First Attempt Success in Tracheal Intubation Through Supraglottic Airway Devices Without Fiberoptic Guidance: Conventional vs. Video-assisted Supraglottic Airway Devices, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 204
- 主要终点
- First-attempt success rate of tracheal intubation through the supraglottic airway device
研究概览
简要总结
This randomized controlled trial aims to compare the first-attempt success rate of tracheal intubation through supraglottic airway devices using a conventional intubating supraglottic airway device versus a video-assisted supraglottic airway device without fiberoptic guidance in adult patients undergoing elective surgery under general anesthesia. A total of 204 participants will be randomly assigned to one of the two groups. The primary outcome is the first-attempt success rate of tracheal intubation through the supraglottic airway device. Secondary outcomes include intubation time, number of intubation attempts, overall intubation success, hemodynamic changes, airway-related complications, postoperative sore throat and hoarseness, and adverse events. The results of this study may help identify a safe and effective airway management strategy when fiberoptic bronchoscopy is unavailable.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older.
- •Scheduled to undergo elective surgery under general anesthesia requiring tracheal intubation.
排除标准
- •Refusal or inability to provide informed consent.
- •Emergency surgery.
- •History of gastroesophageal reflux disease.
- •Previous surgery or radiotherapy involving the upper airway.
- •Severely loose teeth.
- •Any condition considered by the investigator to make study participation inappropriate.
结局指标
主要结局
First-attempt success rate of tracheal intubation through the supraglottic airway device
时间窗: At the time of tracheal intubation during induction of general anesthesia
The proportion of participants in whom tracheal intubation through the assigned supraglottic airway device is successfully achieved on the first attempt without fiberoptic guidance.
次要结局
- Intubation time(During induction of general anesthesia)
- Number of intubation attempts(During induction of general anesthesia)
- Overall intubation success rate(During induction of general anesthesia)
- Postoperative sore throat(1 hour and 24 hours after surgery)
- Postoperative hoarseness(1 hour and 24 hours after surgery)
研究者
Shin Kyung Won, MD
Clinical Assistant Professor
Seoul National University Hospital