ECHO ICU trial

• Research type

  Research Study

• Full 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. The E.C.H.O. ICU trial

• IRAS ID

  64487

• Contact name

  Mark W Elliott

• Sponsor organisation

  Air Liquide Santé International

• Eudract number

  2008-006173-33

• Clinicaltrials.gov Identifier

  NCT01155310

• Research summary

  The aim of the study is to investigate in severe exacerbations of COPD the efficacy of such a combined He/O2 NIV and He/O2 spontaneous breathing in reducing NIV failures (endotracheal intubation or death), as compared to the standard Air/O2 NIV and Air/O2 spontaneous breathing. Since the majority of endotracheal intubations occur within 48 hours after admission in ICU, a period of treatment of 72 hours is considered sufficient to observe differences between both treatment groups. This study will be an international, prospective, randomised, ??open-label?, comparative, parallel group study and it is planned at 18 investigational centres located in 7 countries: Belgium, France, Germany, Italy, Switzerland, Tunisia and United Kingdom. An Endpoint Validation Committee (EVC) will review, in blind, the description of the patient??s condition at intubation and will be asked to adjudicate the appropriateness of the decision of intubation.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  10/H1307/139

• Date of REC Opinion

  4 May 2011

• REC opinion

  Further Information Favourable Opinion