Clinical trial

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

Name

Pro00055849

Description

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.

Trial arms

Trial start

2015-02-01

Estimated PCD

2018-09-30

Trial end

2018-09-30

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Hyperbaric Oxygen, Airway Biopsy

Other names:

HBOT, Hyperbaric Oxygen

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.

Arms:

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

Other names:

Airway Biopsy

Size

Primary endpoint

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

12 months

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

12 months

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

Updated at

2023-11-18

1 organization

1 product

4 indications

Organization

Duke University

Product

Hyperbaric Oxygen Therapy

Indication

Lung Transplantation

Indication

tracheal stenosis

Indication

Airway Exudative Plaques

Indication

Airway complications post-lung transplantation