CompletedPhase 2

Hyperbaric Oxygen Therapy for Lung Transplantation

United States20 participantsStarted 2015-02

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 12 months

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

Timeframe: 12 months

Trial details

NCT IDNCT02363959

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-30

Results submitted2019-09-24

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