Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without Stylet: Prospective Non-inferiority Comparison
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 246
- 主要终点
- First-attempt success rate of tracheal intubation
研究概览
简要总结
Patients are randomly assigned to either the oral RAE tube group (Group O) or the reinforced tube group (Group R). In both groups, tracheal intubation is performed using a videolaryngoscope without a stylet, and the first-attempt success rate is compared. Upon emergence from anesthesia and removal of the endotracheal tube, the degree of subglottic injury is assessed and compared between the groups. In addition, postoperative sore throat and hoarseness are evaluated and compared at 1 hour and 24 hours after surgery.
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 surgery under general anesthesia
排除标准
- •Refusal to participate in the study
- •History of gastroesophageal reflux disease
- •Inadequate preoperative fasting
- •Congenital or acquired upper airway abnormalities (e.g., tumors, polyps, trauma, abscesses, inflammation, foreign bodies)
- •History of upper airway surgery
- •High risk of aspiration or bleeding tendency
- •Presence of severely loose teeth
结局指标
主要结局
First-attempt success rate of tracheal intubation
时间窗: Immediately after induction of anesthesia
The proportion of patients in whom tracheal intubation is successfully completed on the first attempt using a videolaryngoscope without a stylet, comparing the oral RAE tube group with the reinforced tube group.
次要结局
- Oxygen saturation(Periprocedural (immediately before and immediately after tracheal intubation))
- Incidence and grade of subglottic airway injury(Immediately after completion of surgery (at extubation))
- Postoperative sore throat score(1 hour and 24 hours postoperatively)
- Incidence of postoperative hoarseness(1 hour and 24 hours postoperatively)
- Cormack-Lehane grade and POGO score(Periprocedural (during tracheal intubation))
- Mean blood pressure(Periprocedural (immediately before and immediately after tracheal intubation))
- Heart rate(Periprocedural (immediately before and immediately after tracheal intubation))
- Bispectral index(Periprocedural (immediately before and immediately after tracheal intubation))