Skip to main content
OpenTrials
Completed

NCT Number: NCT02476565

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Difficult Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LMA-Supreme supraglottic device

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

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.

Primary outcomes

  1. 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

  1. Time to Placement of the Supra Glottic Device

    Time frame: 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

  2. Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device

    Time frame: Up to 10 minutes

    Percent of subjects who required 0, 1, 2, and 3 airway manipulations for the placement of the supraglottic device

  3. Time to Placement of the Aintree Airway Intubation Catheter

    Time frame: 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

  4. Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.

    Time frame: Up to 10 minutes

    Percent of subjects who required 0, 1, 2, 3 and 6 airway manipulations for the placement of the Aintree.

  5. Time to Placement of the Endotrotracheal Tube

    Time frame: Up to 10 minutes

    Time to the appropriate placement of the endotracheal tube.

  6. Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube

    Time frame: Up to 10 minutes

    Percent of subjects with 0, 1, 2 and 3 airway manipulations required for placement of endotrachial tube

Other outcomes

  1. Visualization Score

    Time frame: Up to 10 minutes

    The visualization of each of the following structures provides one point, for a maximum score of 7.

    • Right true vocal cord.
    • Left true vocal cord.
    • Right false vocal cord.
    • Left false vocal cord.
    • Right posterior cartilage
    • Left posterior cartilage
    • Epiglottis

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 19, 2015
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.