Effectiveness of Autoinflation on the Recurrence of Otitis Media With Effusion After Tympanostomy Tube Extrusion: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Recurrence rate of otitis media with effusion (OME)
研究概览
简要总结
This randomized controlled trial evaluated the effectiveness of autoinflation in preventing recurrence of otitis media with effusion (OME) and reducing the need for reoperation after tympanostomy tube (TT) extrusion in children. Sixty-six pediatric patients with chronic OME underwent TT placement, and 54 were included in the final analysis. After TT extrusion, participants were randomized into two groups: an autoinflation group using a handheld device (Eustachi) for five weeks, and an observation-only group. Patients were followed for two years post-extrusion, with periodic otoscopic and tympanometric assessments.
The autoinflation group showed a lower recurrence rate (19.2%) compared to the observation group (35.7%), although this difference was not statistically significant. However, the reoperation rate was significantly lower in the autoinflation group (7.7% vs. 28.6%). Tympanometric findings suggested more stable middle ear pressure in the autoinflation group. These results indicate that autoinflation is a safe, feasible, and non-invasive method that may support eustachian tube function and reduce the need for repeat TT placement in children following TT extrusion.
详细描述
Otitis media with effusion (OME) is a prevalent pediatric condition that may lead to hearing loss and developmental delay. Tympanostomy tube (TT) placement is the standard treatment for persistent OME but does not address the underlying cause, and recurrence is common after TT extrusion. This study investigated whether autoinflation after TT extrusion could reduce OME recurrence and the need for reoperation.
In this prospective randomized controlled trial, 66 children aged 3 to 8 years with chronic OME were enrolled at a tertiary hospital. All underwent TT placement under general anesthesia and were followed bi-monthly in the outpatient clinic. After TT extrusion, 54 patients were randomized to either the autoinflation group (n = 26) or the observation group (n = 28). The autoinflation group used the Eustachi device twice daily for five weeks, with instructions provided to children and caregivers. Patients with adenoid hypertrophy, craniofacial anomalies, active otologic disease, or severe systemic disease were excluded.
Outcome measures included OME recurrence and TT reoperation rates over two years, evaluated through otoscopy and tympanometry. The recurrence rate was lower in the autoinflation group (19.2%) than in the observation group (35.7%), though the difference was not statistically significant. However, the reoperation rate was significantly lower in the autoinflation group (7.7%) compared to the observation group (28.6%, p = 0.048). Tympanometry results also showed stable middle ear pressure in the autoinflation group, whereas the observation group experienced a decline in type A tympanograms and an increase in type C patterns over time.
These findings suggest that autoinflation may promote functional rehabilitation of the eustachian tube and maintain middle ear ventilation after TT extrusion. The intervention was well tolerated and feasible in a home setting with caregiver supervision. While autoinflation should not replace TT placement in persistent OME, it may serve as a valuable non-invasive strategy to reduce the risk of recurrence and the need for repeat surgery. Limitations include sample size and lack of quantitative compliance data, warranting future multicenter studies for validation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 to 8 years
- •Clinical diagnosis of chronic otitis media with effusion (OME)
- •Underwent tympanostomy tube (TT) placement for persistent OME lasting more than 3 months
- •Capable of performing autoinflation, as assessed by the physician
- •Caregiver willing to provide informed consent and assist with at-home device use
排除标准
- •Presence of adenoid hypertrophy or tonsillar hypertrophy
- •History of craniofacial anomalies (e.g., cleft palate)
- •Current otologic disease such as otorrhea or tympanic membrane perforation
- •Acute otitis media or signs of active inflammation at enrollment
- •Underlying severe systemic disease or immunodeficiency
- •Inability or refusal to follow autoinflation protocol
研究组 & 干预措施
Autoinflation
Participants perform autoinflation using the Eustachi device twice daily for 5 weeks after TT extrusion.
干预措施: Eustachi (Device)
Observation
Participants are followed without autoinflation after TT extrusion (standard observation only).
结局指标
主要结局
Recurrence rate of otitis media with effusion (OME)
时间窗: Up to 24 months after tympanostomy tube extrusion
The proportion of patients with a recurrence of OME in the affected ear(s), diagnosed by otoscopy and/or tympanometry, during a 2-year follow-up period after tympanostomy tube extrusion.
次要结局
未报告次要终点