None listed
Conditions
Brief summary
The Airvo device has been developed to provide oxygen at high flow rates with positive airway pressure. It is not known, however, how this method of delivery influences carbon dioxide levels in patients at risk of oxygen induced hypercapnia, such as those with chronic obstructive pulmonary disease. To understand clinical utility and safety, it is crucial to determine how supplementary oxygen administered by the Airvo device influences the carbon dioxide and compare this with similar oxygen concentrations delivered by low flow nasal cannulae.
Interventions
Oxygen administered via the Airvo device at the setting of 25 Litres per minute, titrated to achieve a target participant oxygen saturation of 96%, over a period of 30 minutes. This will be followed by a 15 minute washout period.
Oxygen administered via the Airvo device at the setting of 45 Litres per minute, titrated to achieve a target participant oxygen saturation of 96%, over a period of 30 minutes. This will be followed by a 15 minute washout period.
Note prior to the above, tolerability
Oxygen administered via the Airvo device at the setting of 25 Litres per minute, titrated to achieve a target participant oxygen saturation of 96%, over a period of 30 minutes. This will be followed by a 15 minute washout period. Oxygen administered via the Airvo device at the setting of 45 Litres per minute, titrated to achieve a target participant oxygen saturation of 96%, over a period of 30 minutes. This will be followed by a 15 minute washout period. Note prior to the above, tolerability to the Airvo will be tested at 25 Litres per minute for 15 minutes, followed by 45 Litres per minute. This will be done on room air. Note oxygen saturations will be measured via a TOSCA.
Sponsors
Richard Beasley
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of chronic obstructive pulmonary disease with baseline oxygen saturations of 85-92%. A raise in transcutaneous carbon dioxide of greater than or equal to 4mmHg on eligibility testing (50% oxygen administration via a mask until transcutaneous carbon dioxide increases by greater than or equal to 4mmHg or for 20 minutes).
Exclusion criteria
An intercurrent chest infection FEV1>50% predicted FEV1:FVC >0.7 Baseline transcutaneous carbon dioxide of greater than 60mmHg Diagnosis of a disease causing restriction to chest wall expansion (neuromuscular disease or chest wall dysfunction) Obesity (body mass index greater than or equal to 40) Inability to tolerate the Airvo device at 25 and 45 Litres per minute Any other condition which, at the investigator's discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.
Outcome results
None listed