The New Intubating Laryngeal Tube Suction-Disposable

Study Overview
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Brief Summary
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The study compares the intubating Laryngeal Tube Suction (iLTS-D) with the Ambu®AuraGain™ in blind and fibreoptic endotracheal intubation. The current randomized study is designed to assess the success rate of blind and fibreoptic endotracheal intubation using i-LTS-D, in comparison with the Air-Q, i-gel® and Ambu®AuraGain™ in an airway simulator. The investigators hypothesize that the iLTS-D and the Supreme Laryngeal Mask Airway will similarly perform during spontaneous ventilation despite differences in their structural design.

Detailed Description
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The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik, 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 fibreoptic guidance. Similarly to the LTS-D, the iLTS-D also has a separate channel for gastric tubes placement up to a size of 18 Fr. The current randomized study was designed to assess the success rate of blind and fibreoptic endotracheal intubation using iLTS-D, in comparison with the Ambu® AuraGain™ in adult patients under general anesthesia.

Official Title
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A Comparative Randomized Prospective Study Between the New Intubating Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Blind and Fibreoptic-guided Intubation

Conditions
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Adverse Anesthesia Outcome

Intervention / Treatment
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* Device: Intubation laryngeal Tube Suction
* Device: 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of blind intubation measure in seconds |  | 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Fiberoptic intubation measure in seconds |  | 60 seconds | 

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