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

NCT01155310 | Terminated Phase 3

• 1 other identifier: ALMED-07-C3-009
• Study Type: interventional
• Target: 446
• Locations: 6 countries
• Sites: 16

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.

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

Outcome Measures

Primary Outcomes (1)

• Reduction of NIV failure

  Endotracheal intubation and/or death

  10 days (average)

Secondary Outcomes (7)

• Duration of ICU stay and duration of index hospitalisation

  10 days (average)

• Duration of invasive ventilation

  10 days (average)

• Adverse events

  6 months (post-randomization)

• Medico-economic parameters

  6 months

• Physiological and laboratory parameters

  10 days (average)

Study Arms (2)

Helium/Oxygen

EXPERIMENTAL

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

Drug: Helium/Oxygen 78%/22%

Air/Oxygen

ACTIVE COMPARATOR

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

Drug: Air/Oxygen

Interventions

Helium/Oxygen 78%/22% DRUG

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.

Helium/Oxygen

Air/Oxygen DRUG

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

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Liquide Santé International: lead

Study Sites (16)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Les Cliniques Universitaires UCL Mont Godinne

Yvoir, 5530, Belgium

Location

Centre Hospitalier Universitaire Angers

Angers, 49933, France

Location

Centre Hospitalier Universitaire Pellegrin-Tripode

Bordeaux, 33076, France

Location

Hôpitaux de Chartes

Chartres, 28018, France

Location

CHU Clermont-Ferrand - Hôpital ESTAING

Clermont-Ferrand, 63003, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU NICE - Hopital Pasteur

Nice, 06002, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer - Hopital Sainte Musse

Toulon, 83056, France

Location

Azienda Ospedaliera Univeritaria Careggi

Florence, 50134, Italy

Location

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

Hôpital Abderrahmen Mami

Aryanah, 2080, Tunisia

Location

Centre Hospitalier Universitaire Fattouma Bourguiba

Monastir, 5000, Tunisia

Location

University Hospital of North Tees

Stockton-on-Tees, TS19 8 PE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27736154 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Helium; Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases; Chalcogens

Study Officials

• Philippe JOLLIET, Prof.

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: July 1, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: June 1, 2014
• Last Updated: October 7, 2014

Record last verified: 2014-10

Locations

IT (1); CH (1); BE (2); TU (2); FR (9); GB (1)