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

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ClinicalTrials.gov Identifier: NCT01155310
Recruitment Status : Terminated (the observed event rate is lower than expected by the protocol hypothesis.)
First Posted : July 1, 2010
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Air Liquide Santé International

Study Description
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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 patients with severe hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Helium/Oxygen 78%/22% Drug: Air/Oxygen Phase 3

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 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An International Phase III Randomised Trial Comparing in Severe Exacerbations of Chronic Obstructive Pulmonary Disease the Efficacy of Helium/Oxygen Versus Air/Oxygen Administered During Spontaneous Breathing and Intermittent Non-Invasive Ventilation.
Study Start Date : May 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Helium/Oxygen
Helium/Oxygen 78%/22% will be administered for a maximum of 72 hours.
 Drug: Helium/Oxygen 78%/22%

The Helium/Oxygen mixture will be administered during NIV and NIV-free sessions for a maximum of 72 hours using study dedicated devices.

Patients will then receive the Air/Oxygen mixture with usual devices.
Active Comparator: Air/Oxygen
Air/Oxygen will be administered for a maximum of 72 hours.
 Drug: Air/Oxygen

The Helium/Oxygen mixture will be administered during NIV and NIV-free sessions for a maximum of 72 hours using study dedicated devices.

Patients will then receive the Air/Oxygen mixture with usual devices.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of NIV failure [ Time Frame: 10 days (average) ]
    Endotracheal intubation and/or death


Secondary Outcome Measures :
  1. Duration of ICU stay and duration of index hospitalisation [ Time Frame: 10 days (average) ]
  2. Duration of invasive ventilation [ Time Frame: 10 days (average) ]
  3. Adverse events [ Time Frame: 6 months (post-randomization) ]
  4. Medico-economic parameters [ Time Frame: 6 months ]
    Overall costs and cost-effectiveness

  5. Physiological and laboratory parameters [ Time Frame: 10 days (average) ]
    Systolic and diastolic blood pressures, heart rate, central body temperature, arterial oxygen saturation, haematology and serum biochemistry

  6. Duration of NIV sessions [ Time Frame: 10 days (average) ]
    Cumulative daily duration of NIV sessions and their number during each of the 3-day treatment period and globally

  7. Time interval between the discharge of the index ICU stay and the first re-admission in ICU for severe exacerbation of COPD [ Time Frame: 6 months (post-randomization) ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155310


Locations
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Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Les Cliniques Universitaires UCL Mont Godinne
Yvoir, Belgium, 5530
France
Centre Hospitalier Universitaire Angers
Angers, France, 49933
Centre Hospitalier Universitaire Pellegrin-Tripode
Bordeaux, France, 33076
Hôpitaux de Chartes
Chartres, France, 28018
CHU Clermont-Ferrand - Hôpital ESTAING
Clermont-ferrand, France, 63003
Hôpital Henri Mondor
Creteil, France, 94010
CHU NICE - Hopital Pasteur
Nice, France, 06002
Hôpital Cochin
Paris, France, 75014
Hôpital Européen Georges Pompidou
Paris, France, 75908
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer - Hopital Sainte Musse
Toulon, France, 83056
Italy
Azienda Ospedaliera Univeritaria Careggi
Firenze, Italy, 50134
Switzerland
Hôpitaux Universitaires de Genève
Genève, Switzerland, 1211
Tunisia
Hôpital Abderrahmen Mami
Ariana, Tunisia, 2080
Centre Hospitalier Universitaire Fattouma Bourguiba
Monastir, Tunisia, 5000
United Kingdom
University Hospital of North Tees
Stockton on Tees, United Kingdom, TS19 8 PE
Sponsors and Collaborators
Air Liquide Santé International
Investigators
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Study Chair: Philippe JOLLIET, Prof. Centre Hospitalier Universitaire Vaudois
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT01155310    
Other Study ID Numbers: ALMED-07-C3-009
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014
Keywords provided by Air Liquide Santé International:
Exacerbation of COPD
Helium/Oxygen
ICU
Non-Invasive Ventilation
 Patient with known or suspected COPD
patient Admitted in an ICU
Patient presenting current exacerbation of COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes