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First Human Trial Finds Enteral Ventilation Procedure Tolerable in Healthy Volunteers

Researchers report perfluorodecalin enemas were tolerated by 27 men, setting up Phase II tests of oxygenated liquid in hypoxemic patients.

Overview

  • The study in Med tested intrarectal administration of non‑oxygenated perfluorodecalin for 60 minutes in 27 healthy male volunteers.
  • No serious adverse events were observed, with mild, transient bloating the most common complaint and vital signs remaining stable.
  • Doses up to 1,000 mL were deemed tolerable; some participants receiving higher volumes reported discomfort, and seven did not complete the full hour.
  • The trial evaluated safety only, so whether the method can raise blood oxygen levels in humans remains unproven.
  • Investigators plan Phase II trials of oxygenated perfluorodecalin with clinical partners in Japan and the United States as a potential bridge therapy for respiratory failure.