Clinical Trial

Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions

Recruiting
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-06; most recent amendment 2026-02-05.
Status change: Active, Not Recruiting → Recruiting 2025-06-17
Trial Details
NCT Number NCT06408363
Lead Sponsor Hospital Felicio Rocho
Conditions Barotrauma;Ear, Tympanum; Perforation
Enrollment 100 participants
Start Date 2023-05-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-09