Clinical trial NCT01155310: Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: 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
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 446
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction of NIV failure
timeFrame: 10 days (average)
Secondary outcomes:
measure: Duration of ICU stay and duration of index hospitalisation
timeFrame: 10 days (average)
measure: Duration of invasive ventilation
timeFrame: 10 days (average)
measure: Adverse events
timeFrame: 6 months (post-randomization)
measure: Medico-economic parameters
timeFrame: 6 months
measure: Physiological and laboratory parameters
timeFrame: 10 days (average)
measure: Duration of NIV sessions
timeFrame: 10 days (average)
measure: Time interval between the discharge of the index ICU stay and the first re-admission in ICU for severe exacerbation of COPD
timeFrame: 6 months (post-randomization)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Yvoir
country: Belgium
facility: Les Cliniques Universitaires UCL Mont Godinne
city: Angers
country: France
facility: Centre Hospitalier Universitaire Angers
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire Pellegrin-Tripode
city: Chartres
country: France
facility: Hôpitaux de Chartes
city: Clermont-ferrand
country: France
facility: CHU Clermont-Ferrand - Hôpital ESTAING
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Nice
country: France
facility: CHU NICE - Hopital Pasteur
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer - Hopital Sainte Musse
city: Firenze
country: Italy
facility: Azienda Ospedaliera Univeritaria Careggi
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Ariana
country: Tunisia
facility: Hôpital Abderrahmen Mami
city: Monastir
country: Tunisia
facility: Centre Hospitalier Universitaire Fattouma Bourguiba
city: Stockton on Tees
country: United Kingdom
facility: University Hospital of North Tees
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Philippe JOLLIET, Prof.
role: STUDY_CHAIR
References:
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.