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临床试验/NCT02884895
NCT02884895Unknown不适用

Establishing a Definitive Airway: A Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Tube Suction Disposable

Bnai Zion Medical Center0 个研究点目标入组 60 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
Blind tracheal intubation time measure in seconds

研究概览

简要总结

Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal intubation is usually achieved by a direct laryngoscope.It is an effective method but requires experience and skill demanding a long learning time.The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Intubating Laryngeal Tube Suction is a new version of the Laryngeal Tube. The aim of this study is to examine the effectiveness of the the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).

详细描述

Control the airways and respiration are an important part of treatment for a trauma casualty. Tracheal intubation an action that allows the insertion of a tube through the vocal cords and fixation by the balloon inflation is a definitive airway.

Tracheal intubation is usually achieved by a direct laryngoscope. This method is taught both in the training of doctors and paramedics training. Although it is an effective method requires experience and skill demanding a long learning time The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Laryngeal Tube Suction and others similar devices are known as Supraglottic Airway Devices and are inserted blind in the oropharynx and allow a fast oxygenation and ventilation of the patients.

The new generation of these devices allows perform blind intubation directly through a special channel. One of these devices is the Intubating Laryngeal Tube Suction

The aim of this study is to examine the effectiveness of the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).

The hypothesis is that definitive airway obtaining with Intubating Laryngeal Tube Suction will be more success and faster compared to the standard way of direct laryngoscope. If the hypothesis is proven, this research will be very important implications for the management of the airway describing pre-hospital and in particular military scenarios.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •American Society Anesthesiology class I and II

排除标准

  • •Difficult airways
  • •Cervical pathology
  • •Full stomach

研究组 & 干预措施

Intubating laryngeal Tube Suction

Experimental

Intubating laryngeal Tube Suction

干预措施: Intubating Laryngeal Tube Suction (Device)

Direct Laryngoscopy

Active Comparator

Direct Laryngoscopy

干预措施: Direct Laryngoscopy (Device)

结局指标

主要结局

Blind tracheal intubation time measure in seconds

时间窗: 30 seconds

次要结局

  • Easy of insertion measure in numerical scale(30 seconds)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

LUIS.GAITINI

M.D.

Bnai Zion Medical Center

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