UED-A Videolaryngoscope vs. Glidescope Titanium for Elective Tracheal Intubation: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tracheal intubation rate
研究概览
简要总结
The present randomized clinical trial wants to compare the efficacy and safety of UED-A videolaryngoscope to Glidescope Titanium for routinely tracheal intubation in 60 adults, in terms of successful rate, no. attempts and manoeuvre duration.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients candidates for general anesthesia in elective general surgery
- •Age over 18 years
- •American Society of Anesthesiologists (ASA) physical status I-III.
排除标准
- •Refusal to sign informed consent
- •Paediatric population
- •ASA physical status IV
- •Emergency tracheal intubation
- •Independent Predictors of difficult Videolaryngoscopy (Neck extension < 80°, macroglossia, interincisor distance < 3 cm, anatomical alterations of the neck, cardiac surgery, ear-nose-throat surgery)
结局指标
主要结局
Tracheal intubation rate
时间窗: 30 minutes
Successful tracheal intubation rate
Number of attempts
时间窗: 30 minutes
Number of attempts for a successful tracheal intubation
Time to glottis visualization
时间窗: 15 minutes
Time needed to visualize the glottis from the insertion of the video laryngoscope into the patient mouth
Total time of intubation
时间窗: 15 minutes
Time needed to perform a tracheal intubation from the insertion of the video laryngoscope into the patient mouth
Cormack-Lehane grade
时间窗: 15 minutes
Cormack-Lehane grade observed at videolaryngoscopy Grade 1: Full view of glottis Grade 2: Partial view of glottis Grade 3: Only epiglottis seen, none of glottis seen Grade 4: Neither glottis nor epiglottis seen
次要结局
- Rate of External laryngeal pressure(15 minutes)
- Satisfaction Scale(30 minutes)
- Rate of of post-laryngoscopy side effects(24 hours)
- Rate of Desaturation(15 minutes)
研究者
Giuseppe Pascarella
Principal Investigator
Campus Bio-Medico University