Barotrauma;EarNCT06408363
Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions
A study testing Maneuver group in people with Barotrauma;Ear and Tympanum; Perforation, run by Hospital Felicio Rocho at 1 site in Brazil.
Trial summary
Middle ear barotrauma represents the predominant complication associated with hyperbaric oxygen therapy, manifesting symptoms ranging from otalgia to tympanic membrane perforation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Barotrauma;Ear, Tympanum; Perforation
- What is being tested?
- Maneuver group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient undergoing the first hyperbaric session.
- Understanding and properly carrying out equalization maneuvers
Who cannot join
- Patients who did not understand the equalization maneuvers
- Patients with specific contraindications to hyperbaric therapy
- Patients with acute middle ear or tympanic membrane disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, 30110-934
Alan Rodrigues de Almeida Paiva, MD, +55 31 996869586, alanrodriguesmd@gmail.com
About this study
Official title: 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.
- Conditions
- Barotrauma;Ear, Tympanum; Perforation
- Being tested
- Maneuver group
- Keywords
- Barotrauma, Tympanic Membrane Perforation, Eustachian Tube, Hyperbaric Oxygenation
- Medical subject headings
- Tympanic Membrane Perforation, Barotrauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maneuver groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Maneuver group | Experimental | 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. Receives: Behavioral: Maneuver group |
| Standard treatment | No intervention | Patients will receive the standard instructions for the hyperbaric chamber without specific guidance on performing equalization maneuvers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Reduction of Barotrauma
Patients performing Eustachian tube opening maneuvers will experience a lower incidence of barotrauma
Measured: Until completion of the study, on average 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 May 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barotrauma;EarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Felicio Rocho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Rodrigues de Almeida Paiva, Hospital Felicio Rocho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408363
- Sponsor's protocol ID
- 74381223500005125
- Status last verified
- Jun 2025
- First submitted
- 18 Apr 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06408363
- Acronym / sponsor ID
- 74381223500005125
- Conditions
- Barotrauma;Ear, Tympanum; Perforation
- Keywords
- Barotrauma, Tympanic Membrane Perforation, Eustachian Tube, Hyperbaric Oxygenation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Felicio RochoUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maneuver group | Experimental | Behavioral: Maneuver groupPatients 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. |
| Standard treatment | No intervention | –Patients will receive the standard instructions for the hyperbaric chamber without specific guidance on performing equalization maneuvers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergoing the first hyperbaric session.
- Understanding and properly carrying out equalization maneuvers
Key exclusion criteria (3 listed)
- Patients who did not understand the equalization maneuvers
- Patients with specific contraindications to hyperbaric therapy
- Patients with acute middle ear or tympanic membrane disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maneuver groupThese 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. | Behavioural | Maneuver group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maneuver group in people with Barotrauma;Ear and Tympanum; Perforation, run by Hospital Felicio Rocho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alan Rodrigues de Almeida Paiva, MD (+55 31 996869586, alanrodriguesmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Reduction of Barotrauma (time frame: Until completion of the study, on average 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.