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- Title
Effect of Noninvasive Ventilation vs Oxygen Therapy on Mortality Among Immunocompromised Patients With Acute Respiratory Failure: A Randomized Clinical Trial.
- Authors
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
- Abstract
<bold>Importance: </bold>Noninvasive ventilation has been recommended to decrease mortality among immunocompromised patients with hypoxemic acute respiratory failure. However, its effectiveness for this indication remains unclear.<bold>Objective: </bold>To determine whether early noninvasive ventilation improved survival in immunocompromised patients with nonhypercapnic acute hypoxemic respiratory failure.<bold>Design, Setting, and Participants: </bold>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.<bold>Interventions: </bold>Patients were randomly assigned to early noninvasive ventilation (n = 191) or oxygen therapy alone (n = 183).<bold>Main Outcomes and Measures: </bold>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.<bold>Results: </bold>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.<bold>Conclusions and Relevance: </bold>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.<bold>Trial Registration: </bold>clinicaltrials.gov Identifier: NCT01915719.
- Subjects
BELGIUM; FRANCE; RESPIRATORY insufficiency treatment; ARTIFICIAL respiration; HYPOXEMIA; CROSS infection; CAUSES of death; INTENSIVE care units; INTUBATION; OXYGEN therapy; RESPIRATORY insufficiency; TIME; ACUTE diseases; IMMUNOCOMPROMISED patients; THERAPEUTICS
- Publication
JAMA: Journal of the American Medical Association, 2015, Vol 314, Issue 16, p1711
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2015.12402