Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00705848
First received: June 24, 2008
Last updated: June 13, 2011
Last verified: June 2011
  Purpose

It is not clearly understood what causes tracheobronchomalacia (weakening of the windpipe and airways) or tracheal stenosis (narrowing of the windpipe). We plan to take biopsies (small pieces of tissue) and brushings (to collect the cells that form the lining of the airway) from the airways of patients with these diseases and analyze these samples in a laboratory to try and determine the mechanism of disease. We will compare the results with that of patients with normal airways.


Condition
Tracheobronchomalacia
Tracheal Stenosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis

Resource links provided by NLM:


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

Biospecimen Retention:   Samples With DNA

Airway biopsies and brushings are to be used for staining and culture, respectively


Estimated Enrollment: 30
Study Start Date: July 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
10 patients with tracheobronchomalacia
2
10 patients with tracheal stenosis
3
10 patients with normal airways (no known airway diseases)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with tracheobronchomalacia or tracheal stenosis referred to this tertiary care facility

Criteria

Inclusion Criteria:

  • (study group): age ≥ 18, willingness and ability to give informed consent, clinical indication for bronchoscopy and biopsy, prior bronchoscopic diagnosis of tracheobronchomalacia, prior bronchoscopic diagnosis of subglottic stenosis (either idiopathic or post-intubation), and smoking cessation for ≥ 4 months. There is no gender or racial restriction. Pregnant women will not be included in the study because of the potential for hypoxemia (especially fetal) and prolongation of the procedure if complications arise. Patients must have family/friends to drive them home following the procedure.
  • (control group): age ≥ 18, willingness and ability to give informed consent, clinical indication for bronchoscopy and biopsy, no prior diagnosis of any airway disease of any etiology, and smoking cessation for ≥ 4 months. There is no gender or racial restriction. Pregnant women will not be included in the study because of the potential for hypoxemia (especially fetal) and prolongation of the procedure if complications arise. Patients must have family/friends to drive them home following the procedure.

Exclusion Criteria:

  • (study group): pre-existing airway disorders other than tracheobronchomalacia or subglottic stenosis, etiology of subglottic stenosis other than idiopathic or post-intubation, pulmonary vascular disease, inability to tolerate intravenous conscious sedation.
  • (control group): any pre-existing airway disorder, pulmonary vascular disease, and inability to tolerate intravenous conscious sedation.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00705848

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Sidhu Gangadharan, M.D. Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Sidhu Gangadharan, M.D., Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00705848     History of Changes
Other Study ID Numbers: 2007P-000336
Study First Received: June 24, 2008
Last Updated: June 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
trachea
malacia
stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Tracheobronchomalacia
Tracheal Stenosis
Pathological Conditions, Anatomical
Cartilage Diseases
Musculoskeletal Diseases
Bronchial Diseases
Respiratory Tract Diseases
Tracheal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 16, 2014