Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Maneuver group.
- Who it may be relevant to
- Registry conditions: Barotrauma;Ear, Tympanum; Perforation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions: A Randomized Controlled Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Incidence Reduction of Barotrauma [Time frame: Until completion of the study, on average 10 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Brazil · 1 center
- Hospital Felicio Rocho — Belo Horizonte
Identifiers
NCT: NCT06408363 · 74381223500005125