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临床试验/NCT02614924
NCT02614924已完成不适用

Comparison of Flexible Fibreoptic Scope With Pentax AWS Videolaryngoscope for Ease of Intubation During Awake Intubation

University Hospitals Coventry and Warwickshire NHS Trust0 个研究点目标入组 40 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Total Time Taken to Complete the Procedure of Awake Intubation

研究概览

简要总结

The purpose of this study is to identify whether Pentax Airway Scope (AWS) videolaryngoscope would be a more effective device compared to flexible fibreoptic scope (FOS) for awake intubation in a difficult airway.

详细描述

Background:

The incidence of difficult tracheal intubation during routine anaesthesia in general population is around 3-18% although it varies [1]. Awake intubation is considered in situations such as in patients with a known or suspected difficult airway, upper airway obstruction. Awake intubation under local anaesthesia and sedation also indicated cervical spine disease in view of minimising movement of cervical spine [2]. Any technique tracheal intubation under general anaesthesia involves some degree of movement at cervical spine. Direct laryngoscopy and tracheal intubation in under general anaesthesia is usually achieved by flexion of lower cervical spine and extension at atlanto-occipital joint [3]. Difficulties or failure in airway management is still an important factor in morbidity and mortality related to anaesthesia.

In recent years videolaryngoscopes have been used as an alternative to traditional fibreoptic scope in the management of difficult airway [4,7,8]. Over last 2 years in our institution the investigators have used Pentax AWS videolaryngoscope for awake intubation in patients presenting for surgery with cervical spine disease [9, 10].

However there has not been any study comparing flexible fibreoptic scope with video laryngoscopes in the management of difficult airway in awake patients. The proposed benefits of Pentax AWS (Airway scope) over a flexible fibreoptic scope include ease of setting up the device, less complexity of the skill, therefore easy to learn the skill and availability of disposable devices minimising the need for cleaning and disinfecting the device.

Pentax AWS with PBlade videolaryngoscope has a unique target symbol displayed on the monitor, which highlights the intended path of the endotracheal tube. The Pentax PBlade is a single patient use device that minimizes the risk of infection.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with cervical spine disease presenting for cervical spinal surgery and requiring awake intubation under local anaesthesia and conscious sedation.
  • Patients with anticipated difficult airway include those with Mallampati class 3 and above, other signs such as limited neck movement and limited jaw protrusion will be include in the study

排除标准

  • Children below 18 years of age, pregnant mothers and patients presenting with airway pathology will be excluded.

结局指标

主要结局

Total Time Taken to Complete the Procedure of Awake Intubation

时间窗: up to 20 minutes

次要结局

  • Intubation Time(up to 10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

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