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Tracheal Mechanics During Bronchoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536315
First Posted: September 27, 2007
Last Update Posted: March 10, 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 (Responsible Party):
Stephen Loring, Beth Israel Deaconess Medical Center
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tracheal Mechanics During Bronchoscopy

Resource links provided by NLM:


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

Enrollment: 145
Actual Study Start Date: March 1, 1999
Study Completion Date: June 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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

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:   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
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): NCT00536315


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: Stephen H Loring, M.D. Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Stephen Loring, Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00536315     History of Changes
Other Study ID Numbers: 2001P001418
First Submitted: September 26, 2007
First Posted: September 27, 2007
Last Update Posted: March 10, 2017
Last Verified: February 2010

Keywords provided by Stephen Loring, Beth Israel Deaconess Medical Center:
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