• JAMA · Oct 2015

    Randomized Controlled Trial Multicenter Study

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

    • Virginie Lemiale, Djamel Mokart, Matthieu Resche-Rigon, Frédéric Pène, Julien Mayaux, Etienne Faucher, Martine Nyunga, Christophe Girault, Pierre Perez, Christophe Guitton, Kenneth Ekpe, Achille Kouatchet, Igor Théodose, Dominique Benoit, Emmanuel Canet, François Barbier, Antoine Rabbat, Fabrice Bruneel, Francois Vincent, Kada Klouche, Kontar Loay, Eric Mariotte, Lila Bouadma, Anne-Sophie Moreau, Amélie Seguin, Anne-Pascale Meert, Jean Reignier, Laurent Papazian, Ilham Mehzari, Yves Cohen, Maleka Schenck, Rebecca Hamidfar, Michael Darmon, Alexandre Demoule, Sylvie Chevret, Elie Azoulay, and Groupe de Recherche en Réanimation Respiratoire du patient d’Onco-Hématologie (GRRR-OH).
    • Saint-Louis University Hospital, Paris, France.
    • JAMA. 2015 Oct 27; 314 (16): 1711-9.

    ImportanceNoninvasive ventilation has been recommended to decrease mortality among immunocompromised patients with hypoxemic acute respiratory failure. However, its effectiveness for this indication remains unclear.ObjectiveTo determine whether early noninvasive ventilation improved survival in immunocompromised patients with nonhypercapnic acute hypoxemic respiratory failure.Design, Setting, And ParticipantsMulticenter 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.InterventionsPatients were randomly assigned to early noninvasive ventilation (n = 191) or oxygen therapy alone (n = 183).Main Outcomes And MeasuresThe 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.ResultsAt 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 RelevanceAmong 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 Registrationclinicaltrials.gov Identifier: NCT01915719.

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