Comparison of Ambu Auragain and I-Gel Supraglottic Airways in Adult Patients at an Ambulatory Surgery Center

The purpose of this study is to determine if an I-gel laryngeal mask airway (LMA) has a higher oropharyngeal leak pressure compared to an Ambu Auragain in adult patients in an ambulatory surgery center.

Study Overview

• Status: Completed
• Conditions: Surgery; Anesthesia
• Intervention / Treatment: Device: I-Gel Laryngeal Mask Airway; Device: Ambu Auragain Laryngeal Mask Airway

Detailed Description

Patients who are scheduled for elective ambulatory surgery under general anesthesia will be randomized to one of two groups. Group 1 will receive an I-gel laryngeal mask airway (LMA) and group 2 will receive an Ambu Auragain LMA.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- undergoing outpatient ambulatory surgery under general anesthesia that is amenable to using a laryngeal mask airway

Exclusion Criteria:

• non-English speaking patients
• patients with abnormal airway anatomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Igel Larnygeal Mask Airway; Group 1 will receive the I-Gel Laryngeal Mask Airway for airway maintenance during general anesthesia	Device: I-Gel Laryngeal Mask Airway; The I-Gel Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness.
Active Comparator: Ambu Auragain Laryngeal mask airway; Group 2 will receive the Ambu Auragain Laryngeal Mask Airway for airway maintenance during general anesthesia	Device: Ambu Auragain Laryngeal Mask Airway; The Ambu Auragain Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal Leak Pressure (OLP)	OLP will be measured immediately after insertion. This will be accomplished by closing the expiratory valve while keeping fresh gas flow at 3 liters/minute until equilibrium is reached. Pressure will be reported in cmH2O.	immediately after placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Placement	Time required to place laryngeal mask airway will be measured and reported in seconds.	time from opening mouth to successful placement (4 hours)
Sore Throat	Participants will be asked upon discharge from recovery room (approximately 8 hours post surgery) to rate the soreness of their throat on a numerical rating scale of 0-10 (0 being no soreness and 10 being maximum imaginable soreness). Participants will be asked to rate throat soreness again via phone call approximately 24 hours after surgery.	Pain right before discharge from pacu (8 hours)
Sore Throat	Participants will be asked upon discharge from recovery room (approximately 8 hours post surgery) to rate the soreness of their throat on a numerical rating scale of 0-10 (0 being no soreness and 10 being maximum imaginable soreness). Participants will be asked to rate throat soreness again via phone call approximately 24 hours after surgery.	24 hours post-surgery

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jacob Hutchins, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ANES-2020-28604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No