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

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT04286581
• Collaborator: (none)
• Enrollment: 151
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.3
• Patients Per Site Per Month: 20.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Surgery	Device: I-Gel Laryngeal Mask Airway; Device: Ambu Auragain Laryngeal Mask Airway	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model 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.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.
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in Adult Patients at an Ambulatory Surgery Center
• Actual Study Start Date: Mar 22, 2021
• Actual Primary Completion Date: Oct 31, 2021
• Actual Study Completion Date: Oct 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Oropharyngeal Leak Pressure (OLP) [4 hours]

   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.

Secondary Outcome Measures

1. Time to Placement [4 hours]

   Time required to place laryngeal mask airway will be measured and reported in seconds.

2. Insertion Attempts [4 hours]

   Number of attempts required for successful insertion of laryngeal mask airway.

3. First Attempt Success Rate [4 hours]

   Percent of laryngeal mask airway placements that are successful upon first attempt.

4. Ease of Insertion [4 hours]

   The clinician who places the laryngeal mask airway will be asked to rate ease of insertion on a four point rating scale: 1, no resistance; 2, mild resistance; 3, moderate resistance; and 4, inability to place device. Outcome will be reported as the mean score per group.

5. Number of Mid-Case Adjustments [4 hours]

   Number of adjustments made to laryngeal mask airway following insertion.

6. Sore Throat [8 hours, 24 hours]

   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.

7. Blood staining of Laryngeal Mask Airway [4 hours]

   Upon removal, staff will observe the laryngeal mask airway for the presence of blood and report a yes or no value. Number of devices with blood staining will be reported per group.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT04286581
• Other Study ID Numbers: ANES-2020-28604
• First Posted: Feb 27, 2020
• Last Update Posted: Mar 7, 2022
• Last Verified: Mar 1, 2022

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

Study Results

No Results Posted as of Mar 7, 2022