Tracheobronchomalacia: Treatment Outcomes
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Purpose
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).
| Condition |
|---|
|
Tracheomalacia Tracheobronchomalacia |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Tracheobronchomalacia: Treatment 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2002 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adult population with suspected symptomatic tracheal and/or bronchial collapse referred to our institution by a Pulmonologist or Thoracic Surgeon.
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
Contacts and Locations| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center- Division of Interventional Pulmonology | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Armin Ernst, M.D. FCCP | Beth Israel Deaconess Medical Center |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Armin Ernst, MD, BIDMC |
| ClinicalTrials.gov Identifier: | NCT00550602 History of Changes |
| Other Study ID Numbers: | 2005P-000112 |
| Study First Received: | October 26, 2007 |
| Last Updated: | April 21, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Beth Israel Deaconess Medical Center:
|
Tracheomalacia Tracheobronchomalacia Airway Stabilization Bronchoscopy |
Stent Placement Tracheobronchoplasty COPD |
Additional relevant MeSH terms:
|
Tracheobronchomalacia Tracheomalacia Cartilage Diseases Musculoskeletal Diseases Bronchial Diseases |
Respiratory Tract Diseases Tracheal Diseases Musculoskeletal Abnormalities Congenital Abnormalities Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 16, 2013