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临床试验/NCT02878005
NCT02878005Unknown不适用

A Prospective and Randomized Study Comparing the New Intubating Laryngeal Tube Suction and the Ambu AuraGain in Adult Patients

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 to performe blind intubation measure in second

研究概览

简要总结

The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube either blindly or with fiberoptic guidance.This study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.

详细描述

The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik GmbH, 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 fiberoptic guidance. Similarly As in to the LTS-D, the iLTS-D also has a separate channel for the purpose of placement of gastric tubes placement up to a size of 18 Fr.

The iLTS-D comes in one size. According to the depth of insertion, this device is equivalent to size 4 for patients 175patients 175 to 190 cm tall, or size 5 for patients taller than 190 cm. The iLTS-D is provided by the manufacturer with a compatible 7.5mm ETT and with a plastic stabilizer for removal of the device.

The current randomized study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and 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
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

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 to performe blind intubation measure in second

时间窗: 30 seconds

次要结局

  • Time to performe fiberoptic intubation in second(60 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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