随机对照试验：高流量氧疗在毛细支气管炎患儿中的应用
A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis.
机构信息
From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).
出版信息
N Engl J Med. 2018 Mar 22;378(12):1121-1131. doi: 10.1056/NEJMoa1714855.
BACKGROUND
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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 .).
背景
尽管高流量鼻导管吸氧治疗在毛细支气管炎婴儿中的疗效的高质量证据有限，但通过鼻导管进行高流量氧疗的应用越来越广泛。在重症监护病房（ICU）以外的环境中，通过鼻导管进行高流量氧疗的疗效尚不清楚。
方法
在这项多中心、随机、对照试验中，我们将患有毛细支气管炎且需要补充氧疗的 12 个月以下婴儿随机分为接受高流量氧疗（高流量组）或标准氧疗（标准治疗组）的两组。标准治疗组的婴儿如果符合治疗失败的标准，可以接受高流量氧疗的抢救。主要结局是治疗失败导致的治疗升级（定义为满足以下 4 项临床标准中的≥3 项：持续心动过速、呼吸急促、低氧血症和医院预警工具触发的医疗审查）。次要结局包括住院时间、氧疗时间以及转至三级医院、入住 ICU、插管和不良事件的发生率。
结果
共纳入 1472 例患者。高流量组中有 12%（87/739 例）的婴儿需要治疗升级，而标准治疗组中有 23%（167/733 例）需要治疗升级（风险差异，-11 个百分点；95%置信区间，-15 至-7；P<0.001）。两组的住院时间和氧疗时间无显著差异。在每组中，各有 1 例气胸（<1%的婴儿）发生。在标准治疗组中 167 例治疗失败的婴儿中，有 102 例（61%）对高流量抢救治疗有反应。
结论
在 ICU 外接受治疗的毛细支气管炎婴儿中，与接受标准氧疗的婴儿相比，接受高流量氧疗的婴儿治疗失败导致治疗升级的比例显著降低。（由澳大利亚国家卫生和医学研究委员会等资助；澳大利亚和新西兰临床试验注册中心编号：ACTRN12613000388718 。）
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