Hyperbaric Oxygen Therapy for Lung Transplantation
Condition: Disorder Related to Lung Transplantation; Central Airway Stenosis; Airway Exudative Plaques; Airway Complications Post-Lung Transplantation
MeSH terms: Constriction, Pathologic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on
      airway complications in post-lung transplant recipients with evidence of restricted levels of
      blood and oxygen in the airway tissue. Study subjects with extensive airway tissue damage in
      the early post-transplant period will be randomized to HBOT or usual care and followed
      clinically for 12 months following randomization. The investigators hypothesize that HBOT
      will decrease the number of airway complications in the treated subjects.
    

Detailed 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.
    

Intervention name(s): Hyperbaric Oxygen Therapy; Endobronchial Biopsy of Airway Epithelium
Intervention type(s): Drug; Procedure
Intervention description(s): 2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at 2 ATA 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.; During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.
Other intervention name(s): HBOT; Hyperbaric Oxygen; Airway Biopsy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperbaric Oxygen; Lung Transplantation; Central Airway Stenosis; Airway Exudative Plaques; Hyperbaric Oxygen Therapy; Post-Lung Transplantation; Airway Ischemia; Endobronchial Biopsy; Bronchoscopy