Every breath a patient with large airway collapse takes can cause their airway to partially or fully close, trapping air and making it hard to exhale. This study tests whether a CPAP machine—a device that gently pushes air into the lungs overnight—can keep those airways open and reduce dangerous flare-ups. Around 27% of people with chronic lung conditions like COPD or asthma also have large airway collapse, yet treatment options are limited to physiotherapy and saline nebulisers. Patients suffer repeated exacerbations that send them to hospital and erode their quality of life. Small studies suggest CPAP might help, but no robust trial has tested it. This feasibility study will randomise 60 patients in Liverpool to either standard care or nocturnal CPAP. Over a year, the team will track recruitment, retention, quality of life, and exacerbation rates, alongside patient interviews to understand whether CPAP is acceptable. If the data meet pre-set criteria, the researchers will apply for funding to run a full randomised trial. Success could transform a neglected condition from a source of repeated hospital visits into something manageable at home, reducing pressure on the NHS and giving patients back better sleep and easier breathing.
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Scientific Abstract Research Question Is nocturnal Continuous Positive Airway Pressure (CPAP) an acceptable and feasible treatment for patients diagnosed with Large airways collapse? A randomised feasibility study in Liverpool. Background LAC is an increasingly well recognised problem and prevalent co-morbidity in patients with chronic respiratory conditions such as Chronic Obstructive Pulmonary Disease and Asthma. Approximately 27% of patients with chronic respiratory conditions have LAC, diagnosed by inspiratory/expiratory CT-scans or bronchoscopy. Despite this the treatment options are limited to physiotherapy plus/minus hypertonic saline nebulizers. Patients often suffer exacerbations as a result of LAC, leading to decreased quality life and increase use of the hospital system. Small studies and case series suggest CPAP maybe an effect treatment in LAC, reducing exacerbation and improving quality of life. Hypothesis CPAP is an acceptable and feasible treatment that shows a trend towards reducing the number of exacerbations and improving quality life in patients with known LAC without OSAS. Aim To conduct a randomised feasibility study that will provide data to confirm if a larger randomise trial of CPAP in patients diagnosed with LAC is viable Objectives: 1. Obtain recruitment and retention data from both an intervention and control arm to inform a full RCT 2. Determine changes in health-related quality of life and exacerbation rate 3. Understand the acceptability and patient perspective of using CPAP as an intervention for LAC 4. Develop a health economic analysis protocol for a full cost-effective analysis ready for a future RCT Methods We will perform a Liverpool based randomised feasibility study of the use of nocturnal Continuous Positive Airway Pressure (CPAP) in patients with known Large Airway Collapse. We will randomise 60 patients into a control arm of standard of care (Respiratory Physiotherapy plus/minus saline nebuliser) or intervention arm of nocturnal CPAP. Patients will be reviewed in person at 3 time points throughout the year and a subset will be invited to take part in qualitative interviews. Timelines Month 1-7: Ethics approval, MHRA approval, sponsorship, staff and PPI recruitment and site set up Month 8-30: Recruitment, randomisation (workstream one). Qualitative Interviews (workstream 2) ,PPI workshops. Month 30-32: Data analysis, including workstream 3's HEAP . PPI results sharing meeting. Month 30-36: Apply for HTA if criteria met. Publish the results of the feasibility in peer review journal. Disseminate the results to participants. Anticipated impact and dissemination Using a pre-set criteria data gained for this study will inform if a full RCT is indicated and if so provide data for power calculations, timeframes and patient opinion on the primary outcome. A health economic protocol for a full RCT will also be development. We anticipate gaining new a rich data on patient perspectives of LAC and CPAP which will feed into a RCT. The results of the study will be published in peer reviewed journals, and will be submitted to two respiratory conferences, including one focusing on Allied Health Professionals. A video to feedback to participants will be made in collaboration with the PPI team.
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