GlideScope® vs GlideScope® + aScope® for Managing Difficult Airways. Assessment of a New Procedure for Endotracheal Intubation in Patients With Suspected Difficult Airways
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- first attempt intubation success rate
研究概览
简要总结
The use in a combined way of two systems of intubation (Glidescope + aScope) would condition an increase in the success rate of endotracheal intubation maneuver compared to conventional isolated Glidescope use in patients with clinical criteria of difficult airway.
详细描述
Worldwide, up to 600 patients are estimated to die annually as a result of the complications that occur during tracheal intubation The GlideScope® (videolaryngoscope) is used for endotracheal intubation in patients with difficult airway predictors, in this patients overall success intubation rate is 96%. but success intubation rate at first attempt is only 86%.
Despite this positive rates, due to high comorbidity when intubation fails, both failure rates (inverse of success rate) are impermissible. 14% failure at the first attempt intubation as well as 4% overall intubation failure.
in this study the investigators try to show that new procedure associating aScope® (disposable fiberscope) together with GlideScope® increases the success intubation rate of both ( overall and first attempt).
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
- Single (Participant)
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 programed for general anesthesia with endotracheal intubation required that presents one or both criteria of difficult airway predictors:
- •criteria 1: Arne test >10 (Arne J,1998)
- •criteria 2: Ratio between neck circumference and thyromental distance >
- •(Kim WH, 2011)
排除标准
- •Patients with mouth opening which does not allow the introduction of video laryngoscope.
- •Patients with indication of flexible fiberoptic intubation with awake patient.
研究组 & 干预措施
Glide group
Device: Glidescope® use
干预措施: Glidescope® (Device)
Glide+aScope group
Device: combined use of two airway devices Glidescope® + aScope®
干预措施: aScope® (Device)
Glide+aScope group
Device: combined use of two airway devices Glidescope® + aScope®
干预措施: Glidescope® (Device)
结局指标
主要结局
first attempt intubation success rate
时间窗: through study completion, an average of 1 year.
first attempt intubation success rate
次要结局
- complications related to intubation(30 days postoperative)
- overall intubation success rate(through study completion, an average of 1 year.)
- intubation time (in seconds)(through study completion, an average of 1 year)