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Tracheal Mechanics During Bronchoscopy

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ClinicalTrials.gov Identifier: NCT00536315
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Stephen Loring, Beth Israel Deaconess Medical Center

Brief Summary:
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 or disease
Tracheomalacia Tracheobronchomalacia

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.

Study Type : Observational
Actual Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tracheal Mechanics During Bronchoscopy
Actual Study Start Date : March 1, 1999
Actual Primary Completion Date : July 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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.




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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

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

Publications of Results:
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 Posted: September 27, 2007    Key Record Dates
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