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Tracheobronchomalacia: Treatment Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00550602
First Posted: October 30, 2007
Last Update Posted: February 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Beth Israel Deaconess Medical Center
  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: Observational Model: Other
Time Perspective: Prospective
Official Title: Tracheobronchomalacia: Treatment Outcomes

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

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)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550602


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center- Division of Interventional Pulmonology
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Armin Ernst, M.D. FCCP Beth Israel Deaconess Medical Center
  More Information

Publications:
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: 2005P000112
First Submitted: October 26, 2007
First Posted: October 30, 2007
Last Update Posted: February 3, 2017
Last Verified: April 2010

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