A Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Tube Suction Disposable

Study Overview
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Brief Summary
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Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal intubation is usually achieved by a direct laryngoscope.It is an effective method but requires experience and skill demanding a long learning time.The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Intubating Laryngeal Tube Suction is a new version of the Laryngeal Tube. The aim of this study is to examine the effectiveness of the the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).

Detailed Description
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Control the airways and respiration are an important part of treatment for a trauma casualty. Tracheal intubation an action that allows the insertion of a tube through the vocal cords and fixation by the balloon inflation is a definitive airway. Tracheal intubation is usually achieved by a direct laryngoscope. This method is taught both in the training of doctors and paramedics training. Although it is an effective method requires experience and skill demanding a long learning time The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Laryngeal Tube Suction and others similar devices are known as Supraglottic Airway Devices and are inserted blind in the oropharynx and allow a fast oxygenation and ventilation of the patients. The new generation of these devices allows perform blind intubation directly through a special channel. One of these devices is the Intubating Laryngeal Tube Suction The aim of this study is to examine the effectiveness of the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model). The hypothesis is that definitive airway obtaining with Intubating Laryngeal Tube Suction will be more success and faster compared to the standard way of direct laryngoscope. If the hypothesis is proven, this research will be very important implications for the management of the airway describing pre-hospital and in particular military scenarios.

Official Title
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Establishing a Definitive Airway: A Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Tube Suction Disposable

Conditions
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Adverse Anesthesia Outcome

Intervention / Treatment
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* Device: Intubating Laryngeal Tube Suction
* Device: Direct Laryngoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society Anesthesiology class I and II Exclusion Criteria: Difficult airways Cervical pathology Full stomach

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 |
| --- | --- |
| Experimental: Intubating laryngeal Tube Suction<br>Intubating laryngeal Tube Suction | Device: Intubating Laryngeal Tube Suction<br>* Intubating Laryngeal Tube Suction Disposable<br>|
| Active Comparator: Direct Laryngoscopy<br>Direct Laryngoscopy | Device: Direct Laryngoscopy<br>* Direct Laryngoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blind tracheal intubation time measure in seconds |  | 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Easy of insertion measure in numerical scale | Easy of insertion measure 1 to 5 Numerical scale | 30 seconds | 

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