Status:
TERMINATED
Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Air Liquide Santé International
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief 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 pati...
Detailed 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 pati...
Eligibility Criteria
Inclusion
- Patient with known or suspected COPD
- Patient presenting current exacerbation of COPD with hypercapnic acute respiratory failure
- Patient eligible for Non-Invasive Ventilation (NIV)
- Patient admitted in an ICU
Exclusion
- Patient who had lung transplant
- Patient having a contraindication to NIV
- Patient with tracheostomy
- Patient requiring Oxygen flow rate \> 6 L/min or Inspired Oxygen Fraction (FIO2) \> 0.50
- Patient admitted in the ICU for more than 24 hours and/or having received NIV in ICU for more than 6 hours (in total) for the current exacerbation of COPD
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT01155310
Start Date
May 1 2010
End Date
June 1 2014
Last Update
October 7 2014
Active Locations (16)
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1
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
2
Les Cliniques Universitaires UCL Mont Godinne
Yvoir, Belgium, 5530
3
Centre Hospitalier Universitaire Angers
Angers, France, 49933
4
Centre Hospitalier Universitaire Pellegrin-Tripode
Bordeaux, France, 33076