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Feasibility and Safety of Supraglottic Oxygen Delivery Via an Endotracheal Tube for Non-intubated ERCP Anesthesia: A Two-Stage Phase II Clinical Study

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2, 2025 to Jun 12, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2, 2025 to Jun 12, 2025
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Endoscopic retrograde cholangiopancreatography (ERCP) is a technique for evaluating the bile duct, pancreatic duct, and ampulla. Hypoxia is the most common cardiopulmonary complication during ERCP, with a reported rate of 16.2 to 39.2%. The key to preventing hypoxia is to ensure the sufficient oxygenation and ventilation of patients during these procedures. The commonly used approaches to treat hypoxia with a non-instrumented airway are increasing the oxygen flow and lifting the jaw, applying with both hands, displacing the jaw upwards and anteriorly, which allowed the upper airway to remain open. We hypothesized that the supraglottic oxygen delivery via an endotracheal tube can reduce the incidence of hypoxia in patients under deep sedation during ERCP.
Trial Details
NCT Number NCT07051980
Lead Sponsor Zhejiang University
Conditions Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice, Pancreatitis, Cholelithiasis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov