Clinical trial NCT03544749: A Comparison of Ambu® AuraGain™ Laryngeal Mask Airway and I-gel in Adult
Official title: A Randomized Comparison of Ambu® AuraGain™ Laryngeal Mask Airway and I-gel in Patients With Simulated Cervical Immobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Mask
Intubation; Difficult or Failed
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: At an average of 30 seconds after insertion of laryngeal mask airway
Secondary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: At 5 minute after insertion of laryngeal mask airway
measure: The time for successful insertion of the device
timeFrame: During induction of anesthesia, an average of 60 seconds
measure: Success rate in first attempt
timeFrame: During induction of anesthesia, an average of 60 seconds
measure: Overall success rate
timeFrame: During induction of anesthesia, an average of 60 seconds
measure: The ease of insertion of device
timeFrame: During induction of anesthesia, an average of 60 seconds
measure: The number of attempts at insertion of device
timeFrame: During induction of anesthesia, an average of 60 seconds
measure: The ease of gastric tube placement
timeFrame: During induction of anesthesia, an average of 5 minutes
measure: The time for successful gastric tube placement
timeFrame: During induction of anesthesia, an average of 5 minutes
measure: The grade of fiberoptic bronchoscopic view
timeFrame: During induction of anesthesia, an average of 5 minutes
measure: Peak inspiratory pressure
timeFrame: At 5 minute after insertion of laryngeal mask airway
measure: The number of airway maneuvers required to maintain airway patency
timeFrame: During the surgery, an average of 2 hours after anesthesia induction
measure: The type of airway maneuvers required to maintain airway patency
timeFrame: During the surgery, an average of 2 hours after anesthesia induction
measure: Intraoperative complications
timeFrame: During the surgery, an average of 2 hours after anesthesia induction
measure: Postoperative complications
timeFrame: An average of 2 hours after extubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Tae Kyong Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: