A Randomized Comparison of Ambu® AuraGain™ Laryngeal Mask Airway and I-gel in Patients With Simulated Cervical Immobilization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Oropharyngeal leak pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
I-gel group
Intervention: I-gel (Device)
Ambu® AuraGain™ group
Intervention: Ambu® AuraGain™ (Device)
Outcomes
Primary Outcomes
Oropharyngeal leak pressure
Time Frame: At an average of 30 seconds after insertion of laryngeal mask airway
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).
Secondary Outcomes
- Oropharyngeal leak pressure(At 5 minute after insertion of laryngeal mask airway)
- The time for successful gastric tube placement(During induction of anesthesia, an average of 5 minutes)
- The number of airway maneuvers required to maintain airway patency(During the surgery, an average of 2 hours after anesthesia induction)
- Overall success rate(During induction of anesthesia, an average of 60 seconds)
- The time for successful insertion of the device(During induction of anesthesia, an average of 60 seconds)
- The grade of fiberoptic bronchoscopic view(During induction of anesthesia, an average of 5 minutes)
- Postoperative complications(An average of 2 hours after extubation)
- The number of attempts at insertion of device(During induction of anesthesia, an average of 60 seconds)
- The ease of gastric tube placement(During induction of anesthesia, an average of 5 minutes)
- Intraoperative complications(During the surgery, an average of 2 hours after anesthesia induction)
- Success rate in first attempt(During induction of anesthesia, an average of 60 seconds)
- The ease of insertion of device(During induction of anesthesia, an average of 60 seconds)
- Peak inspiratory pressure(At 5 minute after insertion of laryngeal mask airway)
- The type of airway maneuvers required to maintain airway patency(During the surgery, an average of 2 hours after anesthesia induction)
Investigators
Tae Kyong Kim
Clinical professor
Seoul National University Hospital