A Randomised Feasibility Study of CPAP in Large Airway Collapse
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient acceptability
研究概览
简要总结
Large airway collapse (LAC) is an increasingly recognised condition characterised by either bowing of the posterior membrane/trachealis muscle into the trachea or main bronchi (also known as excessive dynamic airway collapse, EDAC) or weakening of the tracheal cartilage (also known as tracheobronchomalacia, TBM).(1-3) LAC often co-exists with other chronic airway conditions, such as asthma or chronic obstructive pulmonary disease (COPD) and is frequently misdiagnosed or overlooked as symptoms, such as shortness of breath, cough and wheeze overlap with other respiratory disease.(1) There is no standardised treatment pathway for patients diagnosed with LAC and current treatment options are limited to physiotherapy and/or hypertonic saline.(3) Exacerbations of LAC, defined as an acute worsening of respiratory symptoms, typically reduce health-related quality of life and increase healthcare utilisation.(4) Small studies and case series have suggested continuous positive airway pressure (CPAP) as a potential treatment for LAC to reduce exacerbations and improve quality of life.(5,6) It is hypothesised CPAP may work as a pneumatic splint helping to prevent dynamic collapse of the large airways. This may increase lung volumes due to increase in flow at functional residual capacity (FRC) and support higher elastic recoil and increased expiratory flow. Additionally, splinting of the large airways may cause stiffening of the large airways, resulting in less resistance and turbulence during expiration and may support sputum expectoration.(3) There is a need for high quality randomised controlled trial (RCT) evidence to inform clinical recommendations in the United Kingdom (UK), as well as globally. Prior to this there is a need for further work exploring the feasibility of performing a large RCT and understanding the acceptability of CPAP as a future treatment for LAC.
Aim To conduct a randomised feasibility study that will provide data to confirm if a larger randomised trial of CPAP in patients diagnosed with LAC is viable
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years) at visit 1
- •Able to provide informed consent
- •Prior confirmation of LAC (diagnosed either radiographically or with bronchoscopy)
- •Respiratory co-morbidities optimised
- •≥1 course of antibiotics and/or prednisolone for an exacerbation of chronic airway disease in the preceding 12 months before visit 1.
排除标准
- •Contraindication to CPAP as per British Thoracic Society (BTS) guidelines
- •Already using domiciliary CPAP (including privately purchased)
- •Known obstructive sleep apnoea syndrome (OSAS) eligible for CPAP
- •Suspected OSAS that is awaiting further investigation
- •Pregnant or planning a pregnancy in the next 12 months
研究组 & 干预措施
Standard of Care
Standard of care for LACS. Which includes physio and good asthma management
Intervention (CPAP)
Nocturnal CPAP
干预措施: CPAP (Device)
结局指标
主要结局
Patient acceptability
时间窗: From Enrolment until 1 year
1. All participants will be asked to complete a questionnaire, which will give us information about their diagnosis pathway, current health and wellbeing related to LAC and other information about treatment options. 2. Participation in an audio-recorded semi-structured interview will be offered to participants in both arms, to facilitate the collection of more detailed insights surrounding LAC as a condition, diagnosis pathway, treatments (including CPAP). Interview topic guides will be co-produced with the patient and public involvement (PPI) lead. Interviews will be scheduled at the patient's convenience on or after visit 3 (6 months) and will be conducted face-to-face, virtually or by telephone. We will aim to interview up to 10 participants in each arm, or until data saturation is reached. Interviews will be recorded using industry standard recording device/Dictaphone, transcribed, and data analysed under the guidance of the qualitative lead.
Recruitment and Retention
时间窗: At 18 months post enrolment
The site will be asked to keep a screening log of all patients identified, approached and given an information leaflet. The number of participants enrolled (defined as a participant providing written informed consent) and the proportion randomised will be reported. Reasons for screen failure and withdrawal will be collected and summarised in the CRF. Recruitment and retention will be periodically assessed in line with agreed targets with the funder.
次要结局
- Health Related Quality of Life Assessment(At enrolment and 18 months)
- Healthcare Resource Utilisation(At 18 months post enrolment)