Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Mask Airway

Study Overview
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Brief Summary
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Control the airways by endotracheal intubation is an important part of treatment for a trauma casualty. The use of the Laryngeal Mask Airway for fast control of the airway is known for many years. The aim of this study is to examine the effectiveness of the Intubating Laryngeal Mask Airway to achieve a definitive airway by unskilled practitioners. The hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway will be more success and faster compared to the standard way of direct laryngoscope.

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. The use of the Laryngeal Mask Airway for fast control of the airway is known for many years. The Laryngeal Mask Airway 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 aim of this study is to examine the effectiveness of the Laryngeal Mask Airway 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 Mask Airway 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: Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Mask Airway

Conditions
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Adverse Anesthesia Outcome

Intervention / Treatment
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* Device: Intubating Laryngeal Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society Anesthesiology class I and II Exclusion Criteria: Difficult airway 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 Mask<br>Intubating laryngeal Mask | Device: Intubating Laryngeal Mask<br>* Direct laryngoscopy<br>|
| Active Comparator: Direct laryngoscopy<br>Intubating laryngeal Mask | Device: Intubating Laryngeal Mask<br>* Direct laryngoscopy<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 second | Time of blind intubation in seconds | 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Easy to perform intubation measure in numeric scale | Easy of intubation in numerical scale from 1 to 10 | 30 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blind intubation,, Laryngeal Mask Airway