Virginie Lemiale1, Djamel Mokart2, Matthieu Resche-Rigon3, Frédéric Pène3, Julien Mayaux4, Etienne Faucher5, Martine Nyunga6, Christophe Girault7, Pierre Perez8, Christophe Guitton9, Kenneth Ekpe10, Achille Kouatchet11, Igor Théodose3, Dominique Benoit12, Emmanuel Canet3, François Barbier13, Antoine Rabbat3, Fabrice Bruneel14, Francois Vincent15, Kada Klouche16, Kontar Loay17, Eric Mariotte3, Lila Bouadma3, Anne-Sophie Moreau18, Amélie Seguin19, Anne-Pascale Meert20, Jean Reignier21, Laurent Papazian22, Ilham Mehzari23, Yves Cohen15, Maleka Schenck24, Rebecca Hamidfar25, Michael Darmon26, Alexandre Demoule3, Sylvie Chevret1, Elie Azoulay1. 1. Saint-Louis University Hospital, Paris, France. 2. IPC, Lyon, France. 3. APHP, Paris, France. 4. Service de Pneumologie Et Réanimation Médicale, AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Paris, France. 5. Hospices Civils de Lyon, Lyon, France. 6. Roubaix, Roubaix, France. 7. Medical Intensive Care Unit, Charles Nicolle University Hospital-Rouen University, Rouen, France. 8. Centre Hospitalier Universitaire-Nancy, Nancy, France. 9. University Hospital of Nantes, Nantes, France. 10. The Institut Gustave-Roussy (IGR), France. 11. Intensive Care Unit, CHRU Angers, Angers, France. 12. Intensive Care Medicine, Ghent, Gent, Belgium. 13. Medical Intensive Care Unit, La Source Hospital-CHR Orleans, Orléans, France. 14. Intensive Care Unit, Hopital Andre Mignot-Le Chesnay, Paris, France. 15. Hôpital d'Avicenne, APHP, Bobigny, France. 16. Lapeyronie University Hospital, Montpellier, France. 17. Centre Hospitalier Universitaire-Amiens, Amiens, France. 18. Centre de Réanimation, CHRU Lille, Lille, France. 19. Centre Hospitalier Universitaire-Caen, Caen, France. 20. Institut Jules Bordet, Brussels, Belgium. 21. Réanimation Médicale, Centre Hospitalier Universitaire-Nantes, Nantes, France. 22. Réanimation DRIS, Hopital Nord, Marseille, France. 23. Centre Hospitalier Sud Francilien (CHSF), France. 24. The Hôpital civil de Strasbourg, Strasbourg, France. 25. The Centre Hospitalier Universitaire de Grenoble, Grenoble, France. 26. Medical-Surgical ICU, Saint-Etienne University Hospital, Saint-Etienne, France.
Abstract
IMPORTANCE: Noninvasive ventilation has been recommended to decrease mortality among immunocompromised patients with hypoxemic acute respiratory failure. However, its effectiveness for this indication remains unclear. OBJECTIVE: To determine whether early noninvasive ventilation improved survival in immunocompromised patients with nonhypercapnic acute hypoxemic respiratory failure. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized trial conducted among 374 critically ill immunocompromised patients, of whom 317 (84.7%) were receiving treatment for hematologic malignancies or solid tumors, at 28 intensive care units (ICUs) in France and Belgium between August 12, 2013, and January 2, 2015. INTERVENTIONS: Patients were randomly assigned to early noninvasive ventilation (n = 191) or oxygen therapy alone (n = 183). MAIN OUTCOMES AND MEASURES: The primary outcome was day-28 mortality. Secondary outcomes were intubation, Sequential Organ Failure Assessment score on day 3, ICU-acquired infections, duration of mechanical ventilation, and ICU length of stay. RESULTS: At randomization, median oxygen flow was 9 L/min (interquartile range, 5-15) in the noninvasive ventilation group and 9 L/min (interquartile range, 6-15) in the oxygen group. All patients in the noninvasive ventilation group received the first noninvasive ventilation session immediately after randomization. On day 28 after randomization, 46 deaths (24.1%) had occurred in the noninvasive ventilation group vs 50 (27.3%) in the oxygen group (absolute difference, -3.2 [95% CI, -12.1 to 5.6]; P = .47). Oxygenation failure occurred in 155 patients overall (41.4%), 73 (38.2%) in the noninvasive ventilation group and 82 (44.8%) in the oxygen group (absolute difference, -6.6 [95% CI, -16.6 to 3.4]; P = .20). There were no significant differences in ICU-acquired infections, duration of mechanical ventilation, or lengths of ICU or hospital stays. CONCLUSIONS AND RELEVANCE: Among immunocompromised patients admitted to the ICU with hypoxemic acute respiratory failure, early noninvasive ventilation compared with oxygen therapy alone did not reduce 28-day mortality. However, study power was limited. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01915719.
RCT Entities:
IMPORTANCE: Noninvasive ventilation has been recommended to decrease mortality among immunocompromised patients with hypoxemic acute respiratory failure. However, its effectiveness for this indication remains unclear. OBJECTIVE: To determine whether early noninvasive ventilation improved survival in immunocompromised patients with nonhypercapnic acute hypoxemic respiratory failure. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized trial conducted among 374 critically ill immunocompromised patients, of whom 317 (84.7%) were receiving treatment for hematologic malignancies or solid tumors, at 28 intensive care units (ICUs) in France and Belgium between August 12, 2013, and January 2, 2015. INTERVENTIONS:Patients were randomly assigned to early noninvasive ventilation (n = 191) or oxygen therapy alone (n = 183). MAIN OUTCOMES AND MEASURES: The primary outcome was day-28 mortality. Secondary outcomes were intubation, Sequential Organ Failure Assessment score on day 3, ICU-acquired infections, duration of mechanical ventilation, and ICU length of stay. RESULTS: At randomization, median oxygen flow was 9 L/min (interquartile range, 5-15) in the noninvasive ventilation group and 9 L/min (interquartile range, 6-15) in the oxygen group. All patients in the noninvasive ventilation group received the first noninvasive ventilation session immediately after randomization. On day 28 after randomization, 46 deaths (24.1%) had occurred in the noninvasive ventilation group vs 50 (27.3%) in the oxygen group (absolute difference, -3.2 [95% CI, -12.1 to 5.6]; P = .47). Oxygenation failure occurred in 155 patients overall (41.4%), 73 (38.2%) in the noninvasive ventilation group and 82 (44.8%) in the oxygen group (absolute difference, -6.6 [95% CI, -16.6 to 3.4]; P = .20). There were no significant differences in ICU-acquired infections, duration of mechanical ventilation, or lengths of ICU or hospital stays. CONCLUSIONS AND RELEVANCE: Among immunocompromised patients admitted to the ICU with hypoxemic acute respiratory failure, early noninvasive ventilation compared with oxygen therapy alone did not reduce 28-day mortality. However, study power was limited. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01915719.
Authors: Samir Jaber; Giacomo Bellani; Lluis Blanch; Alexandre Demoule; Andrés Esteban; Luciano Gattinoni; Claude Guérin; Nicholas Hill; John G Laffey; Salvatore Maurizio Maggiore; Jordi Mancebo; Paul H Mayo; Jarrod M Mosier; Paolo Navalesi; Michael Quintel; Jean Louis Vincent; John J Marini Journal: Intensive Care Med Date: 2017-08-07 Impact factor: 17.440
Authors: Elie Azoulay; Peter Schellongowski; Michael Darmon; Philippe R Bauer; Dominique Benoit; Pieter Depuydt; Jigeeshu V Divatia; Virginie Lemiale; Maarten van Vliet; Anne-Pascale Meert; Djamel Mokart; Stephen M Pastores; Anders Perner; Frédéric Pène; Peter Pickkers; Kathryn A Puxty; Francois Vincent; Jorge Salluh; Ayman O Soubani; Massimo Antonelli; Thomas Staudinger; Michael von Bergwelt-Baildon; Marcio Soares Journal: Intensive Care Med Date: 2017-07-19 Impact factor: 17.440