Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions: A Randomized Controlled Study
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:
• Patient undergoing the first hyperbaric session.
• Understanding and properly carrying out equalization maneuvers
Locations
Other Locations
Brazil
Hospital Felicio Rocho
RECRUITING
Belo Horizonte
Contact Information
Primary
Alan Rodrigues de Almeida Paiva, MD
alanrodriguesmd@gmail.com
+55 31 996869586
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 100
Treatments
Experimental: 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.
No_intervention: Standard treatment
Patients will receive the standard instructions for the hyperbaric chamber without specific guidance on performing equalization maneuvers.
Related Therapeutic Areas
Sponsors
Leads: Hospital Felicio Rocho