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

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

Study Overview

• Status: Completed
• Conditions: Difficult Intubation
• Intervention / Treatment: Device: LMA-Supreme supraglottic device; Device: I-gel supraglottic device

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • South Texas Veterans Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LMA-Supreme supraglottic device; The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff	Device: LMA-Supreme supraglottic device; 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.
Active Comparator: I-gel supraglottic device; 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; 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.

What is the study measuring?

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
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, 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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visualization Score	The visualization of each of the following structures provides one point, for a maximum score of 7.; Right true vocal cord.; Left true vocal cord.; Right false vocal cord.; Left false vocal cord.; Right posterior cartilage; Left posterior cartilage; Epiglottis	Up to 10 minutes

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Antonio Hernandez, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Intubation
• Other Study ID Numbers: 131507 (Other Identifier: Rutgers Cancer Institute of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO