Clinical trial NCT02363959: Hyperbaric Oxygen Therapy for Lung Transplantation
Official title: Hyperbaric Oxygen Therapy for Lung Transplantation-Associated Pseudomembranes and Central Airway Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Disorder Related to Lung Transplantation
Central Airway Stenosis
Airway Exudative Plaques
Airway Complications Post-Lung Transplantation
Keywords: Hyperbaric Oxygen
Lung Transplantation
Central Airway Stenosis
Airway Exudative Plaques
Hyperbaric Oxygen Therapy
Post-Lung Transplantation
Airway Ischemia
Endobronchial Biopsy
Bronchoscopy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Post-lung transplant patient
* Extensive exudative plaques at 1 month bronchoscopy
* No sign of airway improvement, or showing worsening of plaques at follow-up bronchoscopy 2-3 weeks after 1 month bronchoscopy.

Exclusion Criteria:

* Use of mechanical ventilation with fraction of inspired oxygen(FiO2) greater than 40%
* Use of extracorporeal membrane oxygenation
* Use of inhaled nitric oxide
* Presence of pneumothorax
* Pregnancy
* Inability to provide informed consent

Primary outcomes:
measure: Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy.
timeFrame: 12 months
measure: Number of Subjects Experiencing Acute Cellular Rejection as Determined by Transbronchial Lung Biopsy
timeFrame: 12 months
Secondary outcomes:
measure: Number of Subjects With Development of Clinically Significant Airway Stenosis
timeFrame: 12 months
measure: Number of Subjects Receiving Balloon Bronchoplasty for Management of Stenosis
timeFrame: 12 months
measure: Number of Subjects With Development of Clinically Significant Lung Infection
timeFrame: 12 months
measure: Number of Subjects With Development of Bronchitis Obliterans Syndrome
timeFrame: 12 months
Other outcomes:
measure: Bronchial Epithelial Gene Expression
timeFrame: 12 months
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Scott Shofer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraft BD, Mahmood K, Harlan NP, Hartwig MG, Snyder LD, Suliman HB, Shofer SL. Hyperbaric oxygen therapy to prevent central airway stenosis after lung transplantation. J Heart Lung Transplant. 2021 Apr;40(4):269-278. doi: 10.1016/j.healun.2021.01.008. Epub 2021 Jan 15.