Arnaud W Thille1,2, Grégoire Muller3, Arnaud Gacouin4, Rémi Coudroy1,2, Maxens Decavèle5, Romain Sonneville6, François Beloncle7, Christophe Girault8, Laurence Dangers9, Alexandre Lautrette10, Séverin Cabasson11, Anahita Rouzé12, Emmanuel Vivier13, Anthony Le Meur14, Jean-Damien Ricard15, Keyvan Razazi16, Guillaume Barberet17, Christine Lebert18, Stephan Ehrmann19, Caroline Sabatier20, Jeremy Bourenne21, Gael Pradel22, Pierre Bailly23, Nicolas Terzi24, Jean Dellamonica25, Guillaume Lacave26, Pierre-Éric Danin27, Hodanou Nanadoumgar28, Aude Gibelin29, Lassane Zanre30, Nicolas Deye31, Alexandre Demoule5, Adel Maamar4, Mai-Anh Nay3, René Robert1,2, Stéphanie Ragot2, Jean-Pierre Frat1,2. 1. Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France. 2. INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France. 3. Groupe Hospitalier Régional d'Orléans, Médecine Intensive Réanimation, Orléans, France. 4. Centre Hospitalier Universitaire de Rennes, Hôpital Ponchaillou, Service des Maladies Infectieuses et Réanimation Médicale, Rennes, France. 5. Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie, Médecine Intensive et Réanimation (Département R3S), AP-HP, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Paris, France. 6. Hôpital Bichat-Claude Bernard, Médecine Intensive Réanimation, AP-HP, Université Paris Diderot, Paris, France. 7. Centre Hospitalier Universitaire d'Angers, Département de Médecine Intensive Réanimation, Université d'Angers, Angers, France. 8. Centre Hospitalier Universitaire de Rouen, Hôpital Charles Nicolle, Département de Réanimation Médicale, Normandie Université, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), Rouen, France. 9. Centre Hospitalier Universitaire Félix Guyon, Service de Réanimation Polyvalente, Saint Denis de la Réunion, France. 10. Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Réanimation Médicale, Clermont-Ferrand, France. 11. Centre Hospitalier de La Rochelle, Service de Réanimation, La Rochelle, France. 12. Centre Hospitalier Universitaire de Lille, Centre de Réanimation, Université de Lille, Lille, France. 13. Hôpital Saint-Joseph Saint-Luc, Réanimation Polyvalente, Lyon, France. 14. Centre Hospitalier Universitaire de Nantes, Médecine Intensive Réanimation, Nantes, France. 15. Hôpital Louis Mourier, Réanimation Médico-Chirurgicale, AP-HP, INSERM, Université Paris Diderot, UMR IAME 1137, Sorbonne Paris Cité, Colombes, France. 16. Hôpitaux universitaires Henri Mondor, Service de Réanimation Médicale DHU A-TVB, AP-HP, Créteil, France. 17. Groupe Hospitalier Régional Mulhouse Sud Alsace, site Emile Muller, Service de Réanimation Médicale, Mulhouse, France. 18. Centre Hospitalier Départemental de Vendée, Service de Médecine Intensive Réanimation, La Roche Sur Yon, France. 19. Centre Hospitalier Régional Universitaire de Tours, Médecine Intensive Réanimation, CIC 1415, Réseau CRICS-Trigger SEP, Centre d'étude des pathologies respiratoires, INSERM U1100, Université de Tours, Tours, France. 20. Centre Hospitalier de Pau, Service de Réanimation, Pau, France. 21. Centre Hospitalier Universitaire La Timone 2, Médecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, Marseille, France. 22. Centre Hospitalier Henri Mondor d'Aurillac, Service de Réanimation, Aurillac, France. 23. Centre Hospitalier Universitaire de Brest, Médecine Intensive Réanimation, Brest, France. 24. Centre Hospitalier Universitaire Grenoble Alpes, Médecine Intensive Réanimation, INSERM, Université Grenoble-Alpes, U1042, HP2, Grenoble, France. 25. Centre Hospitalier Universitaire de Nice, Médecine Intensive Réanimation, Archet 1, Université Cote d'Azur, Nice, France. 26. Centre Hospitalier de Versailles, Service de Réanimation Médico-Chirurgicale, Le Chesnay, France. 27. Centre Hospitalier Universitaire de Nice, Réanimation Médico-Chirurgicale Archet 2, INSERM U 1065, Nice, France. 28. Centre Hospitalier Universitaire de Poitiers, Réanimation Chirurgicale, Poitiers, France. 29. Hôpital Tenon, Réanimation et USC médico-chirurgicale, CARMAS, AP-HP, Faculté de médecine Sorbonne Université, Collegium Galilée, Paris, France. 30. Centre Hospitalier Emile Roux, Service de Réanimation, Le Puy en Velay, France. 31. Hôpital Lariboisière, Réanimation Médicale et Toxicologique, AP-HP, INSERM UMR-S 942, Paris, France.
Abstract
Importance: High-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. Objective: To 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 Participants: Multicenter 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. Interventions: Patients 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 Measures: The 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. Results: Among 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 Relevance: In 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 Registration: ClinicalTrials.gov Identifier: NCT03121482.
RCT Entities:
Importance: High-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. Objective: To 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 Participants: Multicenter 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. Interventions: Patients 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 Measures: The 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. Results: Among 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 Relevance: In 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 Registration: ClinicalTrials.gov Identifier: NCT03121482.
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