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

Vanderbilt University

Status: Completed

Conditions: Difficult Intubation

Treatments: Device: LMA-Supreme supraglottic device; Device: I-gel supraglottic device

Study type: Interventional

Funder types: Other

Identifiers

NCT02476565

131507

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

LMA-Supreme supraglottic device

Experimental group

Description:

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

Treatment:

Device: LMA-Supreme supraglottic device

I-gel supraglottic device

Active Comparator group

Description:

The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.

Treatment:

Device: I-gel supraglottic device