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

Study Overview
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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.

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

Conditions
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Laryngeal Mask, Intubation; Difficult or Failed

Intervention / Treatment
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* Device: Ambu® AuraGain™
* Device: I-gel


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |