Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions

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.

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Key information

Conditions

Barotrauma;Ear Barotrauma Ear Diseases Otorhinolaryngologic Diseases Tympanic Membrane Perforation Tympanum; Perforation Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Felicio Rocho

Belo Horizonte, Minas Gerais, 30110-934, Brazil

Location status: Recruiting

Location contact

Alan Rodrigues de Almeida Paiva, MD

CONTACT

[email protected]

+55 31 996869586

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Incidence Reduction of Barotrauma

Time frame: Until completion of the study, on average 10 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alan Rodrigues de Almeida Paiva, MD

CONTACT

[email protected]

+55 31 996869586

Sponsors and collaborators

Lead sponsor

Hospital Felicio Rocho

Other

Registry information

Official study title

Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions: A Randomized Controlled Study

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: May 10, 2024
Registry last updated: Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed