Fiberoptic Intubation With Simultaneous Video-laryngoscopy Versus Through a Supraglottic Airway in Children With a Difficult Airway: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- first attempt intubation success rate
研究概览
简要总结
To compare two hybrid techniques, flexible bronchoscopy-guided intubation with a video laryngoscope and flexible bronchoscopy-guided intubation with a laryngeal mask, that have recently shown promise as a way to increase first-attempt success rates and reduce complications in children with anticipated difficult intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Month 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children from 1 month of age to less than 12 years of age who are expected to have a difficult intubation when undergoing routine surgery under general anesthesia.
排除标准
- •When there is limited mouth opening, making it difficult to insert supraglottic airway ② The patient or their parents do not agree to participate in the study. ③ Other cases deemed unsuitable by the researcher
结局指标
主要结局
first attempt intubation success rate
时间窗: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
The success rate of a healthcare provider's first attempt to insert a tube into a patient's airway. Intubation is defined as successful if the tube is inserted and capnography is first seen. If the fiberoptic bronchoscope comes out of the mouth, it is a failure.
次要结局
- total intubation time (seconds)(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
- intubation-related complication(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
- Number of intubation attempts(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
- successful tracheal intubation (Yes or No)(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
- successful tracheal intubation with the allocated method(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
- The degree of vocal cord exposure assessed with a flexible bronchoscope. (Modified Cormack-Lehane grade, I/II/III/IV)(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
- Nadir oxygen saturation during intubation (SpO2 value, %)(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
- Oxygen reserve index during intubation (ORi™, Rainbow Signal Extraction Technology)(from induction of anesthesia to 1 minutes after intubation, about 10 minutes.)
研究者
Eun-hee Kim
Clinical Associate Professor
Seoul National University Hospital