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Effect of noninvasive ventilation vs oxygen therapy on mortality among immunocompromised patients with acute respiratory failure: a randomized clinical trial

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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.
Keywords
CRITICALLY-ILL PATIENTS, INTENSIVE-CARE-UNIT, PROSPECTIVE MULTICENTER DATA, DISTRESS-SYNDROME, MECHANICAL VENTILATION, ONCOLOGY PATIENTS, HEMATOLOGY, SURVIVAL, CANCER, MALIGNANCIES

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Chicago
Lemiale, Virginie, Djamel Mokart, Matthieu Resche-Rigon, Frédéric Pène, Julien Mayaux, Etienne Faucher, Martine Nyunga, et al. 2015. “Effect of Noninvasive Ventilation Vs Oxygen Therapy on Mortality Among Immunocompromised Patients with Acute Respiratory Failure: a Randomized Clinical Trial.” Jama-journal of the American Medical Association 314 (16): 1711–1719.
APA
Lemiale, V., Mokart, D., Resche-Rigon, M., Pène, F., Mayaux, J., Faucher, E., Nyunga, M., et al. (2015). Effect of noninvasive ventilation vs oxygen therapy on mortality among immunocompromised patients with acute respiratory failure: a randomized clinical trial. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 314(16), 1711–1719.
Vancouver
1.
Lemiale V, Mokart D, Resche-Rigon M, Pène F, Mayaux J, Faucher E, et al. Effect of noninvasive ventilation vs oxygen therapy on mortality among immunocompromised patients with acute respiratory failure: a randomized clinical trial. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. 2015;314(16):1711–9.
MLA
Lemiale, Virginie et al. “Effect of Noninvasive Ventilation Vs Oxygen Therapy on Mortality Among Immunocompromised Patients with Acute Respiratory Failure: a Randomized Clinical Trial.” JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 314.16 (2015): 1711–1719. Print.
@article{7100705,
  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.},
  author       = {Lemiale, Virginie and Mokart, Djamel and Resche-Rigon, Matthieu and P{\`e}ne, Fr{\'e}d{\'e}ric and Mayaux, Julien and Faucher, Etienne and Nyunga, Martine and Girault, Christophe and Perez, Pierre and Guitton, Christophe and Ekpe, Kenneth and Kouatchet, Achille and Th{\'e}odose, Igor and Benoit, Dominique and Canet, Emmanuel and Barbier, Fran\c{c}ois and Rabbat, Antoine and Bruneel, Fabrice and Vincent, Fran\c{c}ois and Klouche, Kada and Loay, Kontar and Mariotte, Eric and Bouadma, Lila and Moreau, Anne-Sophie and Seguin, Am{\'e}lie and Meert, Anne-Pascale and Reignier, Jean and Papazian, Laurent and Mehzari, Ilham and Cohen, Yves and Schenck, Maleka and Hamidfar, Rebecca and Darmon, Michael and Demoule, Alexandre and Chevret, Sylvie and Azoulay, Elie},
  issn         = {0098-7484},
  journal      = {JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION},
  language     = {eng},
  number       = {16},
  pages        = {1711--1719},
  title        = {Effect of noninvasive ventilation vs oxygen therapy on mortality among immunocompromised patients with acute respiratory failure: a randomized clinical trial},
  url          = {http://dx.doi.org/10.1001/jama.2015.12402},
  volume       = {314},
  year         = {2015},
}

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