None listed
Conditions
Brief summary
This study is a feasibility study evaluating user comfort and tolerability of humidified flow therapy in people with Chronic Obstructive Pulmonary Disease (COPD) and/or bronchiectasis with sputum burden. We think that people with COPD and/or bronchiectasis will find humidified high flow therapy comfortable and tolerable.
Interventions
This feasibility study uses a staged, iterative cohort design, where participants are enrolled in sequential cohorts (up to 10 participants per cohort). Following completion of each cohort, study data are reviewed by the research team. Based on these findings, modifications to the investigational device settings may be implemented prior to enrolment of the next cohort.
As a result, the exact configuration of the intervention may differ between cohorts, but all interventions remain based on humi
This feasibility study uses a staged, iterative cohort design, where participants are enrolled in sequential cohorts (up to 10 participants per cohort). Following completion of each cohort, study data are reviewed by the research team. Based on these findings, modifications to the investigational device settings may be implemented prior to enrolment of the next cohort. As a result, the exact configuration of the intervention may differ between cohorts, but all interventions remain based on humidified high-flow therapy delivered via the modified Airvo 3 device. Participants will receive humidified high-flow therapy delivered via a modified Airvo 3 investigational device that provides heated, humidified air with variable flow. Therapy delivered via a patient interface while seated - Administered by physiotherapists in an outpatient setting - Participants breathe normally through the interface - Therapy can be paused or stopped at any time at participant request Continuous monitoring of: - Peripheral oxygen saturation (SpO2) - Heart rate (HR) - Respiratory rate (RR) Familiarisation period: - Prior to the intervention, participants complete a short familiarisation period to enable participants to use the interface without the therapy and to feel the therapy on their hand without the interface. Washout / recovery period: Following the intervention, participants undergo a recovery period: - Up to 20 minutes, or until physiological parameters return to within 10% of baseline values - Includes quiet rest, written ratings, and a semi-structured interview. Randomisation: - Participants are randomised to determine the order in which intervention conditions are delivered within the session. Cohort: - Each participant will only be exposed to 2 interventions (an intervention and a comparator) within their cohort. - The intervention and comparator are determined prior to the cohort being initiated and are based on the previous cohorts' results. Analysis: - Results from participants with Chronic Obstructive Pulmonary Disease (COPD) and/or bronchiectasis with sputum burden will be analysed together.
Sponsors
Fisher & Paykel Healthcare
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults aged greater than or equal to 18 years. • Confirmed diagnosis of COPD and/or bronchiectasis. • Clinically stable (no exacerbation or hospitalisation in the past 6 weeks). • Able to provide informed consent. • Self or clinically reported sputum burden. • Able to understand and speak conversational English.
Exclusion criteria
• Age less than 18 years. • Presence of an acute condition (e.g. pneumonia, acute congestive heart failure, pulmonary embolus) • Active haemoptysis • Recent pneumothorax within the past 8 weeks • Current known respiratory infection or acute exacerbation • Recent thoracic surgery or hospitalisation within the past 6 weeks • Recent facial, oral, or skull surgery or trauma • Haemodynamic instability • Bullous emphysema • Elevated intracranial pressure • Known tympanic membrane rupture or other middle ear pathology • Active epistaxis (bleeding nose) • Nausea or vomiting within the last 48 hours • Known issues with swallowing or swallow reflex • Severe cognitive impairment or inability to follow instructions • Pregnancy or breastfeeding • Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the study or the study results.
Outcome results
None listed