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

This study is currently recruiting participants.
Verified July 2013 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: July 15, 2013
Last verified: July 2013
  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
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: July 15, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014