Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions

Barotrauma;Ear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06408363
• Other study ID #: 74381223500005125
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Hospital Felicio Rocho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Barotrauma
• Barotrauma;Ear
• Tympanic Membrane Perforation
• Tympanum; Perforation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Felicio Rocho	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Felicio Rocho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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