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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-06-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Portable Continuous Positive Airways Pressure (CPAP) in Excessive Central Airway Collapse (ECAC) Study

NCT06072872

Excessive Central Airways Collapse Respiratory Disease Tracheobronchomalacia +1 more

UNKNOWN NA

Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

NCT01082666

Critically Ill

COMPLETED PHASE4

Pulmonary Expansion Device in Tracheostomized Patients Therapies in Tracheostomized Patients

NCT06075381

Postoperative Complications Rehabilitation Postoperative Care

NOT_YET_RECRUITING PHASE2

High-Flow Tracheal Therapy on Tracheobronchial Secretions in Tracheostomized Patients

NCT06897319

Tracheostomized Patients

NOT_YET_RECRUITING NA

Endobronchial Silicone Valve for Patients With Emphysema

NCT07097896

Emphysema

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Excessive Dynamic Airway Collapse Tracheobronchomalacia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Run In Phase

Eligible patients will have 6-Minute Walk Test (6-MWT) on self ventilation and on CPAP

Group Type EXPERIMENTAL

Experimental: Run In Phase

Intervention Type OTHER

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.

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

Group Type EXPERIMENTAL

Experimental: Treatment

Intervention Type OTHER

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.

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.

Group Type SHAM_COMPARATOR

Sham Comparator: Stand Care Arm

Intervention Type OTHER

No change will be made to participants care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Sham Comparator: Stand Care Arm

No change will be made to participants care

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No