Comparation of Efficacy and Safety of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask in Otitis Media Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- successful insert rate
研究概览
简要总结
Objective To investigate the comparative effect of proseal laryngeal mask airway and flexible laryngeal airway mask during otitis media surgery. Methods 200 patients of ASA I or II classification, 18-65 years old, BMI<30 kg/m2 undergoing otitis media surgery are randomly divided into two groups (Group P with proseal laryngeal mask airway and Group F with flexible laryngeal airway mask, respectively). After induction, selecting a appropriate size of LMA to patient,s weight, using the standard index finger-guided technique inserting the LMA, and then the patients were ventilated mechanically. The success rate of inserting laryngeal mask, the intubation time, surgery time and wake time were also recorded. Tidal volume and leakage pressure in patients with supine and lateral positioning were assessed respectively. The scale of fiberoptic bronchoscopy was also recorded to show airway exposure. Related complications such as sore throat, hoarseness, cough, laryngospasm, bloating, nausea and vomiting, soft tissue injury, blood residue after pulling out the LMA were analyzed.Postoperative voice and laryngopharyngeal symptom are also recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of otitis media.
排除标准
- •Problems with the upper airway. Gastric carcinoma. Reflux esophagitis.
结局指标
主要结局
successful insert rate
时间窗: 0 minute after insertion
success rate of inserting laryngeal mask
tidal volume
时间窗: 5 minute afer successful insertion
tidal volume at 15cmH2O in patients with supine and lateral positioning
Number of Participants with cranial nerve injury
时间窗: 1hours after the surgery
Number of Participants with cranial nerve injury
leakage pressure
时间窗: 5 minute afer successful insertion
leakage pressure in patients with supine and lateral positioning
The scale of fiberoptic bronchoscopy
时间窗: 0 minute afer successful insertion
1 = only vocal cords visible; 2 = vocal cords plus posterior epiglottis visible; 3 = vocal cords plus anterior epiglottis visible; and 4 = vocal cords invisible
次要结局
- Number of Participants with hoarseness(1hours after the surgery)
- Number of Participants with laryngospasm(1hours after the surgery)
- Number of Participants with sore throat(1hours after the surgery)
- Number of Participants with cough(1hours after the surgery)
- Number of Participants with soft tissue injury(1hours after the surgery)