Trials / Recruiting
RecruitingNCT06408363
Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions
Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions: A Randomized Controlled Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Hospital Felicio Rocho · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Maneuver group | These maneuvers for Eustachian tube opening will be performed continuously during the compression phase of the hyperbaric chamber, every 30 minutes after reaching the desired pressurization level, and continuously during the decompression phase. |
Timeline
- Start date
- 2023-05-01
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2024-05-10
- Last updated
- 2026-02-09
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT06408363. Inclusion in this directory is not an endorsement.