Safety and Efficacy Assessment of a New Tracheal Intubation Device Cleverscope. Success Rate of Cleverscope in Patients With Suspected Difficult Airway.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate)
研究概览
简要总结
Cleverscope is a new medical device that transform a laryngoscope into a videolaryngoscope. previous its commercialization we evaluate its safety and efficacy.
详细描述
the investigators develope two part study. part I: the investigators collect data of 50 patients prospectively programed for general anesthesia and tracheal intubation without predictors of difficult airways. this patients were intubated with cleverscope, the investigators register best cormack-lehane (glottic vision) obtained with Cleverscope and best cormack obtained with direct laryngoscopy. the investigators register intubation succes rate and any complications during its use and after extubation.
part II: after confirm safety and efficacy in patients without difficult airways (part I) the investigators use Cleverscope for the same pourpose on difficult airways patients. collecting same data . the investigators compare cormack-lehane in this patients with Cleverscope and commercial Videolaryngoscope C-MAC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •part 1: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation without predictors of difficult intubation :
- •Arne Test < 10
- •cervical circunference / tyromental distance <
- •part 2: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation with predictors of difficult intubation :
- •Arne Test > 10
- •cervical circunference / tyromental distance > 4.
排除标准
- •no mouth openning >2cm
- •required use of awake fiberscope por tracheal intubation
结局指标
主要结局
Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate)
时间窗: intraoperative
degree of glotis visualization
次要结局
- First attempt intubation success rate(intraoperative)
- complications rate(intraoperative)
- time to success(intraoperative)
- overall success intubation rate with same device(intraoperative)
研究者
Lucas Rovira
Principal Investigator
Hospital General Universitario de Valencia