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



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:2/23/2018
Start Date:August 2007
End Date:January 7, 2018

Use our guide to learn which trials are right for you!

High Resolution Computed Tomographic Evaluation of Airway Distensibility in Lung Transplant Recipients: A Pilot Study

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.

Chest CT imaging will be obtained in the radiology department at UTMB. After the initial
screening visit, subjects will visit the pulmonary function laboratory where they will
undergo spirometry and measurement of lung volumes by whole body plethysmography. Within two
hours of pulmonary function testing, subjects will undergo an initial HRCT scan. After the
initial HRCT, subjects will inhale a standard dose of ipratropium bromide (0.5 mg) using a
hand held nebulizer. Thirty minutes after ipratropium bromide administration, spirometry will
be measured followed by a second HRCT scan.

Spirometry measurements will be performed in triplicate with the subjects in a seated
position using a portable Koko spirometer (PDS, Louisville, CO). After the spirometry
measurements, lung volumes will be measured in a body plethysmograph (MedGraphics, St. Paul,
MN) with the subjects in a seated position with a nose clip. Subjects will be instructed to
pant against the closed shutter at a frequency of 1-3 Hz. Lung volume measurements will be
obtained prior to inital chest CT. Subjects will undergo high resolution computed tomography
(HRCT) scanning within 30 minutes of initial lung volume measurements.

After the initial HRCT of the chest, subjects will inhale a dose of nebulized ipratropium
bromide (0.5 mg) by standard nebulizer after which spirometry and lung volume measurements
will be repeated in the pulmonary function laboratory. Spirometry and lung volume
measurements will be performed in the same manner. Lung volume measurements will be obtained
to account for changes in lung volumes after bronchodilator administration. Changes in lung
volumes will be used to account for any changes noted on HRCT scans.

HRCT scanning will begin 6 cm above the top of the dome of the diaphragm, at TLC and moved
caudally. Images will be reconstructed with the use of a high-spatial frequency (resolution)
algorithm that enhanced edge detection, at a window level of -450 Hounsfield units and a
window width of 1,350 Hounsfield units. We will consider the airway diameters after maximum
bronchodilation with ipratropium to be a function principally of the structural
characteristics of airways. The TLC measurements after ipratropium will be the best
reflection of intrinsic structure. CT airway measurement analysis will be performed by VIDA
Diagnostics. We have entered into a collaboration with VIDA Diagnostics that will allow
accurate and reliable CT airway measurements. Subject's CT images obtained at UTMB will be
deidentified and electronically transmitted to a research collaborator at VIDA Diagnostics
located in Coralville, IA. The CT images will have a code assigned, known only to the PI.
Using a proprietary software platform, airway measurements will be performed and the data
electronically transmitted to the PI at UTMB.

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
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
?
mi
from
Galveston, TX
Click here to add this to my saved trials