Comparison of Endotracheal Intubation Over the Aintree Via the I-gel and Laryngeal Mask Airway Supreme

Study Overview
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Brief Summary
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The investigators plan to conduct a randomized trial comparing the efficacy of intubating the tracheal using an Aintree intubation catheter through either the LMA-S or I-gel supraglottic devices

Detailed Description
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With the proposal, the investigators are comparing two different types of supraglottic devices. One is the LMA Supreme (laryngeal mask airway) and the other is the I-gel. The study is designed to use the supraglottic airway device as an adjunct to tracheal intubation, not as the definitive airway. The investigators will be utilizing the Aintree intubation catheter over the fiberoptic bronchoscope in an effort to secure the airway. This technique has been well described in the literature and has been proven effective and safe.

Official Title
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Comparison of Endotracheal Intubation Over the Aintree Via the I-gel and Laryngeal Mask Airway Supreme

Conditions
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Difficult Intubation

Intervention / Treatment
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* Device: LMA-Supreme supraglottic device
* Device: I-gel supraglottic device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects that will require routine endotracheal intubation for general anesthesia as part of their surgery. Age >18 years old. Can provide informed consent. Exclusion Criteria: Subjects that require rapid sequence induction for endotracheal intubation; i.e., parturients, or any subject that is at high risk for aspirating gastric contents into the airway. Subjects that have an allergy to Propofol or eggs. Subjects that have an allergy to rocuronium. Subjects with a history of oropharyngeal or laryngeal surgery, or subjects undergoing oropharyngeal or laryngeal surgery. Subjects with congenital or anatomical airway anomalies. Subjects with anticipated reduced functional residual capacity as predicted by a body mass index ≥40. Currently enrolled in another research study.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LMA-Supreme supraglottic device<br>The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff | Device: LMA-Supreme supraglottic device<br>* The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.<br>|
| Active Comparator: I-gel supraglottic device<br>The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff. | Device: I-gel supraglottic device<br>* The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Successful Tracheal Intubation | This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide. | Up to 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Placement of the Supra Glottic Device | This measure of time begins with the handling of the supra glottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide | Up to 10 minutes | 
| Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device | Percent of subjects who required 0, 1, 2, and 3 airway manipulations for the placement of the supraglottic device | Up to 10 minutes | 
| Time to Placement of the Aintree Airway Intubation Catheter | This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down | Up to 10 minutes | 
| Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | Percent of subjects who required 0, 1, 2, 3 and 6 airway manipulations for the placement of the Aintree. | Up to 10 minutes | 
| Time to Placement of the Endotrotracheal Tube | Time to the appropriate placement of the endotracheal tube. | Up to 10 minutes | 
| Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube | Percent of subjects with 0, 1, 2 and 3 airway manipulations required for placement of endotrachial tube | Up to 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation