Hyperbaric oxygen therapy to prevent central airway stenosis after lung transplantation
Section snippets
Subject selection
The study protocol was approved by the Duke Institutional Review Board (Pro00055849) and posted on www.clintrials.gov (NCT02363959). All subjects provided written informed consent before study procedures. Subjects were eligible for the study if they had developed extensive (Stage 3–4) (refer to Supplementary Table S1 available online at www.jhltonline.org) post-transplant airway necrosis10 after lung transplantation that did not spontaneously resolve after 2 to 3 weeks. Subjects were excluded
Results
A total of 20 subjects (11 males, 9 females) who were transplanted in the previous 4.6 (4–5.6) weeks were enrolled and randomized to either usual care (n = 10) or HBOT (n = 10). Age and sex distributions were comparable between the groups: 54.5 (36–65) vs 59.7 (41–62) years and 50% vs 40% female, respectively. Individual subject characteristics are shown in Table 1. A total of 2 subjects were screened but not randomized owing to transplant-related complications developed before study activities
Discussion
We report a randomized, controlled trial comparing HBOT with usual care in treating established airway necrosis after lung transplantation. Although many clinical factors are known to contribute to ischemic airway complications, such as hypotension, prolonged mechanical ventilation, infection, primary graft dysfunction, and ACR,1,2,6,22, 23, 24 our hypothesis was that HBOT might improve donor bronchial mucosal healing and reduce the incidence of CAS and the need for stenting. However, the study
Disclosure statement
B.D.K. reports funding from the National Institutes of Health/National Heart, Lung, and Blood Institute (K08HL130557). The remaining authors have no conflicts of interest to disclose.
The authors thank the chamber operators, nurses, and physicians at the Duke Center for Hyperbaric Medicine and Environmental Physiology (Durham, NC) for assistance with this study and thank the Duke Lung Transplant clinical coordinators and patient care providers.
The study was funded by Duke Pulmonary Divisional
Authors contributions
All authors approved the draft and overall research plan of the manuscript. All authors are accountable for the submitted work.
Concept and design: S.L.S.
Acquisition, analysis, or interpretation of data: B.D.K., K.M., N.P.H., M.G.H., L.D.S., H.B.S., S.L.S.
Drafting of the manuscript: B.D.K. and K.M.
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These authors have contributed equally to this work.