학술논문
Effect of Noninvasive Ventilation vs Oxygen Therapy on Mortality Among Immunocompromised Patients With Acute Respiratory Failure: A Randomized Clinical Trial
Document Type
Academic Journal
Author
Lemiale, Virginie; Mokart, Djamel; Resche-Rigon, Matthieu; Pène, Frédéric; Mayaux, Julien; Faucher, Etienne; Nyunga, Martine; Girault, Christophe; Perez, Pierre; Guitton, Christophe; Ekpe, Kenneth; Kouatchet, Achille; Théodose, Igor; Benoit, Dominique; Canet, Emmanuel; Barbier, François; Rabbat, Antoine; Bruneel, Fabrice; Vincent, Francois; Klouche, Kada; Loay, Kontar; Mariotte, Eric; Bouadma, Lila; Moreau, Anne-Sophie; Seguin, Amélie; Meert, Anne-Pascale; Reignier, Jean; Papazian, Laurent; Mehzari, Ilham; Cohen, Yves; Schenck, Maleka; Hamidfar, Rebecca; Darmon, Michael; Demoule, Alexandre; Chevret, Sylvie; Azoulay, Elie
Source
JAMA. Oct 27, 2015 314(16):1711-1719
Subject
Language
English
ISSN
0098-7484
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