Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) (ECHO/ICU)
This study is currently recruiting participants.
Verified October 2012 by Air Liquide Santé International
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: October 3, 2012
Last verified: October 2012
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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 ]
| Estimated Enrollment: | 670 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 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
Contacts
| Contact: Joelle TEXEREAU, MD | +33 1 39 07 65 18 | joelle.texereau@airliquide.com |
| Contact: Henry TAUPIN | +33 1 39 07 62 75 | henry.taupin@airliquide.com |
Locations
| Belgium | |
| Cliniques Universitaires Saint Luc | Recruiting |
| Brussels, Belgium, 1200 | |
| Contact: Jean ROESELER + 32 2 764 27 18 jean.roeseler@uclouvain.be | |
| Principal Investigator: Jean ROESELER | |
| Les Cliniques Universitaires UCL Mont Godinne | Recruiting |
| Yvoir, Belgium, 5530 | |
| Contact: Pierre BULPA, Prof. +32 (81) 42 38 73 pierre.bulpa@uclouvain.be | |
| Principal Investigator: Pierre BULPA, Prof. | |
| France | |
| Centre Hospitalier Universitaire d'Angers | Recruiting |
| Angers, France, 49933 | |
| Contact: Alain MERCAT, Prof. + 33 2 41 35 38 15 AlMercat@chu-angers.fr | |
| Principal Investigator: Alain MERCAT, Prof. | |
| Centre Hospitalier Universitaire Pellegrin-Tripode | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Frédéric VARGAS, MD + 33 5 56 79 55 17 frederic.vargas@chu-bordeaux.fr | |
| Principal Investigator: Frédéric VARGAS, MD | |
| Hôpitaux de Chartes | Recruiting |
| Chartres, France, 28018 | |
| Contact: Pierre KALFON, MD + 33 2 37 30 30 73 pkalfon@ch-chartres.fr | |
| Principal Investigator: Pierre KALFON, MD | |
| CHU Clermont-Ferrand - Hôpital ESTAING | Not yet recruiting |
| Clermont-ferrand, France, 63003 | |
| Contact: Jean-Michel CONSTANTIN, MD +33 4 73 75 51 71 jmconstantin@chu-clermontferrand.fr | |
| Principal Investigator: jean-Michel CONSTANTIN, MD | |
| Hôpital Henri Mondor | Recruiting |
| Creteil, France, 94010 | |
| Contact: Christian BRUN-BUISSON, Prof. + 33 1 49 81 23 89 christian.brun-buisson@hmn.aphp.fr | |
| Principal Investigator: Christian BRUN-BUISSON, Prof. | |
| Hôpital de la Croix Rousse | Not yet recruiting |
| Lyon, France, 69004 | |
| Contact: Claude GUERIN, Prof. +33 4.72.07.17.62 claude.guerin@chu-lyon.fr | |
| Principal Investigator: Claude GUERIN, Prof. | |
| CHU NICE - Hopital Pasteur | Not yet recruiting |
| Nice, France, 06002 | |
| Contact: Pierre WOLTER, MD +33 4 92 03 88 83 wolter.p@chu-nice.fr | |
| Principal Investigator: Pierre WOLTER, MD | |
| Hôpital Cochin | Recruiting |
| Paris, France, 75014 | |
| Contact: Jean-Daniel CHICHE, Prof. + 33 1 58 41 25 36 jean-daniel.chiche@cch.aphp.fr | |
| Principal Investigator: Jean-Daniel CHICHE, Prof. | |
| Hôpital Européen Georges Pompidou | Recruiting |
| Paris, France, 75908 | |
| Contact: Jean-Luc DIEHL, Prof. + 33 1 56 09 32 04 jean-luc.diehl@egp.aphp.fr | |
| Principal Investigator: Jean-Luc DIEHL, Prof. | |
| Centre Hospitalier Universitaire Charles Nicolle | Not yet recruiting |
| Rouen, France, 76031 | |
| Contact: Jean-Christophe RICHARD, Prof. + 33 2 32 88 82 61 jean-christophe.richard@chu-rouen.fr | |
| Principal Investigator: Jean-Christophe RICHARD, Prof. | |
| Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer - Hopital Sainte Musse | Recruiting |
| Toulon, France, 83056 | |
| Contact: Jean-Michel ARNAL, MD + 33 4 94 14 58 90 jean-michel.arnal@ch-toulon.fr | |
| Principal Investigator: Jean-Michel ARNAL, MD | |
| Germany | |
| Klinik und Poliklinik für Innere Medizin II | Not yet recruiting |
| Donaustauf, Germany, 93093 | |
| Contact: Michael PFEIFER, Prof. + 49 9403 80215 michael.pfeifer@klinik.uni-regensburg.de | |
| Principal Investigator: Michael PFEIFER, Prof. | |
| Medizinische Hochschule | Not yet recruiting |
| Hannover, Germany, 30625 | |
| Contact: Tobias WELTE, Prof. + 49 511 532 35 31 welte.tobias@mh-hannover.de | |
| Principal Investigator: Tobias WELTE, Prof. | |
| Italy | |
| Azienda Ospedaliera Univeritaria Careggi | Recruiting |
| Firenze, Italy, 50134 | |
| Contact: Antonio CORRADO, MD + 39 05 5794 6030 corradoa@aou-careggi.toscana.it | |
| Principal Investigator: Antonio CORRADO, Prof. | |
| Policlinico Universitario A. Gemelli | Not yet recruiting |
| Roma, Italy, 00168 | |
| Contact: Massimo ANTONELLI, Prof. + 39 06 30 15 32 26 m.antonelli@rm.unicatt.it | |
| Principal Investigator: Massimo ANTONELLI, Prof. | |
| Switzerland | |
| Hôpitaux Universitaires de Genève | Recruiting |
| Genève, Switzerland, 1211 | |
| Contact: Didier TASSAUX, MD + 41 22 372 33 11 didier-tassaux@hcuge.ch | |
| Principal Investigator: Didier TASSAUX, MD | |
| Centre Hospitalier Universitaire Vaudois | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Philippe JOLLIET, Prof. + 41 21 314 20 02 philippe.jolliet@chuv.ch | |
| Principal Investigator: Philippe JOLLIET, Prof. | |
| Tunisia | |
| Hôpital Abderrahmen Mami | Recruiting |
| Ariana, Tunisia, 2080 | |
| Contact: Mohammed BESBES, Prof. + 216 71 82 14 10 mohamed.besbes@rns.tn | |
| Principal Investigator: Mohamed BESBES, Prof. | |
| Centre Hospitalier Universitaire Fattouma Bourguiba | Recruiting |
| Monastir, Tunisia, 5000 | |
| Contact: Fekri ABROUG, Prof. + 216 73 46 06 72 f.abroug@rns.tn | |
| Principal Investigator: Fekri ABROUG, Prof. | |
| United Kingdom | |
| St James's University Hospital | Not yet recruiting |
| Leeds West Yorkshire, United Kingdom | |
| Contact: Mark ELLIOTT, MD +44 (113) 206 5863 Mark.Elliott@leedsth.nhs.uk | |
| Principal Investigator: Mark ELLIOTT, MD | |
| University Hospital of North Tees | Not yet recruiting |
| Stockton on Tees, United Kingdom, TS19 8 PE | |
| Contact: Richard HARRISON, MD +44 (0) 164 262 4615 richardneil.harrison@nth.nhs.uk | |
| Principal Investigator: Richard HARRISSON, MD | |
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: | October 3, 2012 |
| 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 13, 2013