None listed
Conditions
Brief summary
Chronic obstructive pulmonary disease (COPD) is an incurable illness characterised by airflow limitation, persisting respiratory symptoms and progressive respiratory failure.. Nasal high flow (NHF) therapy is a new respiratory support system. NHF washes out carbon dioxide from airway dead space in the lungs to improve ventilation and also generates a low-level positive airway pressure that reduces airway resistance to reduce the work of breathing. This mixed methods research project including feasibility and qualitative studies will determine if domiciliary NHF is a feasible and acceptable intervention for severe breathlessness in COPD. Secondly these results will inform a world-first, multi-site Phase 3 RCT, to determine if long-term, domiciliary NHF is an effective and cost-effective, new intervention for severe breathlessness in people with COPD who do not qualify for domiciliary continuous oxygen therapy.
Interventions
Nasal High Flow (NHF) therapy is a non-invasive respiratory support device that delivers heated (30 - 37oC), humidified, high flow (between 2 to 60L/min) air through a specialised nasal cannula, with airflow generated from a flow generator system (AirvoTM 2 System). High-flow air mix only will be used, no oxygen will be administered.
On this single arm study, all participants will receive NHF therapy intervention.
All study participants will have assessments performed at a single timepoint at
Nasal High Flow (NHF) therapy is a non-invasive respiratory support device that delivers heated (30 - 37oC), humidified, high flow (between 2 to 60L/min) air through a specialised nasal cannula, with airflow generated from a flow generator system (AirvoTM 2 System). High-flow air mix only will be used, no oxygen will be administered. On this single arm study, all participants will receive NHF therapy intervention. All study participants will have assessments performed at a single timepoint at baseline (between Day -2 to Day 1). Following this, a respiratory scientist or a nurse trained in setting up NHF will assist with the initial NHF set-up for each participant. This will be conducted in the RMH respiratory lab for out-patients or on the respiratory or palliative care wards for inpatients. There are no current published guidelines on NHF titration. No oxygen will be entrained in the system as patients will not have severe resting hypoxaemia. The set up of NHF is individualised, however a suggested standard approach will follow the guidelines below: 0 minutes - 10 L/min - 31 degrees C 10 minutes - 15 L/min - 34 degrees C 20 minutes - 20 L/min - 37 degrees C 30 minutes - 25 L/min - 37 degrees C 40 minutes - 30 L/min - 37 degrees C with optional increases on 5 L/min every 10 minutes up to 60 L/min Participants will be educated on how to use NHF at home and advised to wear it for a minimum of 7 hours at night, with additional use in the day as desired. Once set up, participants will commence the intervention on Day 1, and this will continue for 7 consecutive days until day 7. Post-intervention measures will be taken following completion of study (Day 8). Participants will be asked to participate in a semi-structured interview to explore their experiences and acceptance of NHF therapy. Compliance will be recorded in a patient diary.
Sponsors
Melbourne Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Underlying diagnosis of severe COPD – evidence on pulmonary function tests performed within the last 24 months of Forced Expiratory Ratio (FER) <70% and Forced Expiratory Volume 1sec (FEV1) <50% • Physician confirmed optimisation of treatment of underlying disease • Breathlessness scale: Level 3 or above on the modified Medical Research Council (mMRC) dyspnoea scale (Bausewein, et al., 2007) • Not currently using domiciliary long-term oxygen therapy at rest via a concentrator for 16 hours/day (oxygen saturations > 92% at rest). However patients who only use exertional oxygen therapy from portable oxygen cylinders for exertion induced hypoxaemia are eligible • Able and willing to provide written informed consent • Capable of completing assessments and complying with the study procedures
Exclusion criteria
• Acute exacerbations of COPD in the past four weeks (i.e. unstable disease) • Enrolment in other clinical trials that may impact study outcomes (e.g. trials on breathlessness, opioids, benzodiazepines) • Commenced on opioids or benzodiazepines within the last 14 days or requiring commencement of these medications while on study. Patients who were commenced on slow or immediate release opioids or benzodiazepines >14 days prior to study enrolment may continue to use these while on study. • Previous adverse reaction to NHF • Clinician predicted survival less than seven days • Pregnant or breastfeeding • Chronic alcoholism or drug abuse • Contraindications to NHF use: o Requiring Non-Invasive or Invasive ventilation o Altered level of consciousness (GCS 10 or below) o Suspected or known base of skull fracture o Inability to maintain own airway or unable to tolerate nasal prongs o Recent surgery (in last 30 days) to the nose or upper airway - including pituitary surgery via a trans sphenoidal approach o Significant facial fractures or trauma in last 30 days o Nasal obstruction or nasal packing
Outcome results
None listed