Importance High-flow nasal oxygen may prevent postextubation respiratory failure in the intensive care unit (ICU). The combination of high-flow nasal oxygen with noninvasive ventilation (NIV) may be an optimal strategy of ventilation to avoid reintubation. Objective To determine whether high-flow nasal oxygen with prophylactic NIV applied immediately after extubation could reduce the rate of reintubation, compared with high-flow nasal oxygen alone, in patients at high risk of extubation failure in the ICU. Design, Setting, and Participants Multicenter randomized clinical trial conducted from April 2017 to January 2018 among 641 patients at high risk of extubation failure (ie, older than 65 years or with an underlying cardiac or respiratory disease) at 30 ICUs in France; follow-up was until April 2018. Interventions Patients were randomly assigned to high-flow nasal oxygen alone (n = 306) or high-flow nasal oxygen with NIV (n = 342) immediately after extubation. Main Outcomes and Measures The primary outcome was the proportion of patients reintubated at day 7; secondary outcomes included postextubation respiratory failure at day 7, reintubation rates up until ICU discharge, and ICU mortality. Results Among 648 patients who were randomized (mean [SD] age, 70 [10] years; 219 women [34%]), 641 patients completed the trial. The reintubation rate at day 7 was 11.8% (95% CI, 8.4%-15.2%) (40/339) with high-flow nasal oxygen and NIV and 18.2% (95% CI, 13.9%-22.6%) (55/302) with high-flow nasal oxygen alone (difference, -6.4% [95% CI, -12.0% to -0.9%]; P = .02). Among the 11 prespecified secondary outcomes, 6 showed no significant difference. The proportion of patients with postextubation respiratory failure at day 7 (21% vs 29%; difference, -8.7% [95% CI, -15.2% to -1.8%]; P = .01) and reintubation rates up until ICU discharge (12% vs 20%, difference -7.4% [95% CI, -13.2% to -1.8%]; P = .009) were significantly lower with high-flow nasal oxygen and NIV than with high-flow nasal oxygen alone. ICU mortality rates were not significantly different: 6% with high-flow nasal oxygen and NIV and 9% with high-flow nasal oxygen alone (difference, -2.4% [95% CI, -6.7% to 1.7%]; P = .25). Conclusions and Relevance In mechanically ventilated patients at high risk of extubation failure, the use of high-flow nasal oxygen with NIV immediately after extubation significantly decreased the risk of reintubation compared with high-flow nasal oxygen alone. Trial Registration ClinicalTrials.gov Identifier: NCT03121482.

中文翻译：

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拔管后高流量鼻氧联合无创通气与单独高流量鼻氧对拔管失败高风险患者再插管的影响

重要性 高流量鼻氧可预防重症监护病房 (ICU) 中的拔管后呼吸衰竭。高流量鼻氧与无创通气 (NIV) 的组合可能是避免再插管的最佳通气策略。目的 确定与单独使用高流量鼻氧相比，拔管后立即应用预防性 NIV 的高流量鼻氧是否可以降低 ICU 拔管失败高风险患者的再插管率。设计、设置和参与者 2017 年 4 月至 2018 年 1 月在法国 30 个 ICU 中对 641 名拔管失败高风险患者（即年龄大于 65 岁或有潜在心脏或呼吸系统疾病）进行的多中心随机临床试验；随访至 2018 年 4 月。干预措施 拔管后立即将患者随机分配到单独的高流量鼻氧（n = 306）或高流量鼻氧加 NIV（n = 342）。主要结果和措施 主要结果是第 7 天重新插管的患者比例；次要结局包括拔管后第 7 天的呼吸衰竭、ICU 出院前的再插管率和 ICU 死亡率。结果 在随机分组的 648 名患者中（平均 [SD] 年龄，70 [10] 岁；219 名女性 [34%]），641 名患者完成了试验。第 7 天的再插管率为 11.8% (95% CI, 8.4%-15.2%) (40/339) 使用高流量鼻氧和 NIV 和 18.2% (95% CI, 13.9%-22.6%) (55/ 302) 单独使用高流量鼻氧（差异，-6.4% [95% CI，-12.0% 至 -0.9%]；P = .02）。在 11 个预先指定的次要结果中，6 个没有显着差异。第 7 天拔管后呼吸衰竭患者的比例（21% 与 29%；差异，-8.7% [95% CI，-15.2% 至 -1.8%]；P = .01）和直至 ICU 出院的再插管率（ 12% 与 20%，差异 -7.4% [95% CI，-13.2% 至 -1.8%]；P = .009) 使用高流量鼻氧和 NIV 显着低于单独使用高流量鼻氧。ICU 死亡率没有显着差异：6% 使用高流量鼻氧和 NIV，9% 单独使用高流量鼻氧（差异，-2.4% [95% CI，-6.7% 至 1.7%]；P = . 25)。结论和相关性在拔管失败高风险的机械通气患者中，拔管后立即使用高流量鼻氧和 NIV 与单独使用高流量鼻氧相比，显着降低了再插管的风险。试验注册 ClinicalTrials.gov 标识符：