Tracheobronchomalacia: Treatment Outcomes

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tracheomalacia Bronchial Diseases Cartilage Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Disease Attributes Lung Diseases Lung Diseases, Obstructive Musculoskeletal Abnormalities Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Skin and Connective Tissue Diseases Tracheal Diseases Tracheobronchomalacia

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center- Division of Interventional Pulmonology

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia.

Time frame: At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty

Secondary outcomes

To evaluate the effect of central airway stabilization on lung function, exercise capacity and functional status.

Time frame: At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start: 2002
Primary completion: 2010
Study completion: 2010
First posted: Oct 30, 2007
Registry last updated: Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed