Effect of Noninvasive Ventilation vs Oxygen Therapy on Mortality Among Immunocompromised Patients With Acute Respiratory Failure: A Randomized Clinical Trial

• Published in: JAMA : the journal of the American Medical Association 2015-10, Vol.314 (16), p.1711-1719
• Main 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, 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
• Format: Article
• Language: English
• Subjects: Acute Disease; Aged; Belgium; Cause of Death; Cross Infection; Female; France; Humans; Hypoxia - mortality; Hypoxia - therapy; Immunocompromised Host; Intensive care; Intensive Care Units; Intubation - utilization; Male; Middle Aged; Mortality; Noninvasive Ventilation - mortality; Oxygen Inhalation Therapy - mortality; Oxygen therapy; Respiration; Respiratory Insufficiency - mortality; Respiratory Insufficiency - therapy; Time Factors; Ventilation
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.2015.12402

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