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The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2) 78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.
Patients eligible for this study are critically ill patients with COPD admitted in Intensive Care Unit for an exacerbation of their chronic disease with hypercapnic acute respiratory failure. The patients will receive an Helium/Oxygen mixture or an Air/Oxygen mixture for a maximum of 72 hours during Non-Invasive Ventilation (NIV) and NIV-free sessions.
During NIV sessions, gas mixtures will be administered using a ventilator suitable for NIV with either He/O2 or Air/O2 and a NIV facemask.
Patients will be followed until hospital discharge and then contacted by phone up to the 6th month after randomization.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
Helium/Oxygen 78%/22%, Air/Oxygen
Cliniques Universitaires Saint Luc
Air Liquide Santé International
Published on BioPortfolio: 2014-07-23T21:08:34-0400
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