Oxygen saturation thresholds in children with acute respiratory distress (OxyKids): a multicentre, open, parallel-group, randomised clinical trial.

We assessed whether an SpO2 threshold of 88% versus 92% could safely reduce length of hospital stay.

我们评估了将外周氧饱和度（SpO2）阈值设定为88%与92%相比，是否能安全地减少住院时间。

Methods

We did a multicentre, open-label, randomised controlled trialin ten general and teaching hospitals in the Netherlands.

我们在荷兰的十家普通和教学医院进行了一项多中心、开放标签、随机对照试验。

Children (aged 6 weeks-12 years) requiring oxygen therapy for bronchiolitis, lower respiratory tract infection, or acute viral-induced wheeze were randomly assigned (1:1), stratified by centre and age group, to an 88% (intervention) or 92% (control) SpO2 threshold.

需要氧疗的儿童（6周至12岁）因细支气管炎、下呼吸道感染或急性病毒性喘息，按照1:1的比例，按中心和年龄组分层，随机分配到88%（干预组）或92%（对照组）的SpO2阈值。

SpO2 measurement and delivery of oxygen (via low-flow or high-flow nasal cannula or face mask) used standard equipment and protocols available on the participating general paediatric wards.

SpO2测量和氧气输送（通过低流量或高流量鼻导管或面罩）使用了参与的普通儿科病房上可用的标准设备和协议。

All other treatments (such as bronchodilators, corticosteroids, feeding) followed local protocols.

所有其他治疗（如支气管扩张剂、皮质类固醇、喂养）遵循当地协议。

Masking for the study was precluded due to device regulation requirements.

由于设备监管要求，该研究无法进行盲法设计。

The primary outcome was time from admission to meeting predefined discharge criteria, analysed in the intention-to-treatpopulation.

主要结果指标是从入院到达到预设出院标准的时间，在意向治疗人群中进行分析。

Harms and adverse events were analysed in the intention-to-treatpopulation.

在意向治疗人群中分析了伤害和不良事件。

Missing primary outcome data were imputed using the latest of either discharge time minus the mean discharge-criteria-to-discharge interval or the last known criterion time.

缺失的主要结果数据使用最新的出院时间减去平均出院标准到出院间隔或最后已知的标准时间进行估算。

Missing covariates were handled via multiple imputation (20 datasets, Rubin's Rules).

缺失的协变量通过多重插补（20个数据集，Rubin规则）处理。

This trial was registered in the EU Clinical Trials Register (EUCTR 2023-504817-56) and ClinicalTrials.gov (NCT06016244) and is completed.

该试验已在欧盟临床试验注册处（EUCTR 2023-504817-56）和ClinicalTrials.gov（NCT06016244）注册，并已完成。

Results

Between Sep 5, 2023, and Dec 4, 2024, 2114 patients were assessed for eligibility, 512 were excluded (425 did not meet inclusion criteria and 87 did not require oxygen therapy) and 1602 met the inclusion criteria.

在2023年9月5日至2024年12月4日期间，共有2114名患者被评估是否符合纳入标准，其中512名患者被排除在外（425名患者不符合纳入标准，87名患者不需要氧疗），最终有1602名患者符合纳入标准。

A further 1036 patients were excluded and 566 were randomly assigned (282 to the 88% SpO2 group and 284 to the 92% SpO2 group). 278 participants were included in the intention-to-treatanalysis for the 88% group and 279 were included in the analysis for the 92% group. 317 (57%) of the 557 participants were male and 240 (43%) were female.

进一步排除了1036名患者后，有566名患者被随机分配（282名患者分配至88% SpO2组，284名患者分配至92% SpO2组）。88%组有278名参与者被纳入意向治疗分析，92%组有279名参与者被纳入分析。在557名参与者中，有317名（57%）为男性，240名（43%）为女性。

The mean overall age of the cohort was 2·0 (SD 2·4) years, and 437 (91%) of 480 participants who provided ethnicity data were Dutch.

队列的平均年龄为2.0（标准差2.4）岁，480名提供种族数据的参与者中有437名（91%）是荷兰人。

Median time to meeting discharge criteria was 27·6 h [IQR 15·1-52·7] in the 88% group versus 46·6 h [24·2-85·1] in the 92% group (adjusted geometric mean ratio (GMR) of 0·64 (95% CI 0·55-0·74; p<0·0001); adjusted absolute difference of 16·8 h (95% CI 12·1-20·8; p<0·0001).

在达到出院标准的中位时间上，88%组为27.6小时（四分位数间距15.1-52.7），而92%组为46.6小时（四分位数间距24.2-85.1）（调整后的几何平均比率为0.64（95%置信区间0.55-0.74；p<0.0001）；调整后的绝对差异为16.8小时（95%置信区间12.1-20.8；p<0.0001）。

Median hospital stay was 39·8 h [IQR 22·0-67·2] versus 60·8 h [38·5-95·8] (adjusted difference 17·6 h [95% CI 12·5-22·6]; p<0·0001).

中位住院时间分别为39.8小时 [四分位数间距 22.0-67.2] 和60.8小时 [38.5-95.8]（调整后差异17.6小时 [95% 置信区间 12.5-22.6]; p<0.0001）。

Oxygen therapy was started less often and duration was significantly shorter (adjusted GMR 0·64 [95% CI 0·52-0·77] p<0·0001); in the 88% group.

氧疗的启动频率更低，且持续时间显著缩短（调整后几何均数比0.64 [95% 置信区间 0.52-0.77] p<0.0001）；在88%的组别中。

Serious adverse events, post-discharge health-care visits within 28 days, recovery time, and parental anxiety did not statistically differ between groups.

我们的研究发现，在一般儿科护理中，6周至12岁患有急性呼吸道疾病的儿童，将SpO2阈值设定为88%可以减少治疗负担，通过缩短住院时间和氧疗，覆盖广泛的呼吸疾病诊断，且没有短期内伤害的证据。

interpretation

Our findings suggest that an 88% SpO2 threshold in children aged 6 weeks-12 years with acute respiratory illness in general paediatric care reduces treatment burden by reducing hospital stay duration and oxygen therapy across a broad range of respiratory diagnoses, without evidence of short-term harm.

我们的研究结果表明，在6周至12岁患有急性呼吸系统疾病的儿童中，将SpO2阈值设定为88%可以减少治疗负担，通过缩短住院时间和减少氧疗来实现，这适用于广泛的呼吸系统诊断，且没有短期伤害的证据。

funding

ZonMw, The Dutch Foundation for Asthma Prevention, the Spaarne Gasthuis and Amphia Hospital Research Funds, and the Dutch General Paediatrics Research Network of the Dutch Association for Paediatrics.

荷兰哮喘预防基金会ZonMw、斯帕恩医院和安菲亚医院研究基金以及荷兰儿科协会荷兰普通儿科研究网络。