ORIGINAL ARTICLE
A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis
Donna Franklin, Franz E. Babl, Luregn J. Schlapbach, et al
N Engl J Med 2018; 378:1121-1131
DOI: 10.1056/NEJMoa1714855
Abstract
BACKGROUND 背景
High-flow oxygen therapy through a nasal cannula has been increasingly used in infants with bronchiolitis, despite limited high-quality evidence of its efficacy. The efficacy of high-flow oxygen therapy through a nasal cannula in settings other than intensive care units (ICUs) is unclear.
尽管仅有有限的高质量证据证实其疗效，但经鼻导管高流量氧疗越来越多的用于治疗婴儿的支气管炎。在ICU以外经鼻导管进行高流量氧疗的疗效尚不清楚。
METHODS 方法
In this multicenter, randomized, controlled trial, we assigned infants younger than 12 months of age who had bronchiolitis and a need for supplemental oxygen therapy to receive either high-flow oxygen therapy (high-flow group) or standard oxygen therapy (standard-therapy group). Infants in the standard-therapy group could receive rescue high-flow oxygen therapy if their condition met criteria for treatment failure. The primary outcome was escalation of care due to treatment failure (defined as meeting ≥3 of 4 clinical criteria: persistent tachycardia, tachypnea, hypoxemia, and medical review triggered by a hospital early-warning tool). Secondary outcomes included duration of hospital stay, duration of oxygen therapy, and rates of transfer to a tertiary hospital, ICU admission, intubation, and adverse events.
在这项多中心、随机、对照临床试验中，我们将年龄不足12个月、罹患支气管炎且需要进行氧疗的婴儿随机分组，分别接受高流量氧疗（高流量组）或标准氧疗（标准治疗组）。标准治疗组的婴儿如果满足治疗失败的标准，可以接受挽救性高流量氧疗。主要预后指标为因治疗失败而提高治疗强度（定义为以下4项临床标准中满足≥3项：持续心动过速，呼吸频数，低氧血症及医院早期预警系统预警所导致的医疗关注）。次要预后指标包括住院日，氧疗持续时间，转诊至三级医院的比例，ICU收治比例，气管插管及不良事件。
RESULTS 结果
The analyses included 1472 patients. The percentage of infants receiving escalation of care was 12% (87 of 739 infants) in the high-flow group, as compared with 23% (167 of 733) in the standard-therapy group (risk difference, −11 percentage points; 95% confidence interval, −15 to −7; P<0.001). No significant differences were observed in the duration of hospital stay or the duration of oxygen therapy. In each group, one case of pneumothorax (<1% of infants) occurred. Among the 167 infants in the standard-therapy group who had treatment failure, 102 (61%) had a response to high-flow rescue therapy.
分析共纳入1472名患儿。高流量组提高治疗强度的比例为12% (87/739)，标准治疗组为23% (167/733)（风险差异，-11百分点；95%可信限-15 to -7；p < 0.001）。住院日或氧疗持续时间并无差异。每组各有1例发生气胸（< 1%)。标准治疗组的167名治疗失败的婴儿中，102名(61%)对挽救性高流量氧疗有反应。
CONCLUSIONS 结论
Among infants with bronchiolitis who were treated outside an ICU, those who received high-flow oxygen therapy had significantly lower rates of escalation of care due to treatment failure than those in the group that received standard oxygen therapy. (Funded by the National Health and Medical Research Council and others; Australian and New Zealand Clinical Trials Registry number, ACTRN12613000388718.)
对于在ICU以外接受治疗的支气管炎婴儿，与接受标准氧疗相比，接受高流量氧疗的患儿提高治疗强度的比例较低。
