Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions

NCT06408363 | Recruiting

• 1 other identifier: 74381223500005125
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Barotrauma;Ear; Tympanum; Perforation

Keywords

Barotrauma; Tympanic Membrane Perforation; Eustachian Tube; Hyperbaric Oxygenation

Outcome Measures

Primary Outcomes (1)

• Incidence Reduction of Barotrauma

  Patients performing Eustachian tube opening maneuvers will experience a lower incidence of barotrauma

  Until completion of the study, on average 10 months

Study Arms (2)

Maneuver group

EXPERIMENTAL

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.

Behavioral: Maneuver group

Standard treatment

NO INTERVENTION

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

Interventions

Maneuver group BEHAVIORAL

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.

Maneuver group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing the first hyperbaric session.
• Understanding and properly carrying out equalization maneuvers

You may not qualify if:

• Patients who did not understand the equalization maneuvers
• Patients with specific contraindications to hyperbaric therapy
• Patients with acute middle ear or tympanic membrane disease

Sponsors & Collaborators

• Hospital Felicio Rocho: lead

Study Sites (1)

Hospital Felicio Rocho

Belo Horizonte, Minas Gerais, 30110-934, Brazil

RECRUITING

MeSH Terms

Conditions

Tympanic Membrane Perforation; Barotrauma

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Central Study Contacts

Alan Rodrigues de Almeida Paiva, MD

CONTACT

+55 31 996869586; alanrodriguesmd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: May 10, 2024
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2025-06

Locations

BR (1)