Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients A Randomized Clinical Trial
Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients A Randomized Clinical Trial
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DOI：
10.1001/jama.2016.14194
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发表时间：
2016-10-18
影响因子：
120.7
通讯作者：
Fernandez, Rafael
中科院分区：
文献类型：
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作者：
Hernandez, Gonzalo;Vaquero, Concepcion;Fernandez, Rafael
重要性通过鼻插管和无创机械通气（NIV）提供的高流量条件氧疗可减少重新插管的需要。高流量氧疗的优点包括舒适性、可用性、低成本和额外的生理病理机制。目的：检测高流量条件氧疗在预防高风险再插管患者拔管后呼吸衰竭和再插管方面是否不劣于NIV。在西班牙3个重症监护病房进行的多中心随机临床试验（2012年9月至2014年10月），包括准备按计划拔管的危重患者，至少有以下一项重新插管的高风险因素：65岁以上;拔管当天急性生理学和慢性健康评估II评分高于12分;体重指数高于30;分泌物管理不足;脱机困难或延长; 1种以上合并症;心力衰竭作为机械通气的主要适应症;中度至重度慢性阻塞性肺疾病;气道通畅问题;干预患者随机接受高流量条件氧治疗或NIV拔管后24 hours.MAIN OUTCOMES AND MEASURES主要结果是再插管和拔管后72小时内呼吸衰竭。非劣效性界值为10个百分点。次要结果包括呼吸道感染、败血症和多器官衰竭、住院时间和死亡率、不良事件和再插管时间。结果在604例患者中（平均年龄65岁，男性388例，占64%），314例接受NIV治疗，290例接受高流量氧气治疗。66名患者高流量组为22.8%，NIV组中有19.1%的患者不需要重新插管（绝对差异，-3.7%; 95% CI，-9.1%至无穷大）; 78例患者高流量组为26.9%，（39.8%）发生拔管后呼吸衰竭（风险差异，12.9%; 95% CI，6.6%至无穷大）。中位再插管时间无显著差异：高流量组为26.5小时（IQR，14-39小时），NIV组为21.5小时（IQR，10-47小时）（绝对差异，-5小时; 95% CI，-34至24小时）。高流量组随机化后ICU住院时间中位数较低，3天（IQR，2-7）vs 4天（IQR，2-9; P=. 048）。两组的其他次要结局相似。高流量组无一例患者出现需要停药的不良反应，而NIV组有42.9%的患者出现了需要停药的不良反应（P
IMPORTANCE 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.OBJECTIVE 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.DESIGN, SETTING, AND PARTICIPANTS 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.INTERVENTIONS Patients were randomized to undergo either high-flow conditioned oxygen therapy or NIV for 24 hours after extubation.MAIN OUTCOMES AND MEASURES 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.RESULTS 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 infinity); 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 infinity). 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