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

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Laryngeal Mask
Intubation; Difficult or Failed

Treatments

Device: I-gel
Device: Ambu® AuraGain™

Study type

Interventional

Funder types

Other

Identifiers

NCT03544749
1803-124-932

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

104 participants in 2 patient groups

Ambu® AuraGain™ group
Experimental group
Treatment:
Device: Ambu® AuraGain™
I-gel group
Active Comparator group
Treatment:
Device: I-gel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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