Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure

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