The Effect of Fiberoptic Bronchoscopy Examination on Supraglottic Airway Devices Position in Patients Undergoing Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- glottic visualization grades by fiberoptic exam assessment
研究概览
简要总结
A comparison of SaCo VLMTM video laryngeal mask airway with the I-gel supraglottic airway during airway management in patients undergoing elective surgery.
详细描述
The position of the supraglottic airway is checked using a fiberoptic endoscope: The bronchoscope is placed at the opening of the laryngeal mask, and assessed using the following grading system: Grade 1: Vocal cords not visible. Grade 2: Vocal cords and anterior epiglottis visible. Grade 3: Vocal cords and posterior epiglottis visible. Grade 4: Only vocal cords visible.
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
- None
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
- •ASA classification I~III, age 18~65 y/o, BMI 18~30kg/m2, elective surgery, surgery duration < 2 hours, supine position, general anesthesia with laryngeal mask airway insertion
排除标准
- •Smoking, betel nuts use, any known anatomical variation or disease of facial or airway structure, anticipated difficult airway, limited mouth opening distance or neck motility, loosening teeth, gastroesophageal reflux history, ongoing upper airway infection or inflammation symptoms
研究组 & 干预措施
Third-generation SADs (SaCoVLM)
The third-generation SADs (i.e. SaCoVLM™) combines video system and laryngeal mask with gastric drain.
干预措施: a native video image system (Device)
Second-generation SADs (I-gel™)
The second-generation SADs (i.e. I-gel™) with a gastric drain conduit have designed to reduce the risk of gastric reflux and aspiration.
干预措施: a native video image system (Device)
Second-generation SADs (I-gel™)
The second-generation SADs (i.e. I-gel™) with a gastric drain conduit have designed to reduce the risk of gastric reflux and aspiration.
干预措施: Fiberoptic bronchoscope (Device)
结局指标
主要结局
glottic visualization grades by fiberoptic exam assessment
时间窗: From anesthesia induction to the end of surgery
Grade 1: vocal cords were not visualizedGrade 2: vocal cords and anterior epiglottis were visualizedGrade 3: vocal cords and posterior epiglottis were visualized Grade 4: vocal cords only were visualized
次要结局
- Intra-operative effectiveness(From anesthesia induction to the end of surgery)
研究者
KMUHIRB-F(I)-20240331
Associate professor
Kaohsiung Medical University Chung-Ho Memorial Hospital