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Completed

NCT Number: NCT05347680

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

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.

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Key information

Conditions

Difficult Intubation

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luis A Gaitini M.D.

Haifa, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society Anesthesiology I and II

Exclusion criteria

  • Difficult intubation
  • Cervical pathology
  • pregnancy

Treatment and study plan

Intubating Laryngeal Tube Suction

Device

Intubating Laryngeal Tube Suction

Ambu AuraGain Laryngeal Mask

Device

Ambu AuraGain Laryngeal Mask

Primary outcomes

  1. Time to perform fiberoptic intubation through supraglottic device in second

    Time frame: 120 seconds

    Time to perform endotracheal fiberoptic intubation through supraglottic device in second

Secondary outcomes

  1. Success to obtain fiberoptic intubation through supraglottic device in second

    Time frame: 120 seconds

    Success to obtain endotracheal fiberoptic intubation through supraglottic device in second

Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 26, 2022
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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