Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01155310
Last Updated: 2014-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
446 participants
INTERVENTIONAL
2010-05-31
2014-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Helium/Oxygen
Helium/Oxygen 78%/22% will be administered for a maximum of 72 hours.
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.
Air/Oxygen
Air/Oxygen will be administered for a maximum of 72 hours.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
35 Years
ALL
No
Sponsors
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Air Liquide Santé International
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe JOLLIET, Prof.
Role: STUDY_CHAIR
Centre Hospitalier Universitaire Vaudois
Locations
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Cliniques Universitaires Saint Luc
Brussels, , Belgium
Les Cliniques Universitaires UCL Mont Godinne
Yvoir, , Belgium
Centre Hospitalier Universitaire Angers
Angers, , France
Centre Hospitalier Universitaire Pellegrin-Tripode
Bordeaux, , France
Hôpitaux de Chartes
Chartres, , France
CHU Clermont-Ferrand - Hôpital ESTAING
Clermont-Ferrand, , France
Hôpital Henri Mondor
Créteil, , France
CHU NICE - Hopital Pasteur
Nice, , France
Hôpital Cochin
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer - Hopital Sainte Musse
Toulon, , France
Azienda Ospedaliera Univeritaria Careggi
Florence, , Italy
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Hôpital Abderrahmen Mami
Aryanah, , Tunisia
Centre Hospitalier Universitaire Fattouma Bourguiba
Monastir, , Tunisia
University Hospital of North Tees
Stockton-on-Tees, , United Kingdom
Countries
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References
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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.
Other Identifiers
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ALMED-07-C3-009
Identifier Type: -
Identifier Source: org_study_id
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