Brief Title
Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure
Official Title
Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure
Brief Summary
The aim of this study is to assess the benefit of a portable ventilator generating positive
end-expiratory pressure on exercise tolerance in patients with Excessive dynamic airway
collapse (EDAC) and tracheobronchomalacia (TBM).
Detailed Description
Excessive dynamic airway collapse (EDAC) and tracheobronchomalacia (TBM) occur due to
abnormal weakening of the walls of the central airways leading to central airway collapse on
expiration. This collapse is responsible for breathlessness, cough or syncope. In adults,
this weakening can be idiopathic (Mounier-Khun syndrome), secondary to respiratory diseases
such as chronic obstructive pulmonary disease (COPD), secondary to systemic diseases such as
relapsing polychondritis (RP) or secondary to invasive ventilation or trauma. The incidence
of EDAC and TBM varies from 12% in all patients undergoing bronchoscopy to 44% in patients
with chronic bronchitis undergoing bronchoscopy. Gold standard for the diagnosis of EDAC and
TBM is bronchoscopy which identifies and quantifies the narrowing of the airway. Non-invasive
technique such as inspiratory and expiratory chest computed-tomography (CT) can also be used
to diagnose EDAC / TBM.
Currently, in addition to management of the underlying disease, treatment options for EDAC /
TBM are limited. Surgical tracheoplasty can be offered but can be associated with severe
post-operative complications. Airway stenting can also be offered but, even if this treatment
improved quality of life, it fails to improve exercise capacity. Airway stenting is also
associated with infectious complications as well as stent migrations. Other endoscopic
treatment such as Yttrium Aluminium Perovskite laser can be offered with good results but
have not yet been validated in a randomised trial. Nocturnal non-invasive ventilation (NIV)
can also be used, especially in patients with associated obstructive sleep apnoeas but again
there is not randomised clinical trial evidence that validates this approach in adults.
Expiratory Positive Airway Pressure (EPAP) provides a pneumatic stenting that prevents the
expiratory collapse of the airway. But, by giving the NIV during the night, patients are left
without any support during the day whilst their respiratory demand is higher and when they
are more symptomatic. Currently, NIV is only given at night or at rest because current
non-invasive ventilators are not suitable for ambulatory use as they are heavy. Recently, a
new portable ventilator with built-in battery has been issued (Z1®, Breas®). This ventilator
is light (500g) portable and has a working duration of 8 hours. Therefore, it can be easily
carried and used while walking. By providing a nasal pillow interface (Nasal swift®, Resmed®)
to patients, it will allow them to walk safely with the device on.
Study Type
Interventional
Primary Outcome
Does daytime activity by an accelerometer change from baseline to 4 weeks
Secondary Outcome
Distance in 6-MWT on Continous Positive Airway Pressure (CPAP) at 4 weeks follow-up
Condition
Excessive Dynamic Airway Collapse
Intervention
Experimental: Treatment
Study Arms / Comparison Groups
Run In Phase
Description: Eligible patients will have 6-Minute Walk Test (6-MWT) on self ventilation and on CPAP
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
21
Start Date
September 2016
Completion Date
June 14, 2017
Primary Completion Date
June 14, 2017
Eligibility Criteria
Inclusion Criteria:
- Patient with diagnosed EDAC or TBM on inspiratory/expiratory CT or bronchoscopy
- Patient with exertional dyspnea
Exclusion Criteria:
- Pregnancy
- Significant physical or psychiatric comorbidity that would prevent compliance with
trial protocol
- Inability to perform 6-MWT
- Current intra-tracheal stent
- Previous surgery for EDAC or TBM
- Uncontrolled underlying disease:
- Initiation of home mechanical ventilation in last 3 months
- Uncontrolled joint pain
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Nick Hart, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT02763631
Organization ID
16/LO/0028
Responsible Party
Sponsor
Study Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
B&D Electromedical
Study Sponsor
Nick Hart, Study Chair, Guys and St Thomas' NHS Foundation Trust
Verification Date
May 2018