Tracheobronchomalacia: Treatment Outcomes

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00550602
First received: October 26, 2007
Last updated: April 21, 2010
Last verified: April 2010
  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

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 ] [ Designated as safety issue: No ]

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 ] [ 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)
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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 July 29, 2014