The Evaluation of Eustachian Tube Function and Its Influencing Factors After Snoring in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Tympanogram
研究概览
简要总结
This study aims to evaluate and screen out the factors related to the improvement of eustachian tube function after adenoidectomy and/or tonsillectomy, so as to guide the treatment of children's eustachian tube function before and after operation, and provide the treatment direction and methods for diseases related to eustachian tube dysfunction for people with adenoid hypertrophy and/or tonsil hypertrophy complicated with ETD.
详细描述
This study aims to analyze the changes of eustachian tube function in children with snoring and eustachian tube dysfunction before and after snoring surgery, and to evaluate and screen out the related factors related to the improvement of eustachian tube function after snoring surgery. The patients who were admitted to hospital and diagnosed as children's snoring complicated with diseases related to eustachian tube dysfunction and planned to undergo surgical treatment for children's snoring should be included, and relevant examinations should be improved, including preoperative nasopharyngoscope, otoscope, acoustic immittance and pure tone audiometry. After snoring operation, he returned to the hospital at 6, 12 and 24 weeks after operation for reexamination of nasopharyngoscope, otoscope, acoustic immittance, pure tone audiometry and TMM. The patients were assessed with ETDQ-7 score, ETS-7 score and VAS score by self-administered questionnaire. The effective risk-related factors were screened out by single factor and multi-factor Logistics regression analysis. To guide the treatment of children's eustachian tube function before and after operation, and to provide the treatment direction and methods for children's snoring diseases complicated with ETD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •① Age 3-14 years old.
- •② Patients diagnosed as snoring or adenoid hypertrophy in children, tonsil hypertrophy and chronic tonsillitis who are to be treated by adenoidectomy or tonsillectomy or tonsillectomy;
- •③ Conform to
- •Symptoms: snoring during sleep, breathing with mouth open, some with apnea, restless sleep, and a few children with hearing loss.
- •Fiberoptic nasopharyngoscopy showed adenoids and/or tonsil hypertrophy.
- •No family history of deafness, no history of ototoxic drugs.
- •No external ear and maxillofacial deformity.
- •The tympanic pressure curve is "C" or "B".
- •No suppurative medium.
- •Auricular inflammation and tympanic membrane perforation; Adhesive otitis media, cholesteatoma of middle ear.
- •④ Patients' families cooperated well.
- •⑤ The patient's guardian volunteered to participate in this study and signed the informed consent form.
排除标准
- •Middle ear catheterization or puncture was performed at the same time;
- •Eustachian atresia or cleft lip and palate; There are craniofacial abnormalities or neuromuscular diseases;
- •Benign and malignant tumors of nose or nasopharynx;
- •Other middle ear diseases (suppurative otitis media, tympanic membrane perforation; Adhesive otitis media, middle ear cholesteatoma, etc.); ⑤ Those who can't cooperate; ⑥ Previous tonsil and adenoid surgery; ⑦ Upper respiratory tract infection in recent two weeks; ⑧ Any other circumstances that researchers think should be excluded from this study;
结局指标
主要结局
Tympanogram
时间窗: 6 weeks after operation
Acoustic immittance test
次要结局
- Eustachian tube inflammation(6 weeks after operation)
- EDTQ-7 symptom score(6 weeks after operation)