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Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 1, 2025 to Dec 1, 2026v3
  2. Trial status: Active, Not Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: May 2024 to Dec 1, 2025
    • Study completion date: Aug 2024 to Dec 1, 2025
    • Start date: Sep 1, 2023 to May 1, 2023
    • Site details revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Middle ear barotrauma represents the predominant complication associated with hyperbaric oxygen therapy, manifesting symptoms ranging from otalgia to tympanic membrane perforation. Several pressurization protocols have been proposed to reduce the incidence of this trauma, but barotrauma is still the main cause of poor adherence to hyperbaric therapy. Therefore, this study aims to evaluate the effectiveness of serial tubal opening maneuvers to prevent barotrauma in patients undergoing treatment in a hyperbaric chamber.
Trial Details
NCT Number NCT06408363
Lead Sponsor Hospital Felicio Rocho
Conditions
(from sponsor)		 Barotrauma;Ear, Tympanum; Perforation
Related terms Barotrauma, Tympanic Membrane Perforation
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov