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:
Air Liquide Santé International
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01155310
First received: June 25, 2010
Last updated: June 18, 2013
Last verified: June 2013
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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: | January 2014 |
| Estimated 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
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: | June 18, 2013 |
| 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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013