Serial Eustachian tube equalization maneuvers during hyperbaric oxygen therapy
Official title: Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions: A Randomized Controlled Study
Run by Hospital Felicio Rocho · NCT06408363 · Data updated 2026-11-12
This will test whether doing a series of Eustachian tube equalization maneuvers during the first hyperbaric oxygen session can prevent middle ear barotrauma in patients who can perform the maneuvers.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hospital Felicio Rocho Academic / other |
| Locations | 1 site (Belo Horizonte, Minas Gerais) |
| Status | Recruiting |
| Started | May 1, 2023 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT06408363 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults undergoing their first hyperbaric oxygen session who understand and can correctly perform Eustachian tube equalization maneuvers and have no acute middle ear disease.
✕Probably not a fit
Patients with acute middle ear or tympanic membrane disease, those who cannot perform or understand equalization maneuvers, or those with contraindications to hyperbaric therapy are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional protocol enrolls patients undergoing their first hyperbaric oxygen session who can learn and perform Eustachian tube equalization maneuvers. Participants are instructed to perform serial tubal-opening maneuvers during chamber pressurization to maintain middle ear pressure equilibrium. The main outcome is occurrence and severity of middle ear barotrauma, including otalgia and tympanic membrane changes up to perforation. Patients with acute middle ear disease or contraindications to hyperbaric therapy are excluded and the intervention is delivered at a single center in Belo Horizonte, Brazil.
Why it matters
Potential benefit: If successful, the maneuver protocol could reduce the rate of middle ear barotrauma and improve tolerance and adherence to hyperbaric oxygen therapy.
How similar studies have gone: Some prior work in diving and aviation contexts suggests Eustachian tube maneuvers can reduce barotrauma, but evidence specifically in hyperbaric oxygen sessions is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, Brazil Recruiting
Study contacts
- Study coordinator: Alan Rodrigues de Almeida Paiva, MD
- Email: alanrodriguesmd@gmail.com
- Phone: +55 31 996869586
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.