Physiological response to Heliox21 and Air O2

• Research type

  Research Study

• Full title

  Prospective randomised cross over comparison on the physiological response to non-invasive ventilation using either Air O2 or Heliox21

• IRAS ID

  9313

• Contact name

  Chris Hargreaves

• Sponsor organisation

  University College London (UCL)

• Eudract number

  2009-009599-11

• ISRCTN Number

  NA

• Research summary

  Heliox21 (Helium 21% - Oxygen 79%) is a medical gas. This has been used clinically for over 30 years to manage acute respiratory conditions. The free flowing characteristics of Heliox21 let it carry oxygen to where it is needed, even through obstructed airways. For patients with breathing difficulties, this means that the effort required to breathe can be reduced and ventilation of the lungs increased. Although Helium-Oxygen does not correct the underlying problem, it extends the period of time for treatment to take effect.We wish to establish if it is beneficial to patients who have suffered respiratory failure in an intensive care unit. We intend to compare the difference in response to breathing air-oxygen to Heliox21-oxygen after the patient has been disconnected from mechanical ventilatory support. Over a 12 month period 38 patients will be recruited from The Whittington Hospital NHS Trust. The study data will be collected in the eight hour period following disconnection from mechanical ventilation. We will construct a randomised control trial to investigate the differences between air-oxygen to Heliox21-oxygen. The study design will be a cross-over study in which the order of air-oxygen and Heliox21-oxygen will be randomised. Two groups of 19 patients will be formed:Group A:Stage 1 - 4 hours Heliox21Stage 2 - 4 hours Air O2Group B:Stage 1 - 4 hours Air O2Stage 2 - 4 hours Heliox21Patients will be blinded to the order of treatment they receive during the trial.This project is funded by the British Oxygen Corporation, the manufacturers of Heliox21.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  10/H0502/87

• Date of REC Opinion

  15 Feb 2011

• REC opinion

  Further Information Favourable Opinion