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

NCT02476565 | Completed Results

• 1 other identifier: 131507
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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

Conditions

Difficult Intubation

Keywords

Intubation

Outcome Measures

Primary Outcomes (1)

• Time to Successful Tracheal Intubation

  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.

  Up to 10 minutes

Secondary Outcomes (6)

• 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

• Time to Placement of the Endotrotracheal Tube

  Up to 10 minutes

Other Outcomes (1)

• Visualization Score

  Up to 10 minutes

Study Arms (2)

LMA-Supreme supraglottic device

EXPERIMENTAL

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

Device: LMA-Supreme supraglottic device

I-gel supraglottic device

ACTIVE COMPARATOR

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

Device: I-gel supraglottic device

Interventions

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.

LMA-Supreme supraglottic device

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.

I-gel supraglottic device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects that will require routine endotracheal intubation for general anesthesia as part of their surgery.
• Age \>18 years old.
• Can provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (2)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

South Texas Veterans HealthCare System

San Antonio, Texas, 78229, United States

Location

Results Point of Contact

• Title: Antonio Hernandez, MD
• Organization: Vanderbilt University Medical Center

antonio.hernandez@vanderbilt.edu

615 322-4650

Study Officials

• Antonio Hernandez, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor of Clinical Anesthesiology

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 19, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 16, 2018
• Results First Posted: January 18, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)