Hospital Virgen de la Salud, Toledo, Spain.
Hospital Universitario Ramón y Cajal, Madrid, Spain.
JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
Studies of mechanically ventilated critically ill patients that combine populations that are at high and low risk for reintubation suggest that conditioned high-flow nasal cannula oxygen therapy after extubation improves oxygenation compared with conventional oxygen therapy. However, conclusive data about reintubation are lacking.
To determine whether high-flow nasal cannula oxygen therapy is superior to conventional oxygen therapy for preventing reintubation in mechanically ventilated patients at low risk for reintubation.
DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized clinical trial conducted between September 2012 and October 2014 in 7 intensive care units (ICUs) in Spain. Participants were 527 adult critical patients at low risk for reintubation who fulfilled criteria for planned extubation. Low risk for reintubation was defined as younger than 65 years; Acute Physiology and Chronic Health Evaluation II score less than 12 on day of extubation; body mass index less than 30; adequate secretions management; simple weaning; 0 or 1 comorbidity; and absence of heart failure, moderate-to-severe chronic obstructive pulmonary disease, airway patency problems, and prolonged mechanical ventilation.
Patients were randomized to undergo either high-flow or conventional oxygen therapy for 24 hours after extubation.
The primary outcome was reintubation within 72 hours, compared with the Cochran-Mantel-Haenszel χ2 test. Secondary outcomes included postextubation respiratory failure, respiratory infection, sepsis and multiorgan failure, ICU and hospital length of stay and mortality, adverse events, and time to reintubation.
Of 527 patients (mean age, 51 years [range, 18-64]; 62% men), 264 received high-flow therapy and 263 conventional oxygen therapy. Reintubation within 72 hours was less common in the high-flow group (13 patients [4.9%] vs 32 [12.2%] in the conventional group; absolute difference, 7.2% [95% CI, 2.5% to 12.2%]; P = .004). Postextubation respiratory failure was less common in the high-flow group (22/264 patients [8.3%] vs 38/263 [14.4%] in the conventional group; absolute difference, 6.1% [95% CI, 0.7% to 11.6%]; P = .03). Time to reintubation was not significantly different between groups (19 hours [interquartile range, 12-28] in the high-flow group vs 15 hours [interquartile range, 9-31] in the conventional group; absolute difference, -4 [95% CI, -54 to 46]; P = .66]. No adverse effects were reported.
Among extubated patients at low risk for reintubation, the use of high-flow nasal cannula oxygen compared with conventional oxygen therapy reduced the risk of reintubation within 72 hours.
clinicaltrials.gov Identifier: NCT01191489.
对处于高风险和低风险重新插管的机械通气危重症患者进行的研究表明，与常规氧疗相比，拔管后使用条件性高流量鼻导管氧疗可改善氧合。然而，关于重新插管的结论性数据仍然缺乏。
确定高流量鼻导管氧疗是否优于常规氧疗，以预防低重新插管风险的机械通气患者重新插管。
设计、地点和参与者：这是一项在西班牙 7 个 ICU 于 2012 年 9 月至 2014 年 10 月进行的多中心随机临床试验。参与者为 527 名低重新插管风险的成年危重症患者，符合计划拔管标准。低重新插管风险定义为年龄小于 65 岁；拔管日急性生理学和慢性健康评估 II 评分小于 12；体重指数小于 30；有适当的排痰管理；简单的撤机；0 或 1 种合并症；不存在心力衰竭、中重度慢性阻塞性肺疾病、气道通畅问题和长时间机械通气。
患者在拔管后随机接受高流量或常规氧疗 24 小时。
主要结局为 72 小时内重新插管，比较采用 Cochran-Mantel-Haenszel χ2 检验。次要结局包括拔管后呼吸衰竭、呼吸感染、脓毒症和多器官衰竭、ICU 和住院时间及死亡率、不良事件和重新插管时间。
527 名患者（平均年龄 51 岁[范围，18-64 岁]；62%为男性）中，264 名接受高流量治疗，263 名接受常规氧疗。高流量组 72 小时内重新插管的患者较少（13 例[4.9%]比常规组 32 例[12.2%]；绝对差值，7.2%[95%CI，2.5%至 12.2%]；P = .004）。高流量组拔管后呼吸衰竭的患者较少（22/264 例[8.3%]比常规组 38/263 例[14.4%]；绝对差值，6.1%[95%CI，0.7%至 11.6%]；P = .03）。两组间重新插管时间无显著差异（高流量组 19 小时[四分位距，12-28]，常规组 15 小时[四分位距，9-31]；绝对差值，-4[95%CI，-54 至 46]；P = .66）。未报告不良事件。
在低重新插管风险的拔管患者中，与常规氧疗相比，使用高流量鼻导管氧疗可降低 72 小时内重新插管的风险。
clinicaltrials.gov 标识符：NCT01191489。
