Department of Anaesthesia and Intensive Care unit, Regional University Hospital of Montpellier, St-Eloi Hospital, University of Montpellier, PhyMedExp, INSERM U1046, CNRS UMR, 9214, Montpellier, CEDEX 5, France.
CHU Lille, Réanimation Chirurgicale, F-59000, France.
Lancet Respir Med. 2023 Jun;11(6):530-539. doi: 10.1016/S2213-2600(22)00529-X. Epub 2023 Jan 21.
Non-invasive ventilation (NIV) and oxygen therapy (high-flow nasal oxygen [HFNO] or standard oxygen) following extubation have never been compared in critically ill patients with obesity. We aimed to compare NIV (alternating with HFNO or standard oxygen) and oxygen therapy (HFNO or standard oxygen) following extubation of critically ill patients with obesity.
In this multicentre, parallel group, pragmatic randomised controlled trial, conducted in 39 intensive care units in France, critically ill patients with obesity undergoing extubation were randomly assigned (1:1) to either the NIV group or the oxygen therapy group. Two randomisations were performed: first, randomisation to either NIV or oxygen therapy, and second, randomisation to either HFNO or standard oxygen (also 1:1), which was nested within the first randomisation. Blinding of the randomisation was not possible, but the statistician was masked to group assignment. The primary outcome was treatment failure within 3 days after extubation, a composite of reintubation for mechanical ventilation, switch to the other study treatment, or premature discontinuation of study treatment. The primary outcome was analysed by intention to treat. Effect of medical and surgical status was assessed. The reintubation within 3 days was analysed by intention to treat and after a post-hoc crossover analysis. This study is registered with ClinicalTrials.gov, number NCT04014920.
From Oct 2, 2019, to July 17, 2021, of the 1650 screened patients, 981 were enrolled. Treatment failure occurred in 66 (13·5%) of 490 patients in the NIV group and in 130 (26·5%) of 491 patients in the oxygen-therapy group (relative risk 0·43; 95% CI 0·31-0·60, p<0·0001). Medical or surgical status did not modify the effect of NIV group on the treatment-failure rate. Reintubation within 3 days after extubation was similar in the non-invasive ventilation group and in the oxygen therapy group in the intention-to-treat analysis (48 (10%) of 490 patients and 59 (12%) of 491 patients, p=0·26) and lower in the NIV group than in the oxygen-therapy group in the post-hoc cross-over (51 (9%) of 560 patients and 56 (13%) of 421 patients, p=0·037) analysis. No severe adverse events were reported.
Among critically ill adults with obesity undergoing extubation, the use of NIV was effective to reduce treatment-failure within 3 days. Our results are relevant to clinical practice, supporting the use of NIV after extubation of critically ill patients with obesity. However, most of the difference in the primary outcome was due to patients in the oxygen therapy group switching to NIV, and more evidence is needed to conclude that an NIV strategy leads to improved patient-centred outcomes.
French Ministry of Health.
在肥胖危重症患者中，气管拔管后使用无创通气（NIV）和氧疗（高流量鼻氧疗[HFNO]或标准氧疗）从未进行过比较。我们旨在比较肥胖危重症患者气管拔管后使用 NIV（交替使用 HFNO 或标准氧疗）和氧疗（HFNO 或标准氧疗）的效果。
这是一项在法国 39 家重症监护病房进行的多中心、平行组、实用随机对照试验，纳入了肥胖行气管拔管的危重症患者，将其随机（1:1）分配至 NIV 组或氧疗组。进行了两次随机分组：首先，随机分组至 NIV 或氧疗组，其次，随机分组至 HFNO 或标准氧疗组（同样为 1:1），嵌套于第一次随机分组中。无法对随机分组进行盲法，但统计师对分组情况设盲。主要结局为气管拔管后 3 天内的治疗失败，包括因机械通气而重新插管、切换至另一种研究治疗或提前停止研究治疗的复合结局。主要结局采用意向治疗进行分析。评估了医疗和手术状态的影响。气管拔管后 3 天内的再插管情况采用意向治疗和事后交叉分析进行分析。该研究在 ClinicalTrials.gov 注册，编号为 NCT04014920。
从 2019 年 10 月 2 日至 2021 年 7 月 17 日，在筛选的 1650 名患者中，981 名患者入组。NIV 组 490 名患者中有 66 名（13.5%）和氧疗组 491 名患者中有 130 名（26.5%）发生治疗失败（相对风险 0.43；95%CI 0.31-0.60，p<0.0001）。医疗或手术状态并未改变 NIV 组对治疗失败率的影响。气管拔管后 3 天内的再插管情况在意向治疗分析中，NIV 组与氧疗组相似（490 名患者中有 48 名[10%]和 491 名患者中有 59 名[12%]，p=0.26），但在事后交叉分析中，NIV 组低于氧疗组（560 名患者中有 51 名[9%]和 421 名患者中有 56 名[13%]，p=0.037）。未报告严重不良事件。
在肥胖行气管拔管的成年危重症患者中，使用 NIV 可有效降低 3 天内的治疗失败率。我们的结果与临床实践相关，支持在肥胖危重症患者气管拔管后使用 NIV。然而，主要结局的大部分差异归因于氧疗组的患者转而使用 NIV，需要更多证据来确定 NIV 策略是否能改善以患者为中心的结局。
法国卫生部。
