Tracheobronchomalacia: Treatment Outcomes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00550602

Enrollment

150

Registered

2007-10-30

Start date

2002-01-31

Completion date

2010-03-31

Last updated

2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheobronchomalacia, Tracheomalacia

Keywords

Tracheomalacia, Tracheobronchomalacia, Airway Stabilization, Bronchoscopy, Stent Placement, Tracheobronchoplasty, COPD

Brief summary

The purpose of this study is to evaluate respiratory symptoms and their impact in the quality of life and after treatment of the respiratory condition (tracheobronchomalacia - TBM).

Detailed description

TBM is an abnormal collapse of the tracheal and bronchial walls. It is characterized by flaccidity of the supporting tracheal and bronchial structures and a significant reduction of airway diameter on expiration seen in the trachea and/or in the mainstem bronchi. Currently there is no available data on the efficacy of central airway stabilization for treating TBM. Our study would provide this important information and would establish the effect of central airway stabilization on symptoms, functional status, quality of life, lung function and exercise capacity in patients with symptomatic and severe TBM.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Suspicion of symptomatic tracheal and/or bronchial collapse during bronchoscopy or Dynamic Computed Tomographic study. * Chronic Obstructive Pulmonary Disease (regardless of severity) and suspicion of tracheal and/or bronchial collapse

Exclusion criteria

* inability to follow commands * Focal extrinsic compression of the trachea/bronchi by mass or other

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia.	At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty

Secondary

Measure	Time frame
To evaluate the effect of central airway stabilization on lung function, exercise capacity and functional status.	At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty

Countries

United States

Outcome results