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Hyperbaric Oxygen Therapy for Lung Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02363959
First received: February 10, 2015
Last updated: November 28, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Disorder Related to Lung Transplantation
Central Airway Stenosis
Airway Exudative Plaques
Airway Complications Post-Lung Transplantation
Drug: Hyperbaric Oxygen Therapy
Procedure: Endobronchial Biopsy of Airway Epithelium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy for Lung Transplantation-Associated Pseudomembranes and Central Airway Stenosis

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Need for airway stent placement as determined by transbronchial lung biopsy [ Time Frame: 12 Months ]
  • Rate of acute rejection as determined by transbronchial lung biopsy [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Development of airway stenosis [ Time Frame: 12 months ]
  • Need for balloon bronchoplasty [ Time Frame: 12 months ]
  • Development of clinically significant lung infection [ Time Frame: 12 months ]
    As defined by initiation of antimicrobials to treat the suspected organism

  • Development of bronchitis obliterans syndrome [ Time Frame: 12 months ]
  • Bronchial epithelial gene expression [ Time Frame: 12 months ]

Estimated Enrollment: 40
Study Start Date: February 2015
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperbaric Oxygen, Airway Biopsy

The 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 (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 bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.

Drug: Hyperbaric Oxygen Therapy
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.
Other Names:
  • HBOT
  • Hyperbaric Oxygen
Procedure: Endobronchial Biopsy of Airway Epithelium
During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.
Other Name: Airway Biopsy
No Hyperbaric Oxygen, Airway Biopsy
No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.
Procedure: Endobronchial Biopsy of Airway Epithelium
During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.
Other Name: Airway Biopsy

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

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02363959

Contacts
Contact: Scott L Shofer, MD, PhD 919-286-0411 ext 8291 scott.shofer@duke.edu
Contact: Scott Shofer, MD, PhD 919-668-2402 scott.shofer@dm.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Scott Shofer, MD    919-668-2402    scott.shofer@dm.duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Scott Shofer Duke University Health System
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02363959     History of Changes
Other Study ID Numbers: Pro00055849
Study First Received: February 10, 2015
Last Updated: November 28, 2016

Keywords provided by Duke University:
Hyperbaric Oxygen
Lung Transplantation
Central Airway Stenosis
Airway Exudative Plaques
Hyperbaric Oxygen Therapy
Post-Lung Transplantation
Airway Ischemia
Endobronchial Biopsy
Bronchoscopy

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 25, 2017