None listed
Conditions
Brief summary
This study will compare the effect of Nasal High Flow therapy and Non-invasive ventilation on the blood levels of carbon dioxide (PaCO2) in participants with chronic respiratory failure associated 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 12000 hospital admissions in New Zealand every year. NHF therapy has a potential role in lowering carbon dioxide levels in COPD patients and we therefore wish to study the effects further and compare it to the gold standard of NIV. 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 the 2 interventions for 60 minutes at a time and a ‘washout’ period of 15 minutes after each. There will be a 30 minute 'wash in' period whereby supplemental oxygen will be given, if required, to maintain oxygen saturations of 88-92%. This oxygen flow will be used at the start of intervention 1 and continuously titrated through either the NHF or NIV to maintain oxygen saturations of 88-92%. The participant will be asked to complete a tolerability questionnaire following each 60 minute intervention. and will be asked about their breathlessness, on the BORG dyspnoea score, before and after each intervention.. The primary aim of the study is to identify whether the NHF device has an equivalent impact on PaCO2 levels, compared to NIV in participants. Secondary outcomes include how well participants tolerate the 2 devices and other physical parameters such as respiratory rate, oxygen saturations,and heart rate.
Interventions
Nasal high flow (NHF) therapy, via the myAIRVO 2 device at 45 Litres per minute, 37 degrees for 60 minutes at the Medical Research Institute of New Zealand Respiratory Physiology Lab. This involves breathing heated and humidified room air (and oxygen if required) through the nasal interface (nasal prongs which sit inside both nostrils). Oxygen, if required, will be administered through the device and titrated by the investigator to maintain saturations 88-92%.
There will be a 30 minute wash-i
Nasal high flow (NHF) therapy, via the myAIRVO 2 device at 45 Litres per minute, 37 degrees for 60 minutes at the Medical Research Institute of New Zealand Respiratory Physiology Lab. This involves breathing heated and humidified room air (and oxygen if required) through the nasal interface (nasal prongs which sit inside both nostrils). Oxygen, if required, will be administered through the device and titrated by the investigator to maintain saturations 88-92%. There will be a 30 minute wash-in period before starting Intervention 1 where oxygen will be administered, if required, and titrated by the investigator to maintain saturations of 88-92%. The oxygen flow at the end of this wash-in will be used at the start of Intervention 1. There will be a 15 minute washout period between interventions and recordings will continue during this time. The washout will be extended until the PtCO2 returns to within 4mmHg of t=0 recording of intervention 1.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, 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. PcapCO2 >45mmHg on Capillary blood gas, at point of randomisation 3. Age greater than or equal to 40 years old.
Exclusion criteria
1. Smoking pack year history <10 years 2. FEV1/FVC greater than or equal to 70% 3. Body mass index >35 4. Hypercapnea believed to be primarily due to Obesity Hypoventilation syndrome and/or Obstructive Sleep Apnoea 5. Any condition which makes NIV contra-indicated as per BTS guidelines. 6. Requiring greater than or equal to 4 L/min through standard nasal cannulae during the wash-in period to maintain oxygen saturations 88-92%. 7. COPD not deemed to be ‘stable’: a. Current exacerbation requiring acute treatment with a short course of antibiotics/oral steroids within the last 2 weeks. b. Hospital admission for an acute exacerbation of COPD in the last 6 weeks. 8. Nasal conditions such as deviated septum, chronic rhinitis, current cold/flu which, in the evaluation by the investigator, could impair nasal breathing. 9. 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