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

Not Applicable
Completed
Conditions
Difficult Intubation
Interventions
Device: LMA-Supreme supraglottic device
Device: I-gel supraglottic device
Registration Number
NCT02476565
Lead Sponsor
Vanderbilt University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
39
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LMA-Supreme supraglottic deviceLMA-Supreme supraglottic deviceThe LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
I-gel supraglottic deviceI-gel supraglottic deviceThe I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
Primary Outcome Measures
NameTimeMethod
Time to Successful Tracheal IntubationUp to 10 minutes

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.

Secondary Outcome Measures
NameTimeMethod
Time to Placement of the Supra Glottic DeviceUp to 10 minutes

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

Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic DeviceUp to 10 minutes

Percent of subjects who required 0, 1, 2, and 3 airway manipulations for the placement of the supraglottic device

Time to Placement of the Aintree Airway Intubation CatheterUp to 10 minutes

This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down

Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.Up to 10 minutes

Percent of subjects who required 0, 1, 2, 3 and 6 airway manipulations for the placement of the Aintree.

Time to Placement of the Endotrotracheal TubeUp to 10 minutes

Time to the appropriate placement of the endotracheal tube.

Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial TubeUp to 10 minutes

Percent of subjects with 0, 1, 2 and 3 airway manipulations required for placement of endotrachial tube

Trial Locations

Locations (2)

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

South Texas Veterans HealthCare System

🇺🇸

San Antonio, Texas, United States

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