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Although the safety and efficacy of the I gel in children has been shown in several large observational studies, There is no study about comparison of the clinical efficacy between I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme are new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel and LMA Supreme in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and LMA Supreme in infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1) I gel group | Experimental | using supraglottic airway I gel |
|
| 2) LMA Supreme group | Active Comparator | using supraglottic airway LMA Supreme |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I gel | Device |
| ||
| LMA Supreme |
| Measure | Description | Time Frame |
|---|---|---|
| airway leak pressure | Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 30 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached. | within 5 min of insertion of each device |
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Inclusion Criteria:
1. Infants (0-1 year of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
Exclusion Criteria:
1. Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeong-Rim LEE, MD | Contact | 02-2227-3840 | MANYA@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine | Recruiting | Seoul | Seoul | 120-752 | South Korea |
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