Barotrauma;Ear, Tympanum; Perforation
Conditions
Keywords
Barotrauma, Tympanic Membrane Perforation, Eustachian Tube, Hyperbaric Oxygenation
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.
Interventions
BEHAVIORALManeuver 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.
Sponsors
Hospital Felicio Rocho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Reduction of Barotrauma | Until completion of the study, on average 10 months | Patients performing Eustachian tube opening maneuvers will experience a lower incidence of barotrauma |
Countries
Brazil
Contacts
CONTACTAlan Rodrigues de Almeida Paiva, MD
Outcome results
None listed