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Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AuraGain | Experimental | 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. |
|
| I-gel | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AuraGain | Device | After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| requirement of additional airway maneuver | including adjustment of head/neck position or insertion depth and taping of the device | during placement/maintenance of the device |
| Measure | Description | Time Frame |
|---|---|---|
| insertion time | during placement of the device | |
| success rate | during placement of the device | |
| ease of gastric tube insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won Uk Koh, M.D., Ph.D. | University of Ulsan, College of Medicine, Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
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| I-gel | Device | After anesthetic induction without neuromuscular blocking agent, I-gel is inserted. |
|
| within 10 minutes after device insertion |
| adverse effect at operating room | aspiration of gastric fluid, hypoxia, SpO2<90%, bronchospasm, dental/tongue/lip trauma, staining of blood on the removed device | during anesthesia |
| postoperative adverse effect | sore throat, hoarseness, airway obstruction | within postoperative 24 hours |
| fiberoptic view of glottis | Brimacombe score | within 10 minutes after device insertion |
| oropharyngeal leak pressure | at 1 minute after device insertion, at 10 minutes after device insertion |