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临床试验/NCT02884843
NCT02884843Unknown不适用

A Comparative Randomized Prospective Study Between the New Intubating Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Blind and Fibreoptic-guided Intubation

Bnai Zion Medical Center0 个研究点目标入组 60 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Time of blind intubation measure in seconds

研究概览

简要总结

The study compares the intubating Laryngeal Tube Suction (iLTS-D) with the Ambu®AuraGain™ in blind and fibreoptic endotracheal intubation.

The current randomized study is designed to assess the success rate of blind and fibreoptic endotracheal intubation using i-LTS-D, in comparison with the Air-Q, i-gel® and Ambu®AuraGain™ in an airway simulator. The investigators hypothesize that the iLTS-D and the Supreme Laryngeal Mask Airway will similarly perform during spontaneous ventilation despite differences in their structural design.

详细描述

The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik, Sulz, Germany) is a new updated version of the Laryngeal Tube-Suction Disposable (LTS-D).

It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube (ETT) either blindly or with fibreoptic guidance. Similarly to the LTS-D, the iLTS-D also has a separate channel for gastric tubes placement up to a size of 18 Fr.

The current randomized study was designed to assess the success rate of blind and fibreoptic endotracheal intubation using iLTS-D, in comparison with the Ambu® AuraGain™ in adult patients under general anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
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

入选标准

  • American Society Anesthesiology I and II

排除标准

  • Difficult intubation, cervical pathology

结局指标

主要结局

Time of blind intubation measure in seconds

时间窗: 30 seconds

次要结局

  • Time of Fiberoptic intubation measure in seconds(60 seconds)

研究者

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

LUIS.GAITINI

Medical Doctor

Bnai Zion Medical Center

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