Tracheal Mechanics During Bronchoscopy

This study is currently recruiting participants.

Verified by Beth Israel Deaconess Medical Center, August 2008

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00536315

Purpose

The main purpose of this study is use a new type of measurement to help decide what kind of therapy would help people with a collapsing windpipe or tracheomalacia.

Condition
Tracheomalacia Tracheobronchomalacia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Tracheal Mechanics During Bronchoscopy

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	March 1999
Estimated Study Completion Date:	September 2009

Groups/Cohorts
COPD Patients with cough and/or shortness of breath who may have windpipe collapse.
Healthy adults Subjects without symptoms for comparison.
Tracheomalacia Patients with cough and/or shortness of breath who may have windpipe collapse.

Detailed Description:

This study is to obtain new information about the pressures required to collapse the trachea in patients with and without obstructive pulmonary disease and to describe the relationship between pressures and airflow obstruction. This information will provide normative data not currently available and would establish whether tracheal collapse is due to tracheomalacia. The data may lead to better ways of predicting if a patient would benefit from procedures to prevent tracheal collapse.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy control subjects recruited from subjects volunteering for CT or bronchoscopic studies and patients referred for evaluation of possible tracheomalacia.

Criteria

Inclusion Criteria:

Suspicion of tracheal collapse undergoing bronchoscopy
Healthy control subject undergoing bronchoscopy for another purpose.

Exclusion Criteria:

Esophageal pathology
Tracheostomy
inability to follow commands

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536315

Contacts

Contact: Stephen H Loring, M.D.	617-667-3092	sloring@bidmc.harvard.edu
Contact: Phillip M Boiselle, M.D.	(617) 754-2653	pboisell@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Stephen H Loring, M.D.

Beth Israel Deaconess Medical Center

More Information

Publications of Results:

Loring SH, O'donnell CR, Feller-Kopman DJ, Ernst A. Central airway mechanics and flow limitation in acquired tracheobronchomalacia. Chest. 2007 Apr;131(4):1118-24.

Responsible Party:	BIDMC ( Stephen H. Loring )
Study ID Numbers:	2001-P-001418
Study First Received:	September 26, 2007
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00536315
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

COPD

Study placed in the following topic categories:

Tracheobronchomalacia

ClinicalTrials.gov processed this record on January 15, 2009