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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The University of Texas, Galveston
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00584181
First received: December 20, 2007
Last updated: May 27, 2014
Last verified: May 2014
  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
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, Galveston:

Primary Outcome Measures:
  • Spirometry changes [ Time Frame: Two hours (before and after inhalation of ipratropium) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
All eligible patients will undergo the same procedures

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584181

Contacts
Contact: Alexander G Duarte, MD 409-772-2436 aduarte@utmb.edu

Locations
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Alexander G Duarte, MD    409-772-2436    aduarte@utmb.edu   
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Alexander G Duarte, MD University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00584181     History of Changes
Other Study ID Numbers: 07-247
Study First Received: December 20, 2007
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 26, 2014