Selected article for: "clinical trial and data model"

Author: Raman, Vignesh; Ofoche, Obinna G; Chentorycki, Daniel J; Erkmen, Cherie P
Title: Cadaveric validation of porcine model suggests noninvasive positive pressure ventilation may be safe following esophagectomy.
  • Cord-id: 1raeqdh8
  • Document date: 2015_1_1
  • ID: 1raeqdh8
    Snippet: BACKGROUND We previously used a pig model to demonstrate that noninvasive positive pressure ventilation (NPPV) may be a safe alternative to endotracheal intubation (ET). We sought to validate our model by quantifying the pressure threshold of esophageal anastomoses in human cadavers as a step before a clinical trial. METHODS We performed stapled side-to-side, functional end-to-end esophageal anastomoses in 10 cadaveric specimens from autopsy. With intraluminal pressure monitoring, we insufflated
    Document: BACKGROUND We previously used a pig model to demonstrate that noninvasive positive pressure ventilation (NPPV) may be a safe alternative to endotracheal intubation (ET). We sought to validate our model by quantifying the pressure threshold of esophageal anastomoses in human cadavers as a step before a clinical trial. METHODS We performed stapled side-to-side, functional end-to-end esophageal anastomoses in 10 cadaveric specimens from autopsy. With intraluminal pressure monitoring, we insufflated the anastomosis with air until a leak was observed, and measured the maximum tolerated pressure. RESULTS Cadaveric esophageal anastomoses tolerated 101±39 cmH2O (range, 63-140 cmH2O) of pressure before leak was observed. The maximum pressure threshold ranged from 59 to 246 cmH2O. The leak was always at the anastomosis. There was no significant difference in pressure threshold between cadaveric and previously described porcine anastomoses. CONCLUSIONS We created a human cadaveric model that in conjunction with our porcine data demonstrates that a human esophageal anastomosis can tolerate manifold higher pressures than are delivered to the esophagus by NPPV. This is the final step before a trial of NPPV in patients following esophagectomy.

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