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

Vanderbilt University39 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Difficult Intubation

Interventions

LMA-Supreme supraglottic deviceDEVICE

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.

I-gel supraglottic deviceDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

South Texas Veterans HealthCare System

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 10 minutes

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Up to 10 minutes

Time to Placement of the Endotrotracheal Tube

Time to the appropriate placement of the endotracheal tube.

Time frame: Up to 10 minutes

Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube

Data from ClinicalTrials.gov

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