 名 [57%] 为女性，927 名儿童中 399 名 [43%] 为男性），自由氧合组包括 933 名儿童（920 名儿童中 511 名 [56%] 为女性，409 名[45] 为男性）。 920 人中的 %] 为男性）。保守氧合组前 30 天内的器官支持或死亡持续时间显着较短（概率指数 0·53，95% CI 0·50–0·55；p=0·04 Wilcoxon 秩和检验，调整赔率比率 0·84 [95% CI 0·72–0·99]）。保守氧合组 939 名患者中有 24 名（3%）报告了预先设定的不良事件，自由氧合组 933 名患者中有 36 名（4%）报告了预先设定的不良事件。在紧急送入 PICU 接受补充供氧的有创通气儿童中，与传统氧合目标相比，保守氧合目标在 30 天器官支持持续时间或死亡方面产生更好结果的可能性较小，但意义重大。自由氧合目标。广泛采用保守的氧合饱和度目标（SpO 88-92%）有助于改善病情并降低入住 PICU 的病情最严重的儿童的费用。英国国家健康与护理研究所健康技术评估计划。