CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Hyperbaric Oxygen Therapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02363959
NCT02363959Phase 2Completed

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

Duke University·interventional·Posted Feb 16, 2015·Updated Nov 18, 2023

In Brief

A Phase 2 clinical trial evaluating Hyperbaric Oxygen Therapy and Endobronchial Biopsy of Airway Epithelium for Disorder Related to Lung Transplantation and 3 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 16, 2015
Enrollment StartFeb 1, 2015
Primary CompletionSep 30, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.4 years ago

Interventions

Hyperbaric Oxygen Therapydrug

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.

Endobronchial Biopsy of Airway Epitheliumprocedure

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