A Comparison of Ambu® AuraGain™ Laryngeal Mask Airway and I-gel in Adult

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-07

Study Completion Date

2018-10-12

Brief Summary

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The supraglottic airway device(SAD), as an alternative to the endotracheal tube is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. SAD has evolved in recent years to increase efficiency and secure safety. The recently developed Ambu® AuraGain™ is a second-generation SAD with a built-in gastric port and is designed to be fitted well in the larynx and oral cavity after insertion because the shaft is bent at an angle of 90 degrees and has an inflatable cuff.

In a previous study, Ambu® AuraGain™ showed a higher sealing pressure and better fibreoptic finding compared to LMA Supreme in laparoscopic surgery.

On the other hand, I-gel and Ambu® AuraGain™, both of the second-generation SAD, show comparatively excellent performance according to the results of previous studies. However, there are no studies comparing the characteristics of two airway devices in adults.

The purpose of this study is to compare the performance of I-gel and Ambu® AuraGain™ to make a difficult airway-like situation using cervical collar for adult patients receiving mechanical ventilation under general anesthesia.

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Detailed Description

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Conditions

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Laryngeal Mask Intubation; Difficult or Failed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ambu® AuraGain™ group

Group Type EXPERIMENTAL

Ambu® AuraGain™

Intervention Type DEVICE

After induction of anesthesia, Ambu® AuraGain™ will be inserted for the mechanical ventilation.

I-gel group

Group Type ACTIVE_COMPARATOR

I-gel

Intervention Type DEVICE

After induction of anesthesia, I-gel will be inserted for the mechanical ventilation.

Interventions

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Ambu® AuraGain™

After induction of anesthesia, Ambu® AuraGain™ will be inserted for the mechanical ventilation.

Intervention Type DEVICE

I-gel

After induction of anesthesia, I-gel will be inserted for the mechanical ventilation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who are undergoing surgery under general anesthesia where supraglottic airway management will be appropriate.

Exclusion Criteria

* Body mass index \> 35 kg/m2
* High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
* Criteria for difficult airway
* Patients with cervical disease or previous cervical spine surgery

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No