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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:
  • Reduction of NIV failure [ Time Frame: 10 days (average) ] [ Designated as safety issue: No ]
    Endotracheal intubation and/or death


Secondary Outcome Measures:
  • 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 ]

Enrollment: 446
Study Start Date: May 2010
Estimated Study Completion Date: June 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Helium/Oxygen
Helium/Oxygen 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.


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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155310

Locations
Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Les Cliniques Universitaires UCL Mont Godinne
Yvoir, Belgium, 5530
France
Centre Hospitalier Universitaire d'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 Européen Georges Pompidou
Paris, France, 75908
Hôpital Cochin
Paris, France, 75014
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
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
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
Study Chair: Philippe JOLLIET, Prof. Centre hospitalier universitaire vaudois, Lausanne, Switzerland
  More Information

No publications provided

Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT01155310     History of Changes
Other Study ID Numbers: ALMED-07-C3-009
Study First Received: June 25, 2010
Last Updated: February 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
United Kingdom: National Health Service
Tunisia: Ministry of Public Health
Switzerland: Swissmedic

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:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014