Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHospital Felicio Rocho
About this trial
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
This trial accepts healthy volunteersQualifiers
Patient undergoing the first hyperbaric session.
Understanding and properly carrying out equalization maneuvers
Disqualifiers
Patients who did not understand the equalization maneuvers
Patients with specific contraindications to hyperbaric therapy
Patients with acute middle ear or tympanic membrane disease
Trial design
Design model
Parallel
Treatments tested in this trial
Maneuver group
BehavioralThese 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Maneuver groupExperimental treatment 1 intervention
Group B: Standard treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence Reduction of Barotrauma
Patients performing Eustachian tube opening maneuvers will experience a lower incidence of barotrauma
Time frame
Until completion of the study, on average 10 monthsSponsors and contacts
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Source ClinicalTrials.gov