Hyperbaric Oxygen Therapy for Lung Transplantation

• Status: Completed
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University

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