Hyperbaric Oxygen Therapy for Lung Transplantation

Disorder Related to Lung Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363959
• Other study ID #: Pro00055849
• Status: Completed
• Phase: Phase 2
• Start date: February 2015
• Est. completion date: September 30, 2018

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Complications Post-Lung Transplantation
• Airway Exudative Plaques
• Central Airway Stenosis
• Constriction, Pathologic
• Disorder Related to Lung Transplantation

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bronchial Epithelial Gene Expression		12 months
Primary	Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy.	Airways with stenosis refractory to serial balloon dilation x 3, or at risk for acute obstruction due to stenosis were treated with airway stents.	12 months
Primary	Number of Subjects Experiencing Acute Cellular Rejection as Determined by Transbronchial Lung Biopsy	Pathologic specimens will be examined for the presence of acute cellular rejection.	12 months
Secondary	Number of Subjects With Development of Clinically Significant Airway Stenosis		12 months
Secondary	Number of Subjects Receiving Balloon Bronchoplasty for Management of Stenosis		12 months
Secondary	Number of Subjects With Development of Clinically Significant Lung Infection	As defined by initiation of antimicrobials to treat the suspected organism.	12 months
Secondary	Number of Subjects With Development of Bronchitis Obliterans Syndrome		12 months