Hyperbaric Oxygen Therapy for Lung Transplantation

NCT02363959 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00055849
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Number of Subjects With Development of Clinically Significant Airway Stenosis

  12 months

• Number of Subjects Receiving Balloon Bronchoplasty for Management of Stenosis

  12 months

• Number of Subjects With Development of Clinically Significant Lung Infection

  12 months

• Number of Subjects With Development of Bronchitis Obliterans Syndrome

  12 months

Other Outcomes (1)

• Bronchial Epithelial Gene Expression

  12 months

Study Arms (2)

Hyperbaric Oxygen, Airway Biopsy

EXPERIMENTAL

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; Procedure: Endobronchial Biopsy of Airway Epithelium

No Hyperbaric Oxygen, Airway Biopsy

OTHER

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

Interventions

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.

Also known as: HBOT, Hyperbaric Oxygen

Hyperbaric Oxygen, Airway Biopsy

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.

Also known as: Airway Biopsy

Hyperbaric Oxygen, Airway Biopsy; No Hyperbaric Oxygen, Airway Biopsy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related 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 2021 Jan 15.

  PMID: 33518452 RESULT

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Results Point of Contact

• Title: Scott Shofer MD, PhD
• Organization: Duke University

scott.shofer@duke.edu

919-668-2402

Study Officials

• Scott Shofer

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 16, 2015
• Study Start: February 1, 2015
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: November 18, 2023
• Results First Posted: October 17, 2019

Record last verified: 2023-11

Locations

US (1)