Phase 2
N=20
Hyperbaric Oxygen Therapy for Lung Transplantation
Disorder Related to Lung Transplantation · Central Airway Stenosis · Airway Exudative Plaques · Airway Complications Post-Lung Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT02363959 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Oct 2019
Primary outcome: Primary: Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy. — 4; 4 Participants — p=1
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hyperbaric Oxygen Therapy (Drug); Endobronchial Biopsy of Airway Epithelium (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy. |
4; 4 | 1 |
| PRIMARY Number of Subjects Experiencing Acute Cellular Rejection as Determined by Transbronchial Lung Biopsy |
4; 7 | 0.39 |
| SECONDARY Number of Subjects With Development of Clinically Significant Airway Stenosis |
5; 4 | 1 |
| SECONDARY Number of Subjects Receiving Balloon Bronchoplasty for Management of Stenosis |
5; 4 | 1 |
| SECONDARY Number of Subjects With Development of Clinically Significant Lung Infection |
8; 7 | 1 |
| SECONDARY Number of Subjects With Development of Bronchitis Obliterans Syndrome |
0; 1 | 1 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02363959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.