Clinical trial NCT00550602: Tracheobronchomalacia: Treatment Outcomes
Official title: Tracheobronchomalacia: Treatment Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheomalacia
Tracheobronchomalacia
Keywords: Tracheomalacia
Tracheobronchomalacia
Airway Stabilization
Bronchoscopy
Stent Placement
Tracheobronchoplasty
COPD
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2007-10-30
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population with suspected symptomatic tracheal and/or bronchial collapse referred to our institution by a Pulmonologist or Thoracic Surgeon.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia.
timeFrame: At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty
Secondary outcomes:
measure: To evaluate the effect of central airway stabilization on lung function, exercise capacity and functional status.
timeFrame: At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center- Division of Interventional Pulmonology
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Armin Ernst, M.D. FCCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ernst A, Majid A, Feller-Kopman D, Guerrero J, Boiselle P, Loring SH, O'Donnell C, Decamp M, Herth FJ, Gangadharan S, Ashiku S. Airway stabilization with silicone stents for treating adult tracheobronchomalacia: a prospective observational study. Chest. 2007 Aug;132(2):609-16. doi: 10.1378/chest.06-2708.
citation: Ernst A, Odell DD, Michaud G, Majid A, Herth FFJ, Gangadharan SP. Central airway stabilization for tracheobronchomalacia improves quality of life in patients with COPD. Chest. 2011 Nov;140(5):1162-1168. doi: 10.1378/chest.10-3051. Epub 2011 Aug 25.
citation: Odell DD, Shah A, Gangadharan SP, Majid A, Michaud G, Herth F, Ernst A. Airway stenting and tracheobronchoplasty improve respiratory symptoms in Mounier-Kuhn syndrome. Chest. 2011 Oct;140(4):867-873. doi: 10.1378/chest.10-2010. Epub 2011 Apr 14.
citation: Majid A, Guerrero J, Gangadharan S, Feller-Kopman D, Boiselle P, DeCamp M, Ashiku S, Michaud G, Herth F, Ernst A. Tracheobronchoplasty for severe tracheobronchomalacia: a prospective outcome analysis. Chest. 2008 Oct;134(4):801-807. doi: 10.1378/chest.08-0728.