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High-Flow Versus VenturiMask Oxygen Therapy to Prevent Reintubation in Hypoxemic Patients after Extubation: A Multicenter Randomized Clinical Trial.
American Journal of Respiratory and Critical Care Medicine ( IF 19.3 ) Pub Date : 2022-12-15 , DOI: 10.1164/rccm.202201-0065oc
Salvatore Maurizio Maggiore 1, 2 , Samir Jaber 3, 4 , Domenico Luca Grieco 5 , Jordi Mancebo 6 , Spyros Zakynthinos 7 , Alexandre Demoule 8, 9 , Jean-Damien Ricard 10 , Paolo Navalesi 11 , Rosanna Vaschetto 12, 13 , Sami Hraiech 14 , Kada Klouche 15, 16 , Jean-Pierre Frat 17, 18 , Virginie Lemiale 19 , Vito Fanelli 20, 21 , Gerald Chanques 3, 4 , Daniele Natalini 4 , Eleni Ischaki 6 , Danielle Reuter 8, 9 , Indalecio Morán 5 , Béatrice La Combe 8 , Federico Longhini 22 , Andrea De Gaetano 23, 24 , V Marco Ranieri 25 , Laurent J Brochard 26, 27 , Massimo Antonelli 4 ,
Affiliation  

Rationale: When compared with VenturiMask after extubation, high-flow nasal oxygen provides physiological advantages. Objectives: To establish whether high-flow oxygen prevents endotracheal reintubation in hypoxemic patients after extubation, compared with VenturiMask. Methods: In this multicenter randomized trial, 494 patients exhibiting PaO2:FiO2 ratio ⩽ 300 mm Hg after extubation were randomly assigned to receive high-flow or VenturiMask oxygen, with the possibility to apply rescue noninvasive ventilation before reintubation. High-flow use in the VenturiMask group was not permitted. Measurements and Main Results: The primary outcome was the rate of reintubation within 72 hours according to predefined criteria, which were validated a posteriori by an independent adjudication committee. Main secondary outcomes included reintubation rate at 28 days and the need for rescue noninvasive ventilation according to predefined criteria. After intubation criteria validation (n = 492 patients), 32 patients (13%) in the high-flow group and 27 patients (11%) in the VenturiMask group required reintubation at 72 hours (unadjusted odds ratio, 1.26 [95% confidence interval (CI), 0.70-2.26]; P = 0.49). At 28 days, the rate of reintubation was 21% in the high-flow group and 23% in the VenturiMask group (adjusted hazard ratio, 0.89 [95% CI, 0.60-1.31]; P = 0.55). The need for rescue noninvasive ventilation was significantly lower in the high-flow group than in the VenturiMask group: at 72 hours, 8% versus 17% (adjusted hazard ratio, 0.39 [95% CI, 0.22-0.71]; P = 0.002) and at 28 days, 12% versus 21% (adjusted hazard ratio, 0.52 [95% CI, 0.32-0.83]; P = 0.007). Conclusions: Reintubation rate did not significantly differ between patients treated with VenturiMask or high-flow oxygen after extubation. High-flow oxygen yielded less frequent use of rescue noninvasive ventilation. Clinical trial registered with www.clinicaltrials.gov (NCT02107183).

中文翻译:

高流量与 VenturiMask 氧疗预防拔管后低氧血症患者的再插管:一项多中心随机临床试验。

理由:与拔管后的 VenturiMask 相比,高流量经鼻吸氧具有生理优势。目的:与 VenturiMask 相比,确定高流量氧气是否能防止拔管后低氧患者的气管内再插管。方法:在这项多中心随机试验中,494 名拔管后 PaO2:FiO2 比率≤300 mm Hg 的患者被随机分配接受高流量或 VenturiMask 氧气治疗,并有可能在再插管前应用抢救性无创通气。VenturiMask 组不允许高流量使用。测量和主要结果:主要结果是 72 小时内根据预定义标准重新插管的比率,该标准由独立裁决委员会事后验证。主要次要结局包括 28 天时的再插管率和根据预定义标准进行抢救无创通气的需要。插管标准验证后(n = 492 名患者),高流量组中的 32 名患者 (13%) 和 VenturiMask 组中的 27 名患者 (11%) 需要在 72 小时内重新插管(未调整的比值比,1.26 [95% 置信区间) (CI), 0.70-2.26];P = 0.49)。28 天时,高流量组的再插管率为 21%,VenturiMask 组为 23%(调整后的风险比为 0.89 [95% CI,0.60-1.31];P = 0.55)。高流量组对抢救无创通气的需求明显低于 VenturiMask 组:72 小时时,8% 对 17%(调整后的风险比,0.39 [95% CI,0.22-0.71];P = 0.002)在 28 天时,12% 对 21%(调整后的风险比,0.52 [95% CI,0.32-0.83];P = 0.007)。结论:拔管后接受 VenturiMask 或高流量氧气治疗的患者的再插管率无显着差异。高流量氧气减少了救援无创通气的使用频率。在 www.clinicaltrials.gov (NCT02107183) 注册的临床试验。
更新日期:2022-07-18
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