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

NCT04286581 | Completed Results FDA Device

• 1 other identifier: ANES-2020-28604
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to Placement

  time from opening mouth to successful placement (4 hours)

• Sore Throat

  Pain right before discharge from pacu (8 hours)

• Sore Throat

  24 hours post-surgery

Study Arms (2)

Igel Larnygeal Mask Airway

EXPERIMENTAL

Group 1 will receive the I-Gel Laryngeal Mask Airway for airway maintenance during general anesthesia

Device: I-Gel Laryngeal Mask Airway

Ambu Auragain Laryngeal mask airway

ACTIVE COMPARATOR

Group 2 will receive the Ambu Auragain Laryngeal Mask Airway for airway maintenance during general anesthesia

Device: Ambu Auragain Laryngeal Mask Airway

Interventions

I-Gel Laryngeal Mask Airway DEVICE

The I-Gel Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness.

Igel Larnygeal Mask Airway

Ambu Auragain Laryngeal Mask Airway DEVICE

The Ambu Auragain Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness.

Ambu Auragain Laryngeal mask airway

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Results Point of Contact

• Title: Dr. Jacob Hutchins, MD
• Organization: University of Minnesota

hutc0079@umn.edu

612-624-9990

Study Officials

• Jacob Hutchins, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: February 24, 2020
• First Posted: February 27, 2020
• Study Start: March 22, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: December 19, 2022
• Results First Posted: December 19, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)