None listed
Conditions
Brief summary
Distress with breathing or shortness of breath can be a debilitating experience for people suffering from lung diseases. The severity of this sensation often precludes individuals from maintaining a normal active lifestyle. As the severity of the shortness of breath increases, so the activity performed decreases, often to the point where moving from one’s bed or chair can be exhausting. The general physical and mental health consequences of this are such that these individuals and those who care for them have a significantly lower social and mental health well being. The severity of breathlessness and impairment of activity have been shown to correlate strongly with increased hospitalizations and a longer time to recovery once their condition has worsened, as in the case of exacerbations. It is hoped that a low density gas mix, such as Heliox (21 % oxygen in balance Helium), can reduce the magnitude of muscular effort associated with breathing in patients with chronic obstructive pulmonary diseases (COPD) and allow for an alteration in both the sensation and magnitude of dyspnoea allowing patients to exercise longer and at greater intensities., thus facilitating a training effect. This would allow these individuals to improve their social activity, mental health and their quality of life whilst reducing the recovery time resultant from a transient worsening of their conditions (infective exacerbations of COPD) which may have otherwise predisposed hospitalization.
Interventions
Heliox (21% oxygen in balance Helium) Heliox will only be administered during one cardio pulmonary exercise test, at a predetermined constant work rate, until exhaustion. (anticipated to be no more than 45 mins total duration). Heliox will be stored in a large non diffusing reservoir bag from where it will pass through a humidifier prior to inhalation by the patient through a face mask/mouth piece
Sponsors
Department of Respiratory Medicine, Repatriation General Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Are aged over 40 Chronic Obstructive Pulmonary Disease (COPD) of at least Stage III as per the Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines, Forced Expiratory Volume in the first second (FEV1) <= 50% predicted post bronchodilator. Are able to give informed written consent prior to entering the study. Can comply with scheduled visit and all study related activities
Exclusion criteria
Any clearly documented history of adult asthma or chronic respiratory disorders (e.g. primary bronchiectasis, pulmonary fibrosis or any clearly documented history of adult asthma or chronic respiratory disorders (e.g. primary bronchiectasis, pulmonary fibrosis, pneumoconiosis) other than COPD. Any contraindication for Cardio Pulmonary Exercise Testing (CPET), as per American Thoracic Society and American College of Chest Physicians guidelines (ATS/ACCP 2003) Participating in a research study or use of any investigational drug during this studys, pneumoconiosis) other than COPD.
Outcome results
None listed