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临床试验/NCT01814176
NCT01814176已完成不适用

Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope in Patients With at Least One Difficult Intubation Risk Factor

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Peak forces during intubation

研究概览

简要总结

During Anesthesia many patients require that a breathing be inserted into their windpipe. This is usually achieved using a direct laryngoscope, consisting of a retraction blade with a light near its end. When achieving a direct line-of-sight to the windpipe is difficult, more force is often applied, resulting in greater patient stress. A GlideScope video laryngoscope uses a camera and light source to see the windpipe. This enables the user to see objects that may not be in the direct line-of-sight. This likely results in less force being required, reducing patient stress. Because such stresses are often confounded by patient variables, we are comparing the forces required by the direct and video laryngoscopes on patients with at least one risk factor for difficulty, by directly measuring these with special sensors attached to the laryngoscope blades.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

  • •age > 18years
  • •elective surgery
  • •single lumen endotracheal intubation required
  • •signed informed consent
  • •one risk factor for a difficult laryngoscopy ( Mallampati score >3, inter-incisor gap < 3.5cm, thyromental distance < 6.5cm, sternomental distance < 12.5cm, reduced neck extension and flexion)

排除标准

  • •lack of patient consent
  • •anesthesiologist declines to consent
  • •contraindication to neuromuscular blockade
  • •rapid sequence intubation
  • •previous failed intubation
  • •other method of intubation indicated eg fiberoptic intubation, awake tracheostomy
  • •symptomatic gastro-esophageal reflux
  • •cervical spine instability
  • •unstable hypertension and symptomatic coronary artery disease
  • •cerebrovascular disease or raised intracranial pressure
  • •oral/pharyngeal/laryngeal carcinoma
  • •loose teeth/poor dentition

研究组 & 干预措施

Macintosh Direct Laryngoscope

Active Comparator

2 main forces - a 'lifting' force to elevate the structures not in the line of sight and a force exerted by the user's wrist to counterbalance the torque effect of the tongue tissues on the blade

干预措施: Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope (Device)

GlideScope Video Laryngoscope

Active Comparator

The GlideScope has a 60º angulation anteriorly at the distal portion of the blade, allowing an anterior view of the larynx.

干预措施: Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope (Device)

结局指标

主要结局

Peak forces during intubation

时间窗: Intraoperatively

Peak forces generated during the laryngoscopy and intubation process using both laryngoscopes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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