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Original Investigation
Caring for the Critically Ill Patient
October 27, 2015

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

Author Affiliations
  • 1Saint-Louis University Hospital, Paris, France
  • 2IPC, Lyon, France
  • 3APHP, Paris, France
  • 4Service de Pneumologie Et Réanimation Médicale, AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Paris, France
  • 5Hospices Civils de Lyon, Lyon, France
  • 6Roubaix, Roubaix, France
  • 7Medical Intensive Care Unit, Charles Nicolle University Hospital-Rouen University, Rouen, France
  • 8Centre Hospitalier Universitaire-Nancy, Nancy, France
  • 9University Hospital of Nantes, Nantes, France
  • 10The Institut Gustave-Roussy (IGR), France
  • 11Intensive Care Unit, CHRU Angers, Angers, France
  • 12Intensive Care Medicine, Ghent, Gent, Belgium
  • 13Medical Intensive Care Unit, La Source Hospital-CHR Orleans, Orléans, France
  • 14Intensive Care Unit, Hopital Andre Mignot-Le Chesnay, Paris, France
  • 15Hôpital d'Avicenne, APHP, Bobigny, France
  • 16Lapeyronie University Hospital, Montpellier, France
  • 17Centre Hospitalier Universitaire-Amiens, Amiens, France
  • 18Centre de Réanimation, CHRU Lille, Lille, France
  • 19Centre Hospitalier Universitaire-Caen, Caen, France
  • 20Institut Jules Bordet, Brussels, Belgium
  • 21Réanimation Médicale, Centre Hospitalier Universitaire-Nantes, Nantes, France
  • 22Réanimation DRIS, Hopital Nord, Marseille, France
  • 23Centre Hospitalier Sud Francilien (CHSF), France
  • 24The Hôpital civil de Strasbourg, Strasbourg, France
  • 25The Centre Hospitalier Universitaire de Grenoble, Grenoble, France
  • 26Medical-Surgical ICU, Saint-Etienne University Hospital, Saint-Etienne, France
JAMA. 2015;314(16):1711-1719. 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