Humidified Noninvasive Ventilation versus High-Flow Therapy to Prevent Reintubation in Patients with Obesity: A Randomized Clinical Trial.

Objectives: We aimed to determine whether noninvasive ventilation (NIV) with active humidification is superior to a high-flow nasal cannula (HFNC) in preventing reintubation in patients with obesity at intermediate risk.

目标：我们旨在确定对于中度风险的肥胖患者，使用主动湿化的无创通气（NIV）是否比高流量鼻导管（HFNC）更能有效预防再次插管。

Methods: We conducted a randomized controlled trialin two ICUs in Spain (June 2020-June 2021).

方法：我们在西班牙的两个重症监护室进行了随机对照试验（2020年6月至2021年6月）。

We included patients ready for planned extubation with a body mass index >30 and three or fewer risk factors for reintubation.

我们纳入了准备进行计划性拔管、体重指数>30且再插管风险因素不超过三个的患者。

Patients with hypercapnia at the end of the spontaneous breathing trial were excluded.

在自发呼吸试验结束时存在高碳酸血症的患者被排除在外。

Patients were randomized to undergo NIV with active humidification or HFNC for 48 hours after extubation.

患者在拔管后随机接受带有主动湿化的NIV或HFNC治疗48小时。

The primary outcome was the reintubation rate within 7 days after extubation.

主要结果是拔管后7天内的重新插管率。

As a secondary analysis, we performed a post hoc Bayesian analysis using three different priors.

作为次要分析，我们使用三种不同的先验进行了事后贝叶斯分析。

Measurements and Main Results: Of 144 patients (median age, 61 [25th-75th percentile range, 61-67] yr; 65 [45%] men), 72 received NIV and 72 received an HFNC.

测量和主要结果：144名患者（中位年龄61岁[四分位数范围，61-67岁]；65名[45%]为男性），其中72名接受了NIV治疗，另外72名接受了HFNC治疗。

Reintubation was required in 17 (23.6%) patients receiving NIV and in 24 (33.3%) patients receiving HFNC (difference between groups, 9.7; 95% confidence interval, -4.9, 24.4).

需要重新插管的患者在NIV组有17名（23.6%），在HFNC组有24名（33.3%）（两组差异为9.7；95%置信区间为-4.9, 24.4）。

All of the secondary analysis showed nonsignificant differences.

所有次要分析显示差异不显著。

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).

在探索性贝叶斯分析中，使用NIV减少重新插管的概率为99%（数据驱动的先验概率）、90%（最小信息先验概率）或89%（怀疑先验概率）。

Conclusions: Among adult critically ill patients with obesity at intermediate risk for extubation failure, the rate of reintubation was not significantly lower with NIV than with HFNC.

结论：在中度拔管失败风险的肥胖成年危重病患者中，使用无创通气(NIV)的再插管率与高流量鼻导管通气(HFNC)相比，并没有显著降低。

Nevertheless, there is a risk for underpowered results.

然而，存在结果功效不足的风险。

Clinical trial registered with www.clinicaltrials.gov (NCT04125342).

临床试验已在www.clinicaltrials.gov注册（NCT04125342）。