BACKGROUND The optimal strategy to prevent reintubation in obese patients remains uncertain. We aimed to determine whether noninvasive ventilation (NIV) with active humidification is superior to high-flow nasal cannula (HFNC) in preventing reintubation in obese patients at intermediate risk. METHODS Randomized controlled trial in two intensive care units in Spain (June 2020‒June 2021). We included patients ready for planned extubation with a body mass index (BMI) >30 and ≤3 risk factors for reintubation. Patients with hypercapnia at the end of the spontaneous breathing trial were excluded. Patients were randomized to undergo NIV with active humidification or HFNC for 48 hours after extubation. The primary outcome was reintubation rate within 7 days after extubation. As a secondary analysis, we performed a post hoc Bayesian analysis using three different priors. RESULTS Of 144 patients (median age, 61 [p25-p75 61-67] years; 65 [45%] men), 72 received NIV and 72 HFNC. Reintubation was required in 17 (23.6%) patients receiving NIV and in 24 (33.3%) patients receiving HFNC (difference between groups 9.7 (95%CI: -4.9 ‒ 24.4)). All the secondary analysis showed non-significant differences. In the exploratory Bayesian analysis, the probability of a reduction in reintubation with NIV was 99% (data-driven prior), 90% (minimally informative prior), or 89% (skeptical prior). CONCLUSIONS Among adult obese critically ill patients at intermediate risk for extubation failure, the rate of reintubation was not significantly lower with NIV than with HFNC. Nevertheless, there is a risk for underpowered results. Clinical trial registration available at www. CLINICALTRIALS gov, ID: NCT04125342.

中文翻译：

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湿化无创通气与高流量疗法预防肥胖患者再插管：一项随机临床试验。


背景 防止肥胖患者再次插管的最佳策略仍不确定。我们旨在确定主动湿化的无创通气 （NIV） 在预防中等风险肥胖患者再次插管方面是否优于高流量鼻插管 （HFNC）。方法 在西班牙的两个重症监护病房（2020 年 6 月至 2021 年 6 月）进行随机对照试验。我们纳入了准备计划拔管的患者，体重指数 （BMI） >30 和 ≤3 再插管危险因素。自主呼吸试验结束时的高碳酸血症患者被排除在外。患者被随机分配接受 NIV 联合主动湿化或 HFNC，持续 48 小时。主要结局是拔管后 7 天内的再插管率。作为二次分析，我们使用三个不同的先验进行了事后贝叶斯分析。结果 在 144 例患者 （中位年龄 61 [p25-p75 61-67] 岁;65 例 [45%] 男性） 中，72 例接受了 NIV，72 例接受了 HFNC。17 例 （23.6%） 接受 NIV 的患者和 24 例 （33.3%） 接受 HFNC 的患者需要再插管 （组间差异 9.7 （95% CI： -4.9 \u2012 24.4））。所有二次分析均显示无显著差异。在探索性贝叶斯分析中，NIV 再插管减少的概率为 99% （数据驱动的先验） 、 90% （信息最少的先验） 或 89% （怀疑先验）。结论 在拔管失败风险中等的成年肥胖危重症患者中，NIV 的再插管率并不显著低于 HFNC。然而，存在结果不足的风险。临床试验注册可在 www.CLINICALTRIALS gov，ID：NCT04125342。