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Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

2014-07-23 21:08:34 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Chronic Obstructive Pulmonary Disease

Intervention

Helium/Oxygen 78%/22%, Air/Oxygen

Location

Cliniques Universitaires Saint Luc
Brussels
Belgium
1200

Status

Recruiting

Source

Air Liquide Santé International

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:34-0400

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