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

A Randomized Comparison of Ambu® AuraGain™ Laryngeal Mask Airway and I-gel in Patients With Simulated Cervical Immobilization

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult or Failed; Laryngeal Mask
• Intervention / Treatment: Device: Ambu® AuraGain™; Device: I-gel

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ambu® AuraGain™ group	Device: Ambu® AuraGain™; After induction of anesthesia, Ambu® AuraGain™ will be inserted for the mechanical ventilation.
Active Comparator: I-gel group	Device: I-gel; After induction of anesthesia, I-gel will be inserted for the mechanical ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 5 minute after insertion of laryngeal mask airway
The time for successful insertion of the device	The total time is measured from the removal of the face mask until bilateral chest rise with the first capnogram upstroke.	During induction of anesthesia, an average of 60 seconds
Success rate in first attempt	Successful insertion of laryngeal mask airway in a first attempt	During induction of anesthesia, an average of 60 seconds
Overall success rate	Successful insertion of laryngeal mask airway in a maximum of three attempts	During induction of anesthesia, an average of 60 seconds
The ease of insertion of device	The ease of placement was assessed using a subjective scale of 1-4 (1= no resistance, 2 = moderate resistance, 3 = high resistance, 4 = inability to place the device)	During induction of anesthesia, an average of 60 seconds
The number of attempts at insertion of device	The number of attempts for successful insertion of laryngeal mask airway	During induction of anesthesia, an average of 60 seconds
The ease of gastric tube placement	The ease of gastric tube placement was graded on a subjective scale (1 = easy, 2 = difficult, 3 = unable to pass)	During induction of anesthesia, an average of 5 minutes
The time for successful gastric tube placement	The insertion time is measured from first handling of the gastric tube to confirmation of its position in the stomach by aspiration of gastric fluid.	During induction of anesthesia, an average of 5 minutes
The grade of fiberoptic bronchoscopic view	The fiberoptic bronchoscopic view is defined as Grade 1, larynx only seen; Grade 2, larynx and epiglottis posterior surface seen; Grade 3, larynx, and epiglottis tip or anterior surface seen-visual obstruction of epiglottis to larynx: < 50%; Grade 4, epiglottis down-folded, and its anterior surface seen-visual obstruction of epiglottis to larynx: > 50%; Grade 5, epiglottis downfolded and larynx cannot be seen directly.	During induction of anesthesia, an average of 5 minutes
Peak inspiratory pressure	Peak inspiratory pressure is recorded from mechanical ventilator.	At 5 minute after insertion of laryngeal mask airway
The number of airway maneuvers required to maintain airway patency	Airway maneuvers required to maintain airway patency, including jaw thrust, head/neck extension and/or device adjustments such as advancement/withdrawal of device, and alterations to cuff volume.	During the surgery, an average of 2 hours after anesthesia induction
The type of airway maneuvers required to maintain airway patency	Airway maneuvers required to maintain airway patency, including jaw thrust, head/neck extension and/or device adjustments such as advancement/withdrawal of device, and alterations to cuff volume.	During the surgery, an average of 2 hours after anesthesia induction
Intraoperative complications	Intraoperative complications including coughing, laryngospasm, bronchospasm, hypoxia (SpO2 < 90%), regurgitation, aspiration, blood staining of the device.	During the surgery, an average of 2 hours after anesthesia induction
Postoperative complications	Postoperative complications including sore throat, hoarseness/dysphonia, jaw, neck or ear pain, persistent cough, tachypnea, stridor, hypoxia (SpO2 < 90%), nausea and vomiting.	An average of 2 hours after extubation

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Tae Kyong Kim, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): September 27, 2018
• Study Completion (Actual): October 12, 2018

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1803-124-932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No