Comparison of Endotracheal Intubation Over the Aintree Via the I-gel and Laryngeal Mask Airway Supreme
- Conditions
- Difficult Intubation
- Interventions
- Device: LMA-Supreme supraglottic deviceDevice: 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
- Subjects that will require routine endotracheal intubation for general anesthesia as part of their surgery.
- Age >18 years old.
- Can provide informed consent.
- 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
Group Intervention Description LMA-Supreme supraglottic device LMA-Supreme supraglottic device The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff I-gel supraglottic 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.
- Primary Outcome Measures
Name Time Method Time to Successful Tracheal Intubation 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 Outcome Measures
Name Time Method Time to Placement of the Supra Glottic Device Up 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 Device Up 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 Catheter Up 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 Tube Up 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 Tube Up 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