Excessive Central Airways Collapse, Excessive Dynamic Airway Collapse, Respiratory Disease, Tracheobronchomalacia
Conditions
Brief summary
This study will investigate the role of a portable Continues Positive Airway Pressure device (pCPAP) in management of patients with symptomatic Excessive Central Airway Collapse (ECAC). ECAC is characterised by complete or partial collapse of central airways on exhalation. In some cases, this can cause persistent breathlessness and severely limited exercise capacity. Current treatment options for ECAC are very limited. Standard assistive breathing devices such as CPAP machines are sometimes used to relieve symptoms at night or at rest. This does not address breathlessness during activity which drives accumulation of disability over time. The main aims of this project are to assess the effect of a portable CPAP (pCPAP) device on exercise capacity and symptoms and evaluate the feasibility of wearing pCPAP at home during routine activities. Lightweight battery-powered portable CPAP devices have been recently developed to facilitate travel to remote areas by people with Obstructive Sleep Apnoea (OSA). Patients with ECAC can wear them during physical activity to prevent airway collapse but their potential benefits have not been evaluated in clinical trials. For this study, the investigators will recruit 20 patients with ECAC who will attend for two study visits 4-6 weeks apart in a single centre (The Royal Papworth Hospital). The primary outcome measure will be a shuttle walk test performed repeatedly with and without pCPAP in a randomised order. Secondary outcomes will include assessment of activity level, breathlessness, quality of life ,pCPAP usage and its acceptability. The study will evaluate a pragmatic way of CPAP titration and application. Previously acquired diagnostic baseline computed tomography (CT) scans will be analysed with a novel Functional Respiratory Imaging (FRI) tool. This software tool will enable retrospective reflections on the changes occurring within the lungs for patients with ECAC. This may help identify predictive features of potential pCPAP responders and inform future use.
Interventions
DEVICEUse of portable CPAP
Patients use portable CPAP during exercise
Sponsors
Papworth Hospital NHS Foundation Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective interventional, with first period without use of study device, followed with second period using study device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of ECAC based on \>50% reduction of the antero-posterior diameter of large airways demonstrated on dynamic CT thorax or bronchoscopy. Only patients with tracheal and/or bilateral large bronchi (main to lobar) involvement will be included. 2. Symptoms of dyspnoea felt to be predominantly caused by ECAC (where ECAC is the only respiratory pathology or dyspnoea is clearly out of proportion to a co-morbid respiratory condition) 3. Medical Research Council (MRC) breathlessness scale of 3 (I stop for breath after walking about 100 yards or after a few minutes on level ground) or more. 4. Age over 18 years 5. Able to give informed consent -
Exclusion criteria
* Patients with dynamic collapse of only segmental airways * Comorbidity which is likely to be an additional limiting factor in exercise tolerance * Contraindication to CPAP * Contraindication to incremental shuttle walk testing (ISWT), including; myocardial infarction within the last 3-5 days, unstable angina, uncontrolled arrhythmia, severe symptomatic cardiac or valvular disease, acute pulmonary embolus, uncontrolled asthma, syncope, mental impairment resulting in inability to perform test. * Resting oxygen saturations \<90% on air or need for ambulatory oxygen therapy * Immobility that would make ISWT unfeasible * Severe emphysema * Acute infectious disease * Acute respiratory illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance achieved in incremental shuttle walk test with and without portable CPAP | After using portable CPAP for four weeks | Distance achieved in incremental shuttle walk test with and without portable CPAP after using portable CPAP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of dyspnoea pre and post shuttle walk test | During shuttle walk test performed after four weeks of using portable CPAP | dyspnoea will be measured using the Borg scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score | 4 weeks | Respiratory-specific quality of life after use of portable CPAP using St George's Respiratory Questionnaire (scores range from 0 to 100, with higher scores indicating more limitations) and Severe Respiratory Insufficiency (SRI) questionnaire (score of 0 to 100 represents the worst to best health-related quality of life) |
| Feasibility of CPAP self-titration | 4 weeks | Feasibility and efficacy of CPAP self-titration using Likert scale (range 1-5, higher scores indicate better outcomes), change in CPAP pressure levels and distance walked whilst using portable CPAP |
| Activity levels with and without portable CPAP | 30 day | Activity levels based on pedometer readings |
| Correlation between severity of ECAC disease and response to portable CPAP | 4 weeks | Correlation between severity of ECAC disease (as determined by FRI measurements in CT scans) and response to portable CPAP |
| participant perception of using portable CPAP | 4 weeks | Participant acceptance of using CPAP and its perceived impact on activity level: assessed using a Likert scale ((range 1-5, higher scores indicate better outcomes) |
| Average daily usage of CPAP | 30 days | Absolute hours of daily usage |
Countries
United Kingdom
Contacts
Primary ContactDariusz Wozniak, MD, PhD
Backup ContactVictoria EA Stoneman, BSc, PhD
Outcome results
None listed