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A multicenter, randomized trial of noninvasive ventilation with helium-oxygen mixture in exacerbations of chronic obstructive lung disease*

Maggiore, Salvatore Maurizio MD, PhD; Richard, Jean-Christophe M. MD, PhD; Abroug, Fekri MD; Diehl, Jean Luc MD; Antonelli, Massimo MD; Sauder, Philippe MD; Mancebo, Jordi MD; Ferrer, Miquel MD; Lellouche, Francois MD, PhD; Lecourt, Laurent Pharm D; Beduneau, Gaetan MD; Brochard, Laurent MD

doi: 10.1097/CCM.0b013e3181b78abe
Clinical Investigations

Objective: To assess the effect of a helium-oxygen mixture on intubation rate and clinical outcomes during noninvasive ventilation in acute exacerbation of chronic obstructive pulmonary disease.

Design: Multicenter, prospective, randomized, controlled trial.

Setting: Seven intensive care units.

Patients: A total of 204 patients with known or suspected chronic obstructive pulmonary disease and acute dyspnea, Paco2> 45 mm Hg and two among the following factors: pH <7.35, Paco2 <50 mm Hg, respiratory rate >25/min.

Interventions: Noninvasive ventilation randomly applied with or without helium (inspired oxygen fraction 0.35) via a face mask.

Measurements and Main Results: Duration and complications of NIV and mechanical ventilation, endotracheal intubation, discharge from intensive care unit and hospital, mortality at day 28, adverse and serious adverse events were recorded. Follow-up lasted until 28 days since enrollment. Intubation rate did not significantly differ between groups (24.5% vs. 30.4% with or without helium, p = .35). No difference was observed in terms of improvement of arterial blood gases, dyspnea, and respiratory rate between groups. Duration of noninvasive ventilation, length of stay, 28-day mortality, complications and adverse events were similar, although serious adverse events tended to be lower with helium (10.8% vs. 19.6%, p = .08).

Conclusions: Despite small trends favoring helium, this study did not show a statistical superiority of using helium during NIV to decrease the intubation rate in acute exacerbation of chronic obstructive pulmonary disease.

From the Department of Anesthesiology and Intensive Care (SMM, MA), Agostino Gemelli University Hospital, Università Cattolica del Sacro Cuore, Rome, Italy; Medical Intensive Care Unit (SMM, FL, LB), AP-HP, Henri Mondor Hospital, Créteil, France; Medical Intensive Care Unit (J-CMR, GB), Charles Nicolle University Hospital, Rouen, France; UPRES 38 30 (J-CMR), Rouen University, Rouen, France; Intensive Care Unit (FA), F. Bourguiba University Hospital, Monastir, Tunisia; Medical Intensive Care Unit (JLD), Georges Pompidou University Hospital, Paris, France; Medical Intensive Care Unit (PS), Hospices Civiles Hospital, Strasbourg, France; Intensive Care Unit (JM), San Pau University Hospital, Barcelona, Spain; Respiratory Intensive Care Unit (MF), Clinical Institute of Pneumology and Thoracic Surgery, Clinic University Hospital, Barcelona, Spain; Research Department (LL), Air Liquide Santé International, Paris, France; Université Paris 12 (LB), Créteil, France; INSERM U 955 (LB), Créteil, France.

This work was supported, in part, by Air Liquide Santé International.

Drs. Maurizio Maggiore and Richard contributed equally to this work.

Dr. Brochard's laboratory has received grant support from Air Liquide Santé International. Dr. Lecourt has been employed at Air Liquide Santé. The remaining authors have not disclosed any potential conflicts of interest.

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© 2010 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins