Comparison of Endotracheal Intubation Over the Aintree Via the I-gel and Laryngeal Mask Airway Supreme
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vanderbilt University
- Enrollment
- 39
- Locations
- 4
- Primary Endpoint
- Time to Successful Tracheal Intubation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≥
- •Currently enrolled in another research study.
Arms & Interventions
LMA-Supreme supraglottic device
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
Intervention: LMA-Supreme supraglottic device (Device)
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.
Intervention: I-gel supraglottic device (Device)
Outcomes
Primary Outcomes
Time to Successful Tracheal Intubation
Time Frame: Up 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 Outcomes
- Time to Placement of the Endotrotracheal Tube(Up to 10 minutes)
- Time to Placement of the Supra Glottic Device(Up to 10 minutes)
- Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device(Up to 10 minutes)
- Time to Placement of the Aintree Airway Intubation Catheter(Up to 10 minutes)
- 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 With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube(Up to 10 minutes)
Investigators
Antonio Hernandez
Assoc Professor of Clinical Anesthesiology
Vanderbilt University