Comparison of AuraGain With I-gel for Pediatric Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03294226|
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|General Anesthesia||Device: AuraGain Device: I-gel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Trial of Ambu® AuraGain™ Versus I-gel® in Young Children|
|Actual Study Start Date :||September 25, 2017|
|Actual Primary Completion Date :||March 23, 2018|
|Actual Study Completion Date :||March 24, 2018|
After anesthetic induction, AuraGain is inserted for airway management. Size of the device is selected according to the manufacturer's recommendation; size 1.5 for 5-10kg, size 2 for 10-20kg.
After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.
Active Comparator: I-gel
After anesthetic induction, I-gel is inserted for airway management. Size of the device is selected according to the patient's weight; size 1.5 for 5-10kg, size 2 for 10-20kg.
After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.
- requirement of additional airway maneuver [ Time Frame: during placement/maintenance of the device ]including adjustment of head/neck position or insertion depth and taping of the device
- insertion time [ Time Frame: during placement of the device ]
- success rate [ Time Frame: during placement of the device ]
- ease of gastric tube insertion [ Time Frame: within 10 minutes after device insertion ]
- adverse effect at operating room [ Time Frame: during anesthesia ]aspiration of gastric fluid, hypoxia, SpO2<90%, bronchospasm, dental/tongue/lip trauma, staining of blood on the removed device
- postoperative adverse effect [ Time Frame: within postoperative 24 hours ]sore throat, hoarseness, airway obstruction
- fiberoptic view of glottis [ Time Frame: within 10 minutes after device insertion ]Brimacombe score
- oropharyngeal leak pressure [ Time Frame: at 1 minute after device insertion, at 10 minutes after device insertion ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294226
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 05505|
|Principal Investigator:||Won Uk Koh, M.D., Ph.D.||University of Ulsan, College of Medicine, Asan Medical Center|