Comparative Study of Video Laryngeal Mask and Endotracheal Intubation in Airway Management in Patients Undergoing Tympanoplasty Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Time to Effective Airway
研究概览
简要总结
The effects of video laryngeal mask and endotracheal intubation on hemodynamic parameters and the development of postoperative respiratory complications in participants scheduled for tympanoplasty will be evaluated.
详细描述
Procedures to be performed under general anesthesia are performed by placing endotracheal intubation and laryngeal mask in the airway. Video Laryngeal Mask (LMA) combines the upper glottic airway device with video laryngoscope tracheal intubation. LMA placement and tracheal intubation can be visualized, LMA position can be continuously monitored during the operation, and adverse events such as LMA displacement can be managed in a timely manner. Studies have shown that video LMA has extraordinary advantages in airway management. This study aimed to compare video LMA and endotracheal intubation in participants who will undergo tympanoplasty surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 18-75
- •Participants with ASA I-II-III
- •Cases with surgery duration of less than two hours
排除标准
- •Participants under 18 years of age
- •Participants who are pregnant
- •Participants with a difficult airway diagnosis
- •Participants with a mouth opening of less than 4 cm
结局指标
主要结局
Time to Effective Airway
时间窗: Baseline
The time to achieve an effective airway was defined as the time between removing the face mask, attaching the airway device, and obtaining 3 square wave capnograph traces with manual ventilation.
次要结局
- Haemodynamic response to insertion of airway device(Baseline, 1st minute, 5th minute)
- Displacement of the SaCoVLM™ video laryngeal mask in head position(Baseline)
- Number of attempts taken for successful placement of airway device(Baseline)
- Incidence of post-operative sore throat(24 hours after surgery)