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High-resolution Computed Tomography (HRCT) Evaluation of Airway Distensibility in Lung Transplant Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584181
First Posted: January 2, 2008
Last Update Posted: May 12, 2016
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):
The University of Texas Medical Branch, Galveston
  Purpose
Lung and heart-lung recipients at the University of Texas Medical Branch who have participated in the "Assessment of Cough Reflex in Lung Transplant Recipients" study who meet the specific study inclusion/exclusion criteria will have one study visit where they will undergo lung volume measurements, followed by high resolution CT scan of the lungs within 2 hours. After the initial CT scan, patients will be given a standard dose of Atrovent, followed thirty minutes later by repeat lung volume measurements and CT scan.

Condition
Unspecified Complication of Lung Transplant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Resolution Computed Tomographic Evaluation of Airway Distensibility in Lung Transplant Recipients: A Pilot Study

Resource links provided by NLM:


Further study details as provided by The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • Spirometry changes [ Time Frame: Two hours (before and after inhalation of ipratropium) ]
    Assessment of changes in spirometry following inhalation of nebulized ipratropium


Secondary Outcome Measures:
  • Lung volumes [ Time Frame: Two hours (before and after inhalation of ipratropium) ]
    Assessment of changes in total lung capacity, functional reserve capacity and inspiratory capacity following inhalation of nebulized ipratropium


Other Outcome Measures:
  • Radiographic changes in airway caliber [ Time Frame: Two hours (before and after inhalation of ipratropium) ]
    Assessment of changes in airway caliber as determined by high resolution chest CT images following inhalation of nebulized ipratropium


Estimated Enrollment: 10
Study Start Date: August 2007
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
All eligible patients will undergo the same procedures

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who participated in the "Assessment of Cough Reflex in Lung Transplant Recipients" study who meet the specific inclusion/exclusion criteria for this study
Criteria

Inclusion Criteria:

  • lung transplant recipients >18 years of age
  • at least 12 months or greater from time of transplantation

Exclusion Criteria:

  • hemodynamic instability
  • hypoxemia
  • pneumonia
  • moderate or large pleural effusion
  • clinical evidence of acute rejection
  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): NCT00584181


Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: Alexander G Duarte, MD University of Texas
  More Information

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00584181     History of Changes
Other Study ID Numbers: 07-247
First Submitted: December 20, 2007
First Posted: January 2, 2008
Last Update Posted: May 12, 2016
Last Verified: May 2016