Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions

NCT ID: NCT06408363

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Barotrauma;Ear Tympanum; Perforation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Maneuver group

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.

Group Type EXPERIMENTAL

Maneuver group

Intervention Type 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.

Standard treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Maneuver 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Felicio Rocho

OTHER

Sponsor Role lead

Responsible Party

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Alan Rodrigues de Almeida Paiva

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Felicio Rocho

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Alan Rodrigues de Almeida Paiva, MD

Role: CONTACT

+55 31 996869586

Facility Contacts

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Alan Rodrigues de Almeida Paiva, MD

Role: primary

+55 31 996869586

Other Identifiers

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74381223500005125

Identifier Type: -

Identifier Source: org_study_id

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