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Original Investigation | October 05, 2016 CARING FOR THE CRITICALLY ILL PATIENT Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial Gonzalo Hernández, Concepción Vaquero, Laura Colinas, et al. JAMA. Published online October 05, 2016. doi:10.1001/jama.2016.14194 Importance 背景 High-flow conditioned oxygen therapy delivered through nasal cannulae and noninvasive mechanical ventilation (NIV) may reduce the need for reintubation. Among the advantages of high-flow oxygen therapy are comfort, availability, lower costs, and additional physiopathological mechanisms. 经鼻导管高流量氧疗以及无创机械通气(NIV)能够减少再次插管的需求。高流量氧疗的优点包括舒适性，容易得到，费用低廉，以及其他病理生理机制。 Objective 目的 To test if high-flow conditioned oxygen therapy is noninferior to NIV for preventing postextubation respiratory failure and reintubation in patients at high risk of reintubation. 对于再次插管的高危患者，验证高流量氧疗预防拔管后呼吸功能衰竭及再次插管的作用不劣于NIV。 Design, Setting, and Participants 设计，场景及人群 Multicenter randomized clinical trial in 3 intensive care units in Spain (September 2012-October 2014) including critically ill patients ready for planned extubation with at least 1 of the following high-risk factors for reintubation: older than 65 years; Acute Physiology and Chronic Health Evaluation II score higher than 12 points on extubation day; body mass index higher than 30; inadequate secretions management; difficult or prolonged weaning; more than 1 comorbidity; heart failure as primary indication for mechanical ventilation; moderate to severe chronic obstructive pulmonary disease; airway patency problems; or prolonged mechanical ventilation. 2012年9月至2014年10月在西班牙3个ICU进行的多中心随机临床试验，入选患者为计划拔管的危重病患者，且满足以下至少一项再次插管的高危因素：年龄超过65岁；拔管当日APACHE II评分> 12；BMI > 30；清除气道分泌物能力不充分；困难脱机或延迟脱机；超过一种合并症；心功能衰竭是机械通气的主要适应症；中重度COPD；气道完整性问题；或长期机械通气。 Interventions 干预措施 Patients were randomized to undergo either high-flow conditioned oxygen therapy or NIV for 24 hours after extubation. 患者在拔管后被随机分为高流量氧疗或NIV，疗程24小时。 Main Outcomes and Measures 主要预后指标 Primary outcomes were reintubation and postextubation respiratory failure within 72 hours. Noninferiority margin was 10 percentage points. Secondary outcomes included respiratory infection, sepsis, and multiple organ failure, length of stay and mortality; adverse events; and time to reintubation. 主要预后终点为72小时内再次插管及拔管后呼吸功能衰竭。非劣效边界为10个百分点。次要预后终点包括呼吸系统感染，全身性感染，多器官功能衰竭，住院日及住院病死率；不良事件；再次插管时间。 Results 结果 Of 604 patients (mean age, 65 [SD, 16] years; 388 [64%] men), 314 received NIV and 290 high-flow oxygen. Sixty-six patients (22.8%) in the high-flow group vs 60 (19.1%) in the NIV group did not require reintubation (absolute difference, ?3.7%; 95% CI, ?9.1% to ∞); 78 patients (26.9%) in the high-flow group vs 125 (39.8%) in the NIV group experienced postextubation respiratory failure (risk difference, 12.9%; 95% CI, 6.6% to ∞). Median time to reintubation did not significantly differ: 26.5 hours (IQR, 14-39 hours) in the high-flow group vs 21.5 hours (IQR, 10-47 hours) in the NIV group (absolute difference, ?5 hours; 95% CI, ?34 to 24 hours). Median postrandomization ICU length of stay was lower in the high-flow group, 3 days (IQR, 2-7) vs 4 days (IQR, 2-9; P=.048). Other secondary outcomes were similar in the 2 groups. Adverse effects requiring withdrawal of the therapy were observed in none of patients in the high-flow group vs 42.9% patients in the NIV group (P?<> 总共604名患者（平均年龄65 [SD 16]岁；388名[64%]为男性），314名接受NIV，290名接受高流量氧疗。高流量组66名患者(22.8%)及NIV组60名患者(19.1%)无需再次插管（绝对差异?3.7%; 95% CI, ?9.1% to ∞）；高流量组和NIV组分别有78名患者 (26.9%) 和 125 名患者 (39.8%) 发生拔管后呼吸功能衰竭（风险差异12.9%; 95% CI, 6.6% to ∞）。再次插管中位时间无显著差异：高流量组26.5小时（IQR, 14-39 小时）vs NIV组 21.5 小时（IQR, 10-47小时）（绝对差异?5 小时；95% CI, ?34 to 24 小时）。高流量组随机分组后ICU住院日中位数较短 3 天 (IQR, 2-7) vs 4 天 (IQR, 2-9; P=.048)。两组患者其他次要终点相似。高流量组发生不良反应需要终止治疗的患者数为0，而NIV组为42.9% (P?<> Conclusions and Relevance 结论及意义 Among high-risk adults who have undergone extubation, high-flow conditioned oxygen therapy was not inferior to NIV for preventing reintubation and postextubation respiratory failure. High-flow conditioned oxygen therapy may offer advantages for these patients. 对于接受拔管的高危成年患者，在预防再次插管及拔管后呼吸功能衰竭方面，高流量氧疗不劣于NIV。高流量氧疗对上述患者可能有益处。 Trial Registration 试验注册 clinicaltrials.gov Identifier: NCT01191489 |
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