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

Not Applicable

Completed

• Conditions: Anesthesia; Surgery
• Interventions: Device: I-Gel Laryngeal Mask Airway; Device: Ambu Auragain Laryngeal Mask Airway

• Registration Number: NCT04286581
• Lead Sponsor: University of Minnesota

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-27
• Study Start: 2021-03-22
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Results First Submitted: 2022-10-26
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-23
• Last Update Submitted: 2022-11-23
• Results First Posted: 2022-12-19
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Igel Larnygeal Mask Airway	I-Gel Laryngeal Mask Airway	Group 1 will receive the I-Gel Laryngeal Mask Airway for airway maintenance during general anesthesia
Ambu Auragain Laryngeal mask airway	Ambu Auragain Laryngeal Mask Airway	Group 2 will receive the Ambu Auragain Laryngeal Mask Airway for airway maintenance during general anesthesia

Primary Outcome Measures

Name	Time	Method
Oropharyngeal Leak Pressure (OLP)	immediately after placement	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

Name	Time	Method
Sore Throat	24 hours post-surgery	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.
Time to Placement	time from opening mouth to successful placement (4 hours)	Time required to place laryngeal mask airway will be measured and reported in seconds.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States