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

B

Bnai Zion Medical Center

Status

Completed

Conditions

Difficult Intubation

Treatments

Device: Intubating Laryngeal Tube Suction
Device: Ambu AuraGain Laryngeal Mask

Study type

Interventional

Funder types

Other

Identifiers

NCT05347680
0132-16

Details and patient eligibility

About

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.

Full 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

Enrollment

80 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • American Society Anesthesiology I and II

Exclusion criteria

  • Difficult intubation
  • Cervical pathology
  • pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

80 participants in 2 patient groups

intubating laryngeal Tube Suction
Active Comparator group
Description:
Fiberoptic Intubation through intubating laryngeal Tube Suction
Treatment:
Device: Intubating Laryngeal Tube Suction
Ambu AuraGain Laryngeal Mask
Active Comparator group
Description:
Fiberoptic Intubation through Ambu AuraGain Laryngeal Mask
Treatment:
Device: Ambu AuraGain Laryngeal Mask

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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