Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence Reduction of Barotrauma
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient undergoing the first hyperbaric session.
- •Understanding and properly carrying out equalization maneuvers
排除标准
- •Patients who did not understand the equalization maneuvers
- •Patients with specific contraindications to hyperbaric therapy
- •Patients with acute middle ear or tympanic membrane disease
研究组 & 干预措施
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.
干预措施: Maneuver group (Behavioral)
Standard treatment
Patients will receive the standard instructions for the hyperbaric chamber without specific guidance on performing equalization maneuvers.
结局指标
主要结局
Incidence Reduction of Barotrauma
时间窗: Until completion of the study, on average 10 months
Patients performing Eustachian tube opening maneuvers will experience a lower incidence of barotrauma
次要结局
未报告次要终点
研究者
Alan Rodrigues de Almeida Paiva
Principal investigator
Hospital Felicio Rocho