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First Human Trial Finds Enteral Ventilation Safe and Tolerable

The study establishes tolerability in healthy adults to enable upcoming efficacy tests with oxygenated perfluorodecalin.

Overview

  • Researchers reported in Med that 27 healthy men in Japan received a single intrarectal dose of non-oxygenated perfluorodecalin, up to 1,500 ml, retained for 60 minutes.
  • Twenty participants completed the full hour, with only mild abdominal bloating and discomfort at the highest volume, no serious adverse events, and normal laboratory results.
  • The team, led by Takanori Takebe of Cincinnati Children’s and the University of Osaka, emphasized that the data address safety only and not oxygen delivery effectiveness.
  • Next studies will use fully oxygenated perfluorodecalin to measure blood-oxygen increases, guided by predictions from large-animal models.
  • The work, which follows prior porcine research and 2024 IgNobel recognition, is being advanced by EVA Therapeutics, with future trial timing dependent on fundraising and a potential role as an adjunct for severe respiratory compromise if efficacy is shown.