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临床试验/NCT04618926
NCT04618926Unknown不适用

A Prospective Randomized Study Comparing Fiberoptic Bronchoscope Endotracheal Intubation Between the Intubating Laryngeal Tube Suction and the LMA Protector

Bnai Zion Medical Center0 个研究点目标入组 80 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
主要终点
time of success fiberoptic endotracheal intubation

研究概览

简要总结

Securing the airway is a pivotal skill for anesthesiologists and emergency care providers. Endotracheal intubation (ETI) is considered the gold standard for securing the airway.

When ETI via laryngoscopy has failed, the use of a supraglottic airway device (SGAD) has been recommended. The intubating Laryngeal Tube Suction-Disposable and the LMA Protector are a new step in the evolution of supraglottic airways. Both SGADs are enable to ventilation and oxygenation, but the ventilation channel allow the insertion of an endotracheal tube and the use of fiberoptic bronchoscope. The aim of this study is to compare the time of fiberoptic intubation through the intubating Laryngeal Tube Suction Disposable and the LMA Protector in adult patients.

详细描述

Detailed Description: Securing the airway is a pivotal skill for anesthesiologist and emergency providers. Endotracheal intubation (ETI) is considered the gold standard for securing the airway. Induction time during anesthesia may sometimes present unexpected difficulties during ETI.

When ETI via laryngoscopy has failed, the use of a supraglottic airway device (SGAD) has been recommended. Previous studies suggested that compare intubation with laryngoscope, SGADs enables rapid and effective airway control. Improved second generation SGADs enable ventilation and oxygenation, but also include a second channel that separates the trachea from the esophagus preventing aspiration. According with the results of the Fourth National Audit Project of the Royal College of Anesthetist will bets and the Difficult Airway Society, the second generation SGADs should be uses instead the first generation.

Some of the second generations of SGADs have a ventilation channel that allow the insertion of an endotracheal tube.

Two of these devices recently introduced in the market are the intubating Laryngeal Tube Suction Disposable (iLTS-D) and the Laryngeal Mask Airway Protector [5, 6] The intubating Laryngeal Tube Suction- Disposable (iLTS-D) (VBM, Germany) is a new updated version of the Laryngeal Tube-Suction Disposable (LTS-D). [5] It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube (ETT) No 7.5 mm. for fiberoptic 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 device is latex free, made of PVC, and like the original laryngeal tube (LT), can be inserted blindly.

The iLTS-D comes in one size. According to the depth of insertion, the device will be equivalent to size 4 for patients 175 to 190 cm tall, or size 5 for patients taller than 190 cm.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

time of success fiberoptic endotracheal intubation

时间窗: 60 seconds

seconds

次要结局

未报告次要终点

研究者

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

LUIS.GAITINI

Associate Clinical Professor of Anesthesiology

Bnai Zion Medical Center

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