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

Not Applicable

Completed

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

• Registration Number: NCT05347680
• 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 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.

Detailed Description

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

Study Timeline

• Study Start: 2019-09-19
• Primary Completion: 2020-01-15
• Study Completion: 2021-01-18
• Status Verified: 2022-04
• Study First Submitted: 2022-04-03
• Study First Submitted QC: 2022-04-20
• Last Update Submitted: 2022-04-20
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• American Society Anesthesiology I and II

Exclusion Criteria

• Difficult intubation
• Cervical pathology
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
intubating laryngeal Tube Suction	Intubating Laryngeal Tube Suction	Fiberoptic Intubation through intubating laryngeal Tube Suction
Ambu AuraGain Laryngeal Mask	Ambu AuraGain Laryngeal Mask	Fiberoptic Intubation through Ambu AuraGain Laryngeal Mask

Primary Outcome Measures

Name	Time	Method
Time to perform fiberoptic intubation through supraglottic device in second	120 seconds	Time to perform endotracheal fiberoptic intubation through supraglottic device in second

Secondary Outcome Measures

Name	Time	Method
Success to obtain fiberoptic intubation through supraglottic device in second	120 seconds	Success to obtain endotracheal fiberoptic intubation through supraglottic device in second

Trial Locations

Locations (1)

Luis A Gaitini M.D.; 🇮🇱 Haifa, Israel