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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Standard treatment | No Intervention | Patients will receive the standard instructions for the hyperbaric chamber without specific guidance on performing equalization maneuvers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maneuver group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Reduction of Barotrauma | Patients performing Eustachian tube opening maneuvers will experience a lower incidence of barotrauma | Until completion of the study, on average 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alan Rodrigues de Almeida Paiva, MD | Contact | +55 31 996869586 | alanrodriguesmd@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Felicio Rocho | Recruiting | Belo Horizonte | Minas Gerais | 30110-934 | Brazil |
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| ID | Term |
|---|---|
| D018058 | Tympanic Membrane Perforation |
| D001469 | Barotrauma |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
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