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临床试验/NCT05347680
NCT05347680已完成不适用

A Prospective and Randomized Study Comparing Fiberoptic Intubation Through the New Intubating Laryngeal Tube Suction and the Ambu AuraGain in Adult Patients Secondary IDs:

Bnai Zion Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Time to perform fiberoptic intubation through supraglottic device 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 with fiberoptic guidance. This study was designed to assess the Time 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 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 with fiberoptic guidance. This study was designed to assess the Time of fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.

Detailed Description: 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) 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 height 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 7.5 mm ETT and with a plastic stabilizer for removal of the device.

The current randomized study was designed to assess the success rate 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 (Participant)

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
  • pregnancy

研究组 & 干预措施

intubating laryngeal Tube Suction

Active Comparator

Fiberoptic Intubation through intubating laryngeal Tube Suction

干预措施: Intubating Laryngeal Tube Suction (Device)

Ambu AuraGain Laryngeal Mask

Active Comparator

Fiberoptic Intubation through Ambu AuraGain Laryngeal Mask

干预措施: Ambu AuraGain Laryngeal Mask (Device)

结局指标

主要结局

Time to perform fiberoptic intubation through supraglottic device in second

时间窗: 120 seconds

Time to perform endotracheal fiberoptic intubation through supraglottic device in second

次要结局

  • Success to obtain fiberoptic intubation through supraglottic device in second(120 seconds)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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