Hyperbaric Oxygen Therapy for Lung Transplantation-Associated Pseudomembranes and Central Airway Stenosis
Description:
Hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at
Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing >99%
medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 once a
day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the
availability of the patient and the hyperbaric medicine physician. The HBOT procedure used
for this study will be identical to that used for clinical practice in the Duke University
Health System Center for Hyperbaric Medicine and Environmental Physiology, including the
oxygen that is used in the chamber. Patients will receive treatment through the regular
clinical hyperbaric service. These are routine, not special, treatment sessions and they will
receive them alongside other Duke University Medical Center patients being treated for other
reasons. The medical grade oxygen used is a part of the Duke University Health System Center
for Hyperbaric Medicine and Environmental Physiology hyperbaric chamber system.
While the patients randomized to receive usual care will not undergo HBOT, both study groups
will receive standard serial bronchoscopies for airway clearance and for the collection of
bronchoalveolar lavage fluid for culture data, due to the high rate of infection in lung
transplant patients. All subjects will undergo the standard surveillance bronchoscopies every
3 to 4 weeks (x3) for clearance of the exudate from the airway, as well as monitoring
progression of the airway abnormalities. As participants in this study, an, endobronchial
biopsy of the airway epithelium will be performed at the main carina to collect a sample of
recipient epithelium as well as at the first subcarina for each donor lung. Three samples
will be collected from each of the biopsy sites. These samples are small (1 to 2 mm) and are
thought to have a minimal clinical risk of minor bleeding associated with the procedure.
Biopsy will add roughly 3 minutes total to each procedure.
Condition:
Disorder Related to Lung Transplantation
Treatment:
Hyperbaric Oxygen Therapy
Start Date:
February 2015
Sponsor:
Duke University
For More Information:
https://clinicaltrials.gov/show/NCT02363959