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

NCT ID: NCT02476565

Last Updated: 2018-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-09-30

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.

Conditions

Difficult Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LMA-Supreme supraglottic device

The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff

Group Type: EXPERIMENTAL

LMA-Supreme supraglottic device

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

I-gel supraglottic device

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Antonio Hernandez

Assoc Professor of Clinical Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

South Texas Veterans HealthCare System

San Antonio, Texas, United States

Countries

United States

Other Identifiers

131507

Identifier Type: -

Identifier Source: org_study_id