Pilot CHeTA COPD exacerbation - Heliox Therapy - Assessment

• Research type

  Research Study

• Full title

  Pilot CHeTA - COPD exacerbation Heliox Therapy Assessment

• Sponsor organisation

  BOC Ltd

• Eudract number

  2008-005660-13

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a prospective, randomised, controlled pilot study, to test the trial procedures, to estimate patient recruitment and to gather data on the effects of Heliox inhalation during the management of exacerbation of COPD for the purposes of sample size calculation and trial design for a full-scale clinical trial.All patients admitted to hospital with an exacerbation of COPD, who satisfy the entry criteria, will be asked to go through the informed consent procedure. If informed consent is given, the patient will be randomised to receive either Heliox21 or medical air gas therapy alongside standard hospital treatment for COPD. The target sample size is a total of 24 patients, 12 patients per treatment group.Patients will receive the study gas for two hours via a tight fitting mask, using a Heliox-compatible ventilator. During this time normal management with the required oxygen, nebulisations and other medications will be administered. Oxygen saturation, transcutaneous CO2, respiratory rate and fraction of inspired oxygen will be monitored continuously. Dyspnoea, heart rate, blood pressure, temperature, medications and any adverse events will be recorded every 20 minutes. Arterial blood sampling will take place hourly for blood gas analysis. A venous sample will be taken at the start of the study for full blood analysis.After the two hours of study treatment, the gas therapy will stop and the patient will revert to conventional management with additional oxygen, as required, delivered by facemask or nasal cannula.There will be a one hour follow-up period after stopping the gas therapy. During this time, data will be recorded for adverse events, heart rate, respiratory rate, oxygen saturation, required oxygenation and medications. Also, a safety assessment will be carried out twenty four hours after stopping the trial gas.

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  08/H0403/130

• Date of REC Opinion

  11 Dec 2008

• REC opinion

  Further Information Favourable Opinion