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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia, Surgery

Intervention / Treatment
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* Device: I-Gel Laryngeal Mask Airway
* Device: Ambu Auragain Laryngeal Mask Airway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |