COPD exacerbation - Heliox Therapy - Assessment

INTERVENTION: Trade Name: Medicinal Air Product Name: Medicinal Air Pharmaceutical Form: Inhalation gas Trade Name: Heliox21 Product Name: Heliox21 Pharmaceutical Form: Inhalation gas CONDITION: Chronic Obstructive Pulmonary Disease ; MedDRA version: 9.1 Level: LLT Classification code 10010953 Term: COPD exacerbation PRIMARY OUTCOME: Main Objective: The main objective of this pilot study is to test the trial protocol and procedures in preparation for a full‐scale study, and to estimate the patient recruitment rates at the trial centres. Primary end point(s): To evaluate the feasibility of study procedures and protocol, including the estimation of recruitment rate. Secondary Objective: To gather data on the effects of Heliox inhalation during exacerbation of COPD for the purposes of sample size calculation and trial design for a full‐scale clinical trial. The trial will collect information about blood gases (CO2, O2), blood pH,dyspnoea,vital signs, oxygenation, and nebulisation before and during treatment with a study gas (Heliox or Medical Air, with additional oxygen as required). INCLUSION CRITERIA: • Be admitted to ED with a clinical diagnosis of an acute exacerbation of COPD (acute onset of a sustained worsening of the patient’s symptoms from their usual stable state which is beyond normal day‐to‐day variations). • Have a Past Medical History of a diagnosis of COPD • Age > 40 years. • After initial nebulisation have two of: RR>30, HR>100, purulent sputum Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range