Clinical trial NCT06072872: Portable Continuous Positive Airways Pressure (CPAP) in Excessive Central Airway Collapse (ECAC) Study
Official title: Portable Continuous Positive Airways Pressure (CPAP) in Excessive Central Airway Collapse (ECAC) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Excessive Central Airways Collapse
Respiratory Disease
Tracheobronchomalacia
Excessive Dynamic Airway Collapse
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2023-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective interventional, with first period without use of study device, followed with second period using study device
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Distance achieved in incremental shuttle walk test with and without portable CPAP
timeFrame: After using portable CPAP for four weeks
Secondary outcomes:
measure: Degree of dyspnoea pre and post shuttle walk test
timeFrame: During shuttle walk test performed after four weeks of using portable CPAP
Other outcomes:
measure: Activity levels with and without portable CPAP
timeFrame: 30 day
measure: Average daily usage of CPAP
timeFrame: 30 days
measure: Quality of life score
timeFrame: 4 weeks
measure: Feasibility of CPAP self-titration
timeFrame: 4 weeks
measure: participant perception of using portable CPAP
timeFrame: 4 weeks
measure: Correlation between severity of ECAC disease and response to portable CPAP
timeFrame: 4 weeks
Locations:
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
state: Cambridgeshire
Study officials:
affiliation: Royal Papworth Hospital NHS Foundation Trust
name: Dariusz Wozniak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: