Effects of Tongue Root Retractor for Fibroscopic Intubation: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Feasibility of intubation.
研究概览
简要总结
Patients admit to the operation rooms of First Affiliated Hospital of Nanjing Medical University and requiring endotracheal intubation for general anesthesia will be enrolled in this case controlled study.
Patients 1) aged 18 to 70 years; 2) ASA graded I~II class; 3) general anesthesia should be performed under endotracheal intubation, will be included from this study. Patients 1) with organ transplant operations; 2) with thoracic and cardiac vascular surgery; 3) with severe heart or lung disease; 4) BMI over 35kg/m2, will be excluded from this study.
The primary aim is to compare airway clearance for fibreoptic tracheal intubation in each patient position. Secondary outcomes include times to view the vocal cord and carina, the time for tube advancement through the vocal cords, as well as the total time to achieve tracheal intubation.Two anesthesiologists with 5 years of experience in conventional endotracheal intubation and trained for fibreoptic intubation will perform the maneuvers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 to 70 years
- •ASA graded I~II class
- •scheduled for elective surgery requiring orotracheal intubation
排除标准
- •with organ transplant operations
- •with thoracic and cardiac vascular surgery
- •with severe cadiac or pulmonary disease
- •BMI over 35kg/m2
研究组 & 干预措施
Tongue Root Retractor
Patients in this arm will receive fibroscopic endotracheal intubation with tongue root retractors.
干预措施: Tongue Root Retractor (Device)
Conventional Fibroscope
Patients in this arm will receive fibroscopic endotracheal intubation without any other devices.
干预措施: Conventional Fibroscope (Device)
结局指标
主要结局
Feasibility of intubation.
时间窗: From start of intubation to successfully intubated (the endotracheal tube enters the trachea and the cuff is inflated), usually within 3 minutes.
Successs of intubation at different attempts.
次要结局
- Epiglottis level(within 30 seconds after the beginning of fibroscopy)
- Carina time(within 90 seconds)
- Successful Intubation on 1st Attemp(from start of first intubation to end of first intubation attempt)
- Number of attempts for tube advancement(within 120 seconds)