A Comparison Between the Intubating Laryngeal Tube Suction and the Ambu AuraGain

Not Applicable

• Conditions: Intubation; Difficult
• Interventions: Device: Intubating Laryngeal Tube Suction; Device: Ambu AuraGain Laryngeal Mask

• Registration Number: NCT02878005
• Lead Sponsor: Bnai Zion Medical Center

Brief Summary

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.

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) 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

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Primary Completion: 2016-08
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-24
• Last Update Submitted: 2016-08-24
• Study First Posted: 2016-08-25
• Last Update Posted: 2016-08-25
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

American Society Anesthesiology I and II

Exclusion Criteria

Difficult intubation, Cervical pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intubating laryngeal Tube Suction	Ambu AuraGain Laryngeal Mask	Intubating laryngeal Tube Suction
Intubating laryngeal Tube Suction	Intubating Laryngeal Tube Suction	Intubating laryngeal Tube Suction
Ambu AuraGain Laryngeal Mask	Ambu AuraGain Laryngeal Mask	Ambu AuraGain Laryngeal Mask
Ambu AuraGain Laryngeal Mask	Intubating Laryngeal Tube Suction	Ambu AuraGain Laryngeal Mask

Primary Outcome Measures

Name	Time	Method
Time to performe blind intubation measure in second	30 seconds

Secondary Outcome Measures

Name	Time	Method
Time to performe fiberoptic intubation in second	60 seconds