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Completed

NCT Number: NCT02363959

Hyperbaric Oxygen Therapy for Lung Transplantation

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric Oxygen Therapy

Drug

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

Endobronchial Biopsy of Airway Epithelium

Procedure

During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.

Other names: Airway Biopsy

Primary outcomes

  1. Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy.

    Time frame: 12 months

    Airways with stenosis refractory to serial balloon dilation x 3, or at risk for acute obstruction due to stenosis were treated with airway stents.

  2. Number of Subjects Experiencing Acute Cellular Rejection as Determined by Transbronchial Lung Biopsy

    Time frame: 12 months

    Pathologic specimens will be examined for the presence of acute cellular rejection.

Secondary outcomes

  1. Number of Subjects With Development of Clinically Significant Airway Stenosis

    Time frame: 12 months

  2. Number of Subjects Receiving Balloon Bronchoplasty for Management of Stenosis

    Time frame: 12 months

  3. Number of Subjects With Development of Clinically Significant Lung Infection

    Time frame: 12 months

    As defined by initiation of antimicrobials to treat the suspected organism.

  4. Number of Subjects With Development of Bronchitis Obliterans Syndrome

    Time frame: 12 months

Other outcomes

  1. Bronchial Epithelial Gene Expression

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Hyperbaric Oxygen Therapy for Lung Transplantation-Associated Pseudomembranes and Central Airway Stenosis

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 16, 2015
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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