Clinical trial NCT02476565: Comparison of Endotracheal Intubation Over the Aintree Via the I-gel and Laryngeal Mask Airway Supreme
Official title: Comparison of Endotracheal Intubation Over the Aintree Via the I-gel and Laryngeal Mask Airway Supreme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation
Keywords: Intubation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 ≥40.
* Currently enrolled in another research study.

Primary outcomes:
measure: Time to Successful Tracheal Intubation
timeFrame: Up to 10 minutes
Secondary outcomes:
measure: Time to Placement of the Supra Glottic Device
timeFrame: Up to 10 minutes
measure: Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device
timeFrame: Up to 10 minutes
measure: Time to Placement of the Aintree Airway Intubation Catheter
timeFrame: Up to 10 minutes
measure: Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.
timeFrame: Up to 10 minutes
measure: Time to Placement of the Endotrotracheal Tube
timeFrame: Up to 10 minutes
measure: Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube
timeFrame: Up to 10 minutes
Other outcomes:
measure: Visualization Score
timeFrame: Up to 10 minutes
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Veterans HealthCare System
state: Texas
Study officials:
affiliation: Vanderbilt University Medical Center
name: Antonio Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: