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

NCT ID: NCT04286581

Last Updated: 2022-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-22

Study Completion Date

2021-10-31

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.

Conditions

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Anesthesia Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Igel Larnygeal Mask Airway

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

Group Type EXPERIMENTAL

I-Gel Laryngeal Mask Airway

Intervention Type DEVICE

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

Ambu Auragain Laryngeal mask airway

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

Group Type ACTIVE_COMPARATOR

Ambu Auragain Laryngeal Mask Airway

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Hutchins, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ANES-2020-28604

Identifier Type: -

Identifier Source: org_study_id