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

NCT ID: NCT05347680

Last Updated: 2022-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-19

Study Completion Date

2021-01-18

Brief Summary

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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

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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

Conditions

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Difficult Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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intubating laryngeal Tube Suction

Fiberoptic Intubation through intubating laryngeal Tube Suction

Group Type ACTIVE_COMPARATOR

Intubating Laryngeal Tube Suction

Intervention Type DEVICE

Intubating Laryngeal Tube Suction

Ambu AuraGain Laryngeal Mask

Fiberoptic Intubation through Ambu AuraGain Laryngeal Mask

Group Type ACTIVE_COMPARATOR

Ambu AuraGain Laryngeal Mask

Intervention Type DEVICE

Ambu AuraGain Laryngeal Mask

Interventions

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Intubating Laryngeal Tube Suction

Intubating Laryngeal Tube Suction

Intervention Type DEVICE

Ambu AuraGain Laryngeal Mask

Ambu AuraGain Laryngeal Mask

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* American Society Anesthesiology I and II

Exclusion Criteria

* Difficult intubation
* Cervical pathology
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis Gaitini, Prof

Role: PRINCIPAL_INVESTIGATOR

Bani Zion Medical Center Haifa ISRAEL

Locations

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Luis A Gaitini M.D.

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0132-16

Identifier Type: -

Identifier Source: org_study_id

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