Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions

Not Applicable

Active, not recruiting

• Conditions: Barotrauma;Ear; Tympanum; Perforation
• Interventions: Behavioral: Maneuver group

• Registration Number: NCT06408363
• Lead Sponsor: Hospital Felicio Rocho

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2024-04-18
• Status Verified: 2024-05
• Primary Completion: 2024-05
• Study First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-10
• Last Update Posted: 2024-05-10
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maneuver group	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.

Primary Outcome Measures

Name	Time	Method
Incidence Reduction of Barotrauma	Until completion of the study, on average 10 months	Patients performing Eustachian tube opening maneuvers will experience a lower incidence of barotrauma

Trial Locations

Locations (1)

Hospital Felicio Rocho; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil