Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial
Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial
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DOI：
10.1001/jama.2019.14901
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发表时间：
2019-10-15
影响因子：
120.7
通讯作者：
Buscot, Matthieu
中科院分区：
文献类型：
--
作者：
Thille, Arnaud W.;Muller, Gregoire;Buscot, Matthieu
关键问题在有高拔管失败风险的机械通气患者中，与单独使用高流量鼻氧相比，拔管后使用高流量鼻氧和无创通气是否可以降低再次插管的风险？在这项包括641名患者的随机临床试验中，与仅使用高流量鼻氧相比，高流量鼻氧配合无创呼吸机显著降低了拔管后7天内的再插管率(11.8%比18.2%)。在拔管失败的高危患者中，与仅使用高流量鼻氧相比，拔管后使用高流量鼻氧配合无创呼吸机可显著降低再次插管的风险。高流量鼻氧与无创通气(NIV)相结合可能是避免再次插管的最佳通气策略。目的探讨在ICU拔管失败高危患者拔管后立即应用高流量鼻氧和预防性NIV是否能降低再插管率(与单纯高流量鼻氧相比)。设计、设置和参与者2017年4月至2018年1月在法国30个ICU对641名有拔管失败高危风险(即65岁以上或有潜在心脏或呼吸系统疾病)的患者进行了多中心随机临床试验；随访至2018年4月。干预方法将患者随机分为两组，分别在拔管后即刻给予高流量鼻氧组(306例)和高流量鼻氧组(342例)。主要结果和测量主要结果是第7天重新插管的患者比例；次要结果包括第7天拔管后呼吸衰竭、直到ICU出院的再插管率和ICU死亡率。结果在随机选择的648名患者中(平均年龄70[10]岁；219名女性[34%])，641名患者完成了试验。高流量鼻氧组和单纯鼻氧组第7天再插管率分别为11.8%(95%CI，8.4%~15.2%)和18.2%(95%CI，13.9%~22.6%)(40/339)(P=0.02)。在11个预先指定的次级结局中，6个没有显著差异。高流量鼻氧组患者拔管后第7天发生呼吸衰竭的比例(21%比29%；差值-8.7%[95%CI，-15.2%比-1.8%]；P=0.01)和ICU出院前再插管率(12%比20%，差值-7.4%[95%CI，-13.2%比-1.8%]；P=0.009)。ICU病死率无显著差异：高流量鼻氧组和NIV组病死率分别为6%和9%(差异，-2.4%[95%CI，-6.7%比1.7%]；P=0.25)。结论和相关性在拔管失败风险较高的机械通气患者中，拔管后立即使用高流量鼻氧和NIV比单独使用高流量鼻氧显著降低再插管风险。试验登记：ClinicalTrials.gov标识：NCT03121482这项随机临床试验比较了在重症监护病房(ICU)拔管失败的高危患者中，在拔管后立即应用高流量鼻氧和预防性无创呼吸机与单独使用高流量鼻氧对再插管率的影响。
Key PointsQuestionAmong mechanically ventilated patients at high risk of extubation failure, does the use of high-flow nasal oxygen with noninvasive ventilation after extubation reduce the risk of reintubation compared with high-flow nasal oxygen alone? FindingsIn this randomized clinical trial that included 641 patients, high-flow nasal oxygen with noninvasive ventilation, compared with high-flow nasal oxygen alone, significantly decreased the rate of reintubation within the first 7 days after extubation (11.8% vs 18.2%). MeaningIn patients at high risk of extubation failure, the use of high-flow nasal oxygen with noninvasive ventilation after extubation significantly decreased the risk of reintubation compared with high-flow nasal oxygen alone.ImportanceHigh-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. ObjectiveTo 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 ParticipantsMulticenter 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. InterventionsPatients 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 MeasuresThe 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. ResultsAmong 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 RelevanceIn 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 RegistrationClinicalTrials.gov Identifier: NCT03121482This randomized clinical trial compares the effect of high-flow nasal oxygen with prophylactic noninvasive ventilation applied immediately after extubation vs high-flow nasal oxygen alone on the rate of reintubation in patients at high risk of extubation failure in the intensive care unit (ICU).