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

Difficult Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476565
• Other study ID #: 131507
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: February 15, 2018
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: February 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Difficult Intubation

Intervention

Device:
• LMA-Supreme supraglottic 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
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	South Texas Veterans HealthCare System	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visualization Score	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	Up to 10 minutes
Primary	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	Time to Placement of the Supra Glottic Device	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	Up to 10 minutes
Secondary	Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device	Percent of subjects who required 0, 1, 2, and 3 airway manipulations for the placement of the supraglottic device	Up to 10 minutes
Secondary	Time to Placement of the Aintree Airway Intubation Catheter	This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down	Up to 10 minutes
Secondary	Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.	Percent of subjects who required 0, 1, 2, 3 and 6 airway manipulations for the placement of the Aintree.	Up to 10 minutes
Secondary	Time to Placement of the Endotrotracheal Tube	Time to the appropriate placement of the endotracheal tube.	Up to 10 minutes
Secondary	Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube	Percent of subjects with 0, 1, 2 and 3 airway manipulations required for placement of endotrachial tube	Up to 10 minutes