Skip to main content
Clinical Trials/NCT02476565
NCT02476565
Completed
Not Applicable

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

Vanderbilt University2 sites in 1 country39 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Difficult Intubation
Sponsor
Vanderbilt University
Enrollment
39
Locations
2
Primary Endpoint
Time to Successful Tracheal Intubation
Status
Completed
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
September 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Antonio Hernandez

Assoc Professor of Clinical Anesthesiology

Vanderbilt University

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 ≥
  • Currently enrolled in another research study.

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)

Study Sites (2)

Loading locations...

Similar Trials