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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Helium/Oxygen 78%/22%; Drug: Air/Oxygen

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 Type: Interventional
• Enrollment (Actual): 446
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint Luc
  • Yvoir, Belgium, 5530
    • Les Cliniques Universitaires UCL Mont Godinne
• France
  • Angers, France, 49933
    • Centre Hospitalier Universitaire Angers
  • Bordeaux, France, 33076
    • Centre Hospitalier Universitaire Pellegrin-Tripode
  • Chartres, France, 28018
    • Hôpitaux de Chartes
  • Clermont-ferrand, France, 63003
    • CHU Clermont-Ferrand - Hôpital ESTAING
  • Creteil, France, 94010
    • Hôpital Henri Mondor
  • Nice, France, 06002
    • CHU Nice - Hôpital Pasteur
  • Paris, France, 75014
    • Hôpital Cochin
  • Paris, France, 75908
    • Hôpital Européen Georges Pompidou
  • Toulon, France, 83056
    • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer - Hopital Sainte Musse
• Italy
  • Firenze, Italy, 50134
    • Azienda Ospedaliera Univeritaria Careggi
• Switzerland
  • Genève, Switzerland, 1211
    • Hôpitaux universitaires de Genève
• Tunisia
  • Ariana, Tunisia, 2080
    • Hôpital Abderrahmen Mami
  • Monastir, Tunisia, 5000
    • Centre Hospitalier Universitaire Fattouma Bourguiba
• United Kingdom
  • Stockton on Tees, United Kingdom, TS19 8 PE
    • University Hospital of North Tees

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of NIV failure	Endotracheal intubation and/or death	10 days (average)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of ICU stay and duration of index hospitalisation		10 days (average)
Duration of invasive ventilation		10 days (average)
Adverse events		6 months (post-randomization)
Medico-economic parameters	Overall costs and cost-effectiveness	6 months
Physiological and laboratory parameters	Systolic and diastolic blood pressures, heart rate, central body temperature, arterial oxygen saturation, haematology and serum biochemistry	10 days (average)
Duration of NIV sessions	Cumulative daily duration of NIV sessions and their number during each of the 3-day treatment period and globally	10 days (average)
Time interval between the discharge of the index ICU stay and the first re-admission in ICU for severe exacerbation of COPD		6 months (post-randomization)

Collaborators and Investigators

• Sponsor: Air Liquide Santé International
• Investigators: Study Chair: Philippe JOLLIET, Prof., Centre Hospitalier Universitaire Vaudois

Publications and helpful links

General Publications

• Jolliet P, Ouanes-Besbes L, Abroug F, Ben Khelil J, Besbes M, Garnero A, Arnal JM, Daviaud F, Chiche JD, Lortat-Jacob B, Diehl JL, Lerolle N, Mercat A, Razazi K, Brun-Buisson C, Durand-Zaleski I, Texereau J, Brochard L; E.C.H.O. ICU Trial Investigators. A Multicenter Randomized Trial Assessing the Efficacy of Helium/Oxygen in Severe Exacerbations of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Apr 1;195(7):871-880. doi: 10.1164/rccm.201601-0083OC. Erratum In: Am J Respir Crit Care Med. 2018 Mar 15;197(6):839-840.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 25, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (Estimate): July 1, 2010

Study Record Updates

• Last Update Posted (Estimate): October 7, 2014
• Last Update Submitted That Met QC Criteria: October 6, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: ICU; Non-Invasive Ventilation; Exacerbation of COPD; Helium/Oxygen; Patient with known or suspected COPD; patient Admitted in an ICU; Patient presenting current exacerbation of COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ALMED-07-C3-009