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临床试验/NCT02382887
NCT02382887已完成不适用

Comparison by Neuromonitoring of Two Techniques of Tracheal Intubation in Patients With Unstable Cervical Spine

University of Lausanne Hospitals1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年3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
发起方
入组人数
40
试验地点
1
主要终点
Neuromonitoring modifications (modifications appearing on the neuromonitoring)

研究概览

简要总结

Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery.

Commonly, the management of the tracheal intubation is performed by a fiberoptic technique.

However, changes in equipment availability and quality may challenge the fiberoptic intubation technique.

The investigators wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.

详细描述

Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery.

Commonly, the management of the tracheal intubation is performed by a fiberoptic technique (historic gold standard technique).

However, changes in equipment availability and quality may challenge the fiberoptic intubation technique.

We wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.

Primary outcomes will be the changes in neurophysiologic responses monitored by a neurophysiologist in 5 specific phases:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •unstable cervical spine due to a cervical vertebra fracture
  • •American Society of Anesthesia classification 1-3
  • •BMI < 30 kg/m2
  • •patients necessitating a general anesthesia for surgery

排除标准

  • •patient refusal
  • •mouth opening < 15mm
  • •patients with known history of previous orotracheal tumor surgery

研究组 & 干预措施

Tracheal intubation with Fiberscopy

Active Comparator

tracheal intubation with a fiberscope

干预措施: tracheal intubation (Procedure)

Tracheal intubation with Fiberscopy

Active Comparator

tracheal intubation with a fiberscope

干预措施: fiberscope (Device)

Tracheal intubation with Airtraq

Experimental

tracheal intubation with an Airtraq

干预措施: tracheal intubation (Procedure)

Tracheal intubation with Airtraq

Experimental

tracheal intubation with an Airtraq

干预措施: Airtraq (Device)

结局指标

主要结局

Neuromonitoring modifications (modifications appearing on the neuromonitoring)

时间窗: 30 seconds

modifications appearing on the neuromonitoring during the 5 different phases

次要结局

  • number of attempts necessary(180 seconds)
  • tracheal inlet view (best view during intubation)(10 seconds)
  • time necessary for tracheal intubation(180 seconds)

研究者

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrick Schoettker,MD PD

MD, PD

University of Lausanne Hospitals

研究点 (1)

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