Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions

Hospital Felicio Rocho

Status: Enrolling

Conditions: Barotrauma;Ear; Tympanum; Perforation

Treatments: Behavioral: Maneuver group

Study type: Interventional

Funder types: Other

Identifiers

NCT06408363

74381223500005125

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Maneuver group

Experimental group

Description:

Patients in the experimental group will receive detailed training and guidance on pressure equalization techniques and barotrauma prevention measures before undergoing treatment in a hyperbaric chamber. The specific maneuvers to be implemented are outlined below: Toynbee Maneuver: This maneuver involves swallowing with both the mouth and nose closed, thereby reducing the pressure in the nasopharynx and tympanic cavity. Unilateral Passive Valsalva Maneuver: This technique involves occluding one external nasal valve while performing a Valsalva maneuver on the opposite side. These maneuvers 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:

Behavioral: Maneuver group

Standard treatment

No Intervention group

Description:

Patients will receive the standard instructions for the hyperbaric chamber without specific guidance on performing equalization maneuvers.