• Arnaud W Thille, Grégoire Muller, Arnaud Gacouin, Rémi Coudroy, Maxens Decavèle, Romain Sonneville, François Beloncle, Christophe Girault, Laurence Dangers, Alexandre Lautrette, Séverin Cabasson, Anahita Rouzé, Emmanuel Vivier, Anthony Le Meur, Jean-Damien Ricard, Keyvan Razazi, Guillaume Barberet, Christine Lebert, Stephan Ehrmann, Caroline Sabatier, Jeremy Bourenne, Gael Pradel, Pierre Bailly, Nicolas Terzi, Jean Dellamonica, Guillaume Lacave, Pierre-Éric Danin, Hodanou Nanadoumgar, Aude Gibelin, Lassane Zanre, Nicolas Deye, Alexandre Demoule, Adel Maamar, Mai-Anh Nay, René Robert, Stéphanie Ragot, Jean-Pierre Frat, and HIGH-WEAN Study Group and the REVA Research Network.
• Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.
• JAMA. 2019 Oct 15; 322 (15): 1465-1475.

ImportanceHigh-flow nasal oxygen may prevent postextubation respiratory failure in the intensive care unit (ICU). The combination of high-flow nasal oxygen with noninvasive ventilation (NIV) may be an optimal strategy of ventilation to avoid reintubation.ObjectiveTo determine whether high-flow nasal oxygen with prophylactic NIV applied immediately after extubation could reduce the rate of reintubation, compared with high-flow nasal oxygen alone, in patients at high risk of extubation failure in the ICU.Design, Setting, And ParticipantsMulticenter randomized clinical trial conducted from April 2017 to January 2018 among 641 patients at high risk of extubation failure (ie, older than 65 years or with an underlying cardiac or respiratory disease) at 30 ICUs in France; follow-up was until April 2018.InterventionsPatients were randomly assigned to high-flow nasal oxygen alone (n = 306) or high-flow nasal oxygen alternating with NIV (n = 342) immediately after extubation.Main Outcomes And MeasuresThe primary outcome was the proportion of patients reintubated at day 7; secondary outcomes included postextubation respiratory failure at day 7, reintubation rates up until ICU discharge, and ICU mortality.ResultsAmong 648 patients who were randomized (mean [SD] age, 70 [10] years; 219 women [34%]), 641 patients completed the trial. The reintubation rate at day 7 was 11.8% (95% CI, 8.4%-15.2%) (40/339) with high-flow nasal oxygen and NIV and 18.2% (95% CI, 13.9%-22.6%) (55/302) with high-flow nasal oxygen alone (difference, -6.4% [95% CI, -12.0% to -0.9%]; P = .02). Among the 11 prespecified secondary outcomes, 6 showed no significant difference. The proportion of patients with postextubation respiratory failure at day 7 (21% vs 29%; difference, -8.7% [95% CI, -15.2% to -1.8%]; P = .01) and reintubation rates up until ICU discharge (12% vs 20%, difference -7.4% [95% CI, -13.2% to -1.8%]; P = .009) were significantly lower with high-flow nasal oxygen and NIV than with high-flow nasal oxygen alone. ICU mortality rates were not significantly different: 6% with high-flow nasal oxygen and NIV and 9% with high-flow nasal oxygen alone (difference, -2.4% [95% CI, -6.7% to 1.7%]; P = .25).Conclusions And RelevanceIn mechanically ventilated patients at high risk of extubation failure, the use of high-flow nasal oxygen with NIV immediately after extubation significantly decreased the risk of reintubation compared with high-flow nasal oxygen alone.Trial RegistrationClinicalTrials.gov Identifier: NCT03121482.

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