Serial Eustachian tube equalization maneuvers during hyperbaric oxygen therapy
Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions: A Randomized Controlled Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Hospital Felicio Rocho Academic / other |
| Locations | 1 site (Belo Horizonte, Minas Gerais) |
| Trial ID | NCT06408363 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Some prior work in diving and aviation contexts suggests Eustachian tube maneuvers can reduce barotrauma, but evidence specifically in hyperbaric oxygen sessions is limited.
Eligibility criteria
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 this trial is running
Belo Horizonte, Minas Gerais
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.