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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Helium/Oxygen 78%/22%
Air/Oxygen
Sponsored by
Air Liquide Santé International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring 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

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques Universitaires Saint Luc
  • Les Cliniques Universitaires UCL Mont Godinne
  • Centre Hospitalier Universitaire Angers
  • Centre Hospitalier Universitaire Pellegrin-Tripode
  • Hôpitaux de Chartes
  • CHU Clermont-Ferrand - Hôpital ESTAING
  • Hôpital Henri Mondor
  • CHU NICE - Hopital Pasteur
  • Hôpital Cochin
  • Hôpital Européen Georges Pompidou
  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer - Hopital Sainte Musse
  • Azienda Ospedaliera Univeritaria Careggi
  • Hôpitaux Universitaires de Genève
  • Hôpital Abderrahmen Mami
  • Centre Hospitalier Universitaire Fattouma Bourguiba
  • University Hospital of North Tees

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Helium/Oxygen

Air/Oxygen

Arm Description

Helium/Oxygen 78%/22% will be administered for a maximum of 72 hours.

Air/Oxygen will be administered for a maximum of 72 hours.

Outcomes

Primary Outcome Measures

Reduction of NIV failure
Endotracheal intubation and/or death

Secondary Outcome Measures

Duration of ICU stay and duration of index hospitalisation
Duration of invasive ventilation
Adverse events
Medico-economic parameters
Overall costs and cost-effectiveness
Physiological and laboratory parameters
Systolic and diastolic blood pressures, heart rate, central body temperature, arterial oxygen saturation, haematology and serum biochemistry
Duration of NIV sessions
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

Full Information

First Posted
June 25, 2010
Last Updated
October 6, 2014
Sponsor
Air Liquide Santé International
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1. Study Identification

Unique Protocol Identification Number
NCT01155310
Brief Title
Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Acronym
ECHO/ICU
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
the observed event rate is lower than expected by the protocol hypothesis.
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide Santé International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
446 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Helium/Oxygen
Arm Type
Experimental
Arm Description
Helium/Oxygen 78%/22% will be administered for a maximum of 72 hours.
Arm Title
Air/Oxygen
Arm Type
Active Comparator
Arm Description
Air/Oxygen will be administered for a maximum of 72 hours.
Intervention Type
Drug
Intervention Name(s)
Helium/Oxygen 78%/22%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Air/Oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of NIV failure
Description
Endotracheal intubation and/or death
Time Frame
10 days (average)
Secondary Outcome Measure Information:
Title
Duration of ICU stay and duration of index hospitalisation
Time Frame
10 days (average)
Title
Duration of invasive ventilation
Time Frame
10 days (average)
Title
Adverse events
Time Frame
6 months (post-randomization)
Title
Medico-economic parameters
Description
Overall costs and cost-effectiveness
Time Frame
6 months
Title
Physiological and laboratory parameters
Description
Systolic and diastolic blood pressures, heart rate, central body temperature, arterial oxygen saturation, haematology and serum biochemistry
Time Frame
10 days (average)
Title
Duration of NIV sessions
Description
Cumulative daily duration of NIV sessions and their number during each of the 3-day treatment period and globally
Time Frame
10 days (average)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe JOLLIET, Prof.
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Study Chair
Facility Information:
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Les Cliniques Universitaires UCL Mont Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre Hospitalier Universitaire Pellegrin-Tripode
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpitaux de Chartes
City
Chartres
ZIP/Postal Code
28018
Country
France
Facility Name
CHU Clermont-Ferrand - Hôpital ESTAING
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU NICE - Hopital Pasteur
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer - Hopital Sainte Musse
City
Toulon
ZIP/Postal Code
83056
Country
France
Facility Name
Azienda Ospedaliera Univeritaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Hôpitaux Universitaires de Genève
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Hôpital Abderrahmen Mami
City
Ariana
ZIP/Postal Code
2080
Country
Tunisia
Facility Name
Centre Hospitalier Universitaire Fattouma Bourguiba
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
University Hospital of North Tees
City
Stockton on Tees
ZIP/Postal Code
TS19 8 PE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27736154
Citation
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.
Results Reference
derived

Learn more about this trial

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

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