Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis
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ClinicalTrials.gov Identifier: NCT00705848 |
Recruitment Status :
Completed
First Posted : June 26, 2008
Last Update Posted : March 21, 2017
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Condition or disease |
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Tracheobronchomalacia Tracheal Stenosis |
- Controlled pilot study to determine whether there exists, at a molecular level, a predisposition to the development of tracheomalacia and subglottic stenosis. Thirty patients will be divided into 2 groups of 20 patients (study patients) and 10 patients (control group). Both groups will undergo bronchoscopy and airway biopsy
- The study is a pilot study to evaluate alterations in the airway matrix, growth factor levels, and vascular structures.in patients with tracheobronchomalacia and subglottic stenosis
- Bronchoscopies will be performed in the West Procedure UnitPulmonary Special Procedures Unit or in the operating room (depending on the clinical indication and patient scheduling) at the BIDMC after informed consent is obtained.
- Patients will receive topical upper airway anesthesia with lidocaine and intravenous conscious sedation with fentanyl and midazolam as per standard of care
- Biopsies will be performed according to standard protocols.
- Biopsies will be performed: 2 samples will be sent for pathology as part of clinical care and 2-3 samples used for research analysis.
Study Type : | Observational |
Actual Enrollment : | 16 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | April 2011 |

Group/Cohort |
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1
10 patients with tracheobronchomalacia
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2
10 patients with tracheal stenosis
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3
10 patients with normal airways (no known airway diseases)
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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): NCT00705848
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Sidhu Gangadharan, M.D. | Beth Israel Deaconess Medical Center |
Responsible Party: | Sidharta Gangadharan, Associate Professor of Surgery, Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00705848 |
Other Study ID Numbers: |
2007P000336 |
First Posted: | June 26, 2008 Key Record Dates |
Last Update Posted: | March 21, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
trachea malacia stenosis |
Tracheobronchomalacia Tracheal Stenosis Constriction, Pathologic Pathological Conditions, Anatomical Tracheal Diseases Respiratory Tract Diseases |
Cartilage Diseases Musculoskeletal Diseases Bronchial Diseases Musculoskeletal Abnormalities Congenital Abnormalities Connective Tissue Diseases |