NCT02088801已完成不适用
Phase 2 Study of Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- first attempt intubation success rate
研究概览
简要总结
In this second phase of the multicenter study the investigators are going to evaluate the use of three different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these three videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As the gold standard, a standard Macintosh blade is being used for comparison.
The study consists of 4 arms. Each arm includes 120 patients, sums up to a total of 480 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •elective surgery with general anesthesia requiring intubation
- •>18 years old
- •ASA I-III
排除标准
- •known or presumed difficult airway
- •risk of pulmonary aspiration
- •refusing to participate
结局指标
主要结局
first attempt intubation success rate
时间窗: intraoperative
次要结局
- side effects(1h and 1day after intubation)
研究者
Lorenz Theiler
Principle investigator
Insel Gruppe AG, University Hospital Bern
研究点 (2)
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