Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions

May 6, 2024 updated by: Alan Rodrigues de Almeida Paiva, Hospital Felicio Rocho

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-934
        • Hospital Felicio Rocho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
No Intervention: Standard treatment
Patients will receive the standard instructions for the hyperbaric chamber without specific guidance on performing equalization maneuvers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until completion of the study, on average 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Felicio Rocho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 74381223500005125

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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