Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure (EPOC)
Primary Purpose
Excessive Dynamic Airway Collapse, Tracheobronchomalacia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Experimental: Treatment
Experimental: Run In Phase
Sham Comparator: Stand Care Arm
Sponsored by
About this trial
This is an interventional treatment trial for Excessive Dynamic Airway Collapse
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
Sites / Locations
- Guys and St Thomas NHS Foundation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Run In Phase
Treatment
Standard Care Arm
Arm Description
Eligible patients will have 6-Minute Walk Test (6-MWT) on self ventilation and on CPAP
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
Those patients who improve their 6-MWT by more than 30 meters will then be randomised to either: Control Arm - Standard care arm.
Outcomes
Primary Outcome Measures
Does daytime activity by an accelerometer change from baseline to 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
Distance in 6-MWT on Continous Positive Airway Pressure (CPAP) at 4 weeks follow-up
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)
Change in respiratory-related quality of life - Severe Respiratory Insufficiency (SRI)
Is there a change in quality of life from baseline to 4 weeks measured by Severe Respiratory Insufficiency Questionnaire
Change in respiratory-related quality of life - St George's Respiratory Questionnaire (SGRQ)
Is there a change in quality of life from baseline to 4 weeks measured by St George's Respiratory Questionnaire.
Change in neural respiratory drive with parasternal electromyography
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
Change of lung homogeneity assessed by electrical impedance tomography while on CPAP
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
Change in cross-sectional area quadriceps rectus femoris ultra-sound
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
Full Information
NCT ID
NCT02763631
First Posted
May 4, 2016
Last Updated
May 24, 2018
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
B&D Electromedical
1. Study Identification
Unique Protocol Identification Number
NCT02763631
Brief Title
Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure
Acronym
EPOC
Official Title
Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 14, 2017 (Actual)
Study Completion Date
June 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
B&D Electromedical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excessive Dynamic Airway Collapse, Tracheobronchomalacia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Run In Phase
Arm Type
Experimental
Arm Description
Eligible patients will have 6-Minute Walk Test (6-MWT) on self ventilation and on CPAP
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Care Arm
Arm Type
Sham Comparator
Arm Description
Those patients who improve their 6-MWT by more than 30 meters will then be randomised to either:
Control Arm - Standard care arm.
Intervention Type
Other
Intervention Name(s)
Experimental: Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental: Run In Phase
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Comparator: Stand Care Arm
Intervention Description
No change will be made to participants care
Primary Outcome Measure Information:
Title
Does daytime activity by an accelerometer change from baseline to 4 weeks
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Distance in 6-MWT on Continous Positive Airway Pressure (CPAP) at 4 weeks follow-up
Description
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)
Time Frame
4 weeks
Title
Change in respiratory-related quality of life - Severe Respiratory Insufficiency (SRI)
Description
Is there a change in quality of life from baseline to 4 weeks measured by Severe Respiratory Insufficiency Questionnaire
Time Frame
4 weeks
Title
Change in respiratory-related quality of life - St George's Respiratory Questionnaire (SGRQ)
Description
Is there a change in quality of life from baseline to 4 weeks measured by St George's Respiratory Questionnaire.
Time Frame
4 weeks
Title
Change in neural respiratory drive with parasternal electromyography
Description
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
Time Frame
4 weeks
Title
Change of lung homogeneity assessed by electrical impedance tomography while on CPAP
Description
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
Time Frame
4 weeks
Title
Change in cross-sectional area quadriceps rectus femoris ultra-sound
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Hart
Organizational Affiliation
Guys and St Thomas' NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Guys and St Thomas NHS Foundation
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure
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