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

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ClinicalTrials.gov Identifier: NCT02763631
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : May 29, 2018
Sponsor:
Collaborator:
B&D Electromedical
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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).

Condition or disease Intervention/treatment Phase
Excessive Dynamic Airway Collapse Tracheobronchomalacia Other: Experimental: Treatment Other: Experimental: Run In Phase Other: Sham Comparator: Stand Care Arm Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure
Study Start Date : September 2016
Actual Primary Completion Date : June 14, 2017
Actual Study Completion Date : June 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Run In Phase
Eligible patients will have 6-Minute Walk Test (6-MWT) on self ventilation and on CPAP
Other: Experimental: Run In Phase
Participants will undergo a run-in phase during which they will undergo baseline assessments. If they tolerate the portable CPAP and if their 6-MWT improves by more than 30m when performed on CPAP, they will be randomised into the trial.

Experimental: Treatment

Those patients who improve their 6-MWT by more than 30 meters will then be randomised to either:

Treatment arm - Patients will be setup onto portable CPAP during the day

Other: Experimental: Treatment
Participants will be established on portable CPAP during the day with nasal pillows as an interface and requested to use it at least 8 hours/day.

Sham Comparator: Standard Care Arm

Those patients who improve their 6-MWT by more than 30 meters will then be randomised to either:

Control Arm - Standard care arm.

Other: Sham Comparator: Stand Care Arm
No change will be made to participants care




Primary Outcome Measures :
  1. Does daytime activity by an accelerometer change from baseline to 4 weeks [ Time Frame: 4 weeks ]
    Daytime activity assessed by an accelerometer. Participants will be assessed at baseline and at 4 weeks in the control arm and in the treatment arm with participants on portable CPAP to see if there is any change between the time frames and between the groups on daytime activity measured by accelerometers that all participants randomised into the trial will wear from baseline to follow up at 4 weeks.


Secondary Outcome Measures :
  1. Distance in 6-MWT on Continous Positive Airway Pressure (CPAP) at 4 weeks follow-up [ Time Frame: 4 weeks ]
    Is there a change in exercise capacity measured by 6-MWT for all patients in the study from baseline to 4 weeks. All walk tests will be performed on portable Continuous Positive Airway Pressure (CPAP)

  2. Change in respiratory-related quality of life - Severe Respiratory Insufficiency (SRI) [ Time Frame: 4 weeks ]
    Is there a change in quality of life from baseline to 4 weeks measured by Severe Respiratory Insufficiency Questionnaire

  3. Change in respiratory-related quality of life - St George's Respiratory Questionnaire (SGRQ) [ Time Frame: 4 weeks ]
    Is there a change in quality of life from baseline to 4 weeks measured by St George's Respiratory Questionnaire.

  4. Change in neural respiratory drive with parasternal electromyography [ Time Frame: 4 weeks ]
    Is there a change in neural respiratory drive measured by parasternal electromyography both at rest and whilst using portable CPAP at baseline and at 4 weeks

  5. Change of lung homogeneity assessed by electrical impedance tomography while on CPAP [ Time Frame: 4 weeks ]
    Is there a change in lung homogeneity in participants from baseline to 4 weeks. Measured by electrical impedence tomography whilst all participants are using portable CPAP

  6. Change in cross-sectional area quadriceps rectus femoris ultra-sound [ Time Frame: 4 weeks ]
    Is there a change in the area of the quadriceps rectus femoris in participants from baseline to 4 weeks. Measured using ultrasound which will be performed on all participants



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763631


Locations
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United Kingdom
Guys and St Thomas NHS Foundation
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
B&D Electromedical
Investigators
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Study Chair: Nick Hart Guys and St Thomas' NHS Foundation Trust
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02763631    
Other Study ID Numbers: 16/LO/0028
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tracheobronchomalacia
Shock
Pathologic Processes
Cartilage Diseases
Musculoskeletal Diseases
Bronchial Diseases
Respiratory Tract Diseases
Tracheal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases