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

NCT03544749 | Completed

• 1 other identifier: 1803-124-932
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laryngeal Mask; Intubation; Difficult or Failed

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal leak pressure

  Oropharyngeal leak pressure is measured by closing the expiratory valve and administering fresh gas flow of 6 L/min, until the equilibrium pressure is reached (to a maximum of 40 cm of H2O).

  At an average of 30 seconds after insertion of laryngeal mask airway

Secondary Outcomes (14)

• Oropharyngeal leak pressure

  At 5 minute after insertion of laryngeal mask airway

• The time for successful insertion of the device

  During induction of anesthesia, an average of 60 seconds

• Success rate in first attempt

  During induction of anesthesia, an average of 60 seconds

• Overall success rate

  During induction of anesthesia, an average of 60 seconds

• The ease of insertion of device

  During induction of anesthesia, an average of 60 seconds

Study Arms (2)

Ambu® AuraGain™ group

EXPERIMENTAL

Device: Ambu® AuraGain™

I-gel group

ACTIVE COMPARATOR

Device: I-gel

Interventions

Ambu® AuraGain™ DEVICE

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

Ambu® AuraGain™ group

I-gel DEVICE

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

I-gel group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Tae Kyong Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 4, 2018
• Study Start: June 7, 2018
• Primary Completion: September 27, 2018
• Study Completion: October 12, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

KR (1)