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

Study Overview
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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 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
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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

Official Title
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A Prospective and Randomized Study Comparing the New Intubating Laryngeal Tube Suction and the Ambu AuraGain in Adult Patients

Conditions
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Intubation; Difficult

Intervention / Treatment
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* Device: Intubating Laryngeal Tube Suction
* Device: Ambu AuraGain Laryngeal Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society Anesthesiology I and II Exclusion Criteria: Difficult intubation, Cervical pathology

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intubating laryngeal Tube Suction<br>Intubating laryngeal Tube Suction | Device: Intubating Laryngeal Tube Suction<br>* Intubating Laryngeal Tube Suction<br>Device: Ambu AuraGain Laryngeal Mask<br>* Ambu AuraGain Laryngeal Mask<br>|
| Active Comparator: Ambu AuraGain Laryngeal Mask<br>Ambu AuraGain Laryngeal Mask | Device: Intubating Laryngeal Tube Suction<br>* Intubating Laryngeal Tube Suction<br>Device: Ambu AuraGain Laryngeal Mask<br>* Ambu AuraGain Laryngeal Mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to performe blind intubation measure in second |  | 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to performe fiberoptic intubation in second |  | 60 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubating Laryngeal Tube, blind intubation, fiberoptic