None listed
Conditions
Brief summary
This study will investigate the effect of the AIRVO device (high flow nasal therapy) on the blood levels of carbon dioxide (PaCO2) in participants with stable chronic obstructive pulmonary disease (COPD). Acute exacerbations of this condition cause a build-up of carbon dioxide in the blood which can require ventilation and increase risk of death. Acute exacerbations of COPD lead to 9000 hospital admissions in New Zealand every year. High flow nasal therapy has a potential role in lowering carbon dioxide levels in COPD patients and we therefore wish to study the effects further. Participants will undergo an informed consent process, gathering of personal/medical information and lung function testing. They will then be randomised to the order they receive 4 interventions for 20 minutes at a time and a ‘washout’ period of 15 minutes after each. The AIRVO device will be used to deliver air for 3 interventions at different flow rates. The 4th intervention will be 20mins of the participant breathing room air whilst being monitored. The participant will be asked to complete a tolerability questionnaire following each 20 minute intervention with the AIRVO. The primary aim of the study is to identify whether the AIRVO device has an impact on PaCO2 levels in participants. Secondary outcomes include how well participants tolerate the AIRVO machine and other physical parameters such as respiratory rate, oxygen saturations, minute ventilation and heart rate.
Interventions
There will be three AIRVO interventions each lasting 20 minutes. These will involve breathing heated and humidified room air through the AIRVO nasal interface (nasal prongs which sit inside both nostrils). Three different flow rates will be used: 45L/min, 30L/min and 15L/min.
A 15 minute 'washout' period will follow each intervention. During this time the subject will breathe room air without any breathing apparatus.
Note: The 45 L/min intervention will have 30 seconds of delivery at 30L/min at
There will be three AIRVO interventions each lasting 20 minutes. These will involve breathing heated and humidified room air through the AIRVO nasal interface (nasal prongs which sit inside both nostrils). Three different flow rates will be used: 45L/min, 30L/min and 15L/min. A 15 minute 'washout' period will follow each intervention. During this time the subject will breathe room air without any breathing apparatus. Note: The 45 L/min intervention will have 30 seconds of delivery at 30L/min at the beginning to allow the participant to more comfortably get used to the subsequent 45 L/min level.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A doctor’s diagnosis of COPD 2. Age greater than or equal to 40 years
Exclusion criteria
1. Smoking pack year history <10 years 2. FEV1/FVC >70% 3. Long term oxygen therapy 4. COPD not deemed to be ‘stable’: a. Current exacerbation requiring acute treatment with short course antibiotic/oral steroid or oxygen therapy. b. Hospital admission for an acute exacerbation of COPD in the last 6 weeks. 5. Nasal conditions such as deviated septum, chronic rhinitis, current cold/flu which, in the evaluation by the investigator, could impair nasal breathing. 6. Any other condition, which at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or study results.
Outcome results
None listed