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临床试验/NCT01467739
NCT01467739已完成不适用

Evaluation of the Ambu ® aScope® for Tracheal Intubation During Cervical Spine Immobilization With a Cervical Collar, in Comparison With a Conventional Reusable Fiberscope.

University of Lausanne Hospitals2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Effectiveness of the Ambu ® aScope® for tracheal intubation in difficult airways.

研究概览

简要总结

The purpose of this study is to evaluate a disposable fiberscope (Ambu ® aScope®) for tracheal intubation in difficult airways due to cervical immobilization by a cervical collar, and compare it to a conventional reusable fiberscope.

详细描述

Any general anesthesia requiring tracheal intubation for controlled ventilation includes the likelihood of intubation failure and, in case of difficult or impossible mask ventilation, can be life-threatening. In patients with diagnosed or suspected disease of the cervical spine, airway control can be tricky. Indeed, the cervical collar used to secure the cervical spine makes direct laryngoscopy impossible. In elective surgery, the most commonly used technique is fiberoptic intubation, achievable without removing of the cervical collar.

A new disposable fiberscope was recently developed by Ambu ®: the aScope®. It consists of a disposable flexible fiberscopic device, whose distal end is fitted with a camera that can be directed. This device is connected to a separate reusable LCD display. The aScope® is used as a conventional flexible fiberscope to guide the instrumentation of the airway.

With the exception of case reports, all studies of this device in difficult conditions were performed on mannequins.

The investigators propose to assess and validate this device on real patients with difficult airways caused by a rigid cervical collar and compare intubation conditions and time to the gold standard technique, the classical reusable fiberscope.

Induction of general anesthesia is performed by the anesthesiologist responsible for the patient, according to the standards in the anesthesiology department.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Patients older than 16 years
  • BMI < 35 kg/m2
  • Surgery requiring general anesthesia with intubation of the trachea

排除标准

  • Emergency operation
  • Patient ASA 3 or more
  • BMI above 35 kg/m2
  • History of difficult airways
  • History of surgery or radiotherapy in head and neck
  • Presence of gastro esophageal reflux

结局指标

主要结局

Effectiveness of the Ambu ® aScope® for tracheal intubation in difficult airways.

Time to reach the carina and Time to obtain an end tidal CO2 curve by aScope in comparison to conventional reusable fiberscope.

次要结局

未报告次要终点

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

University of Lausanne Hospitals

研究点 (2)

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