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

This study has suspended participant recruitment.
(the observed event rate is lower than expected by the protocol hypothesis, in accordance with recent publications in similar patients populations.)
Sponsor:
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01155310
First received: June 25, 2010
Last updated: February 10, 2014
Last verified: February 2014

June 25, 2010
February 10, 2014
May 2010
October 2013   (final data collection date for primary outcome measure)
Reduction of NIV failure [ Time Frame: 10 days (average) ] [ Designated as safety issue: No ]
Endotracheal intubation and/or death
Same as current
Complete list of historical versions of study NCT01155310 on ClinicalTrials.gov Archive Site
  • Duration of ICU stay and duration of index hospitalisation [ Time Frame: 10 days (average) ] [ Designated as safety issue: No ]
  • Duration of invasive ventilation [ Time Frame: 10 days (average) ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 6 months (post-randomization) ] [ Designated as safety issue: Yes ]
  • Medico-economic parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Overall costs and cost-effectiveness
  • Physiological and laboratory parameters [ Time Frame: 10 days (average) ] [ Designated as safety issue: Yes ]
    Systolic and diastolic blood pressures, heart rate, central body temperature, arterial oxygen saturation, haematology and serum biochemistry
  • Duration of NIV sessions [ Time Frame: 10 days (average) ] [ Designated as safety issue: No ]
    Cumulative daily duration of NIV sessions and their number during each of the 3-day treatment period and globally
  • 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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • 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.

  • 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.

  • Experimental: Helium/Oxygen
    Helium/Oxygen will be administered for a maximum of 72 hours.
    Intervention: Drug: Helium/Oxygen 78%/22%
  • Active Comparator: Air/Oxygen
    Air/Oxygen will be administered for a maximum of 72 hours.
    Intervention: Drug: Air/Oxygen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
446
June 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Italy,   Switzerland,   Tunisia,   United Kingdom
 
NCT01155310
ALMED-07-C3-009
No
Air Liquide Santé International
Air Liquide Santé International
Not Provided
Study Chair: Philippe JOLLIET, Prof. Centre hospitalier universitaire vaudois, Lausanne, Switzerland
Air Liquide Santé International
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP