NCT06408363 Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions
| NCT ID | NCT06408363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Felicio Rocho |
| Condition | Barotrauma;Ear |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2026-12-01 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patient undergoing the first hyperbaric session. * Understanding and properly carrying out equalization maneuvers Exclusion Criteria: * Patients who did not understand the equalization maneuvers * Patients with specific contraindications to hyperbaric therapy * Patients with acute middle ear or tympanic membrane disease