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

Study Overview
=================
Brief Summary
-----------------
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
-----------------
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

Official 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:

Conditions
-----------------
Difficult Intubation

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


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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>Fiberoptic Intubation through intubating laryngeal Tube Suction | Device: Intubating Laryngeal Tube Suction<br>* Intubating Laryngeal Tube Suction<br>|
| Active Comparator: Ambu AuraGain Laryngeal Mask<br>Fiberoptic Intubation through Ambu AuraGain Laryngeal Mask | Device: Ambu AuraGain Laryngeal Mask<br>* Ambu AuraGain Laryngeal Mask<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to perform fiberoptic intubation through supraglottic device in second | Time to perform endotracheal fiberoptic intubation through supraglottic device in second | 120 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success to obtain fiberoptic intubation through supraglottic device in second | Success to obtain endotracheal fiberoptic intubation through supraglottic device in second | 120 seconds | 

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