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Cuff inflation up to the maximum cuff pressure when using LMA flexible can cause sore throat and discomfort after the surgery, and if the surgery is unexpectedly prolonged, there can be a side effect that can cause ischemic damage around the neck. If keeping cuff pressure low will not increase gastric insufflation and there is no change in other outcome variables, keeping it low may have a positive effect on anesthesia management and outcome in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| higher pressure | Placebo Comparator | During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O |
|
| lower pressure | Experimental | During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lower pressure | Behavioral | During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of gastric insufflation(antrum) | Incidence of gastric insufflation which was recognized in gastric antrum with ultrasound | During the surgery(up to 3 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| The size of gastric antrum and body | The size of gastric antrum and body assessed immediately after insertion of LMA flexible and after finishing the surgery | During the surgery(up to 3 hours) |
| Time for insertion of LMA flexible |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin-Tae Kim, PhD | Contact | 82-2-2072-3664 | jintae73@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim, PhD | Seoul National University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D008150 | Lower Body Negative Pressure |
| ID | Term |
|---|---|
| D003664 | Decompression |
| D013812 | Therapeutics |
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| higher pressure | Behavioral | During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O |
|
Time for insertion of LMA flexible
| During the anesthesia induction(up to 1 hour) |
| Success rate of insertion of LMA flexible | Success rate of insertion of LMA flexible | During the anesthesia induction(up to 1 hour) |
| The number of insertion attempt | The number of insertion attempt | During the anesthesia induction(up to 1 hour) |
| The number and the type of additional manipulation for successful ventilation | The number and the type of additional manipulation for successful ventilation | During the surgery(up to 3 hours) |
| Ease of insertion of LMA flexible | Ease of insertion of LMA flexible(very easy, easy, moerate, difficult, very difficult) | During the anesthesia induction(up to 1 hour) |
| Incidence of gastric insufflation(body) | Incidence of gastric insufflation which was recognized in gastric body with ultrasound | During the surgery(up to 3 hours) |
| Incidence of gastric insufflation recognized with the ausculation | Incidence of gastric insufflation recognized with the ausculation after finishing surgery | During the surgery(up to 3 hours) |
| peak pressure observed before, during, after surgery | peak pressure observed before, during, after surgery | During the surgery(up to 3 hours) |
| oropharyngeal leak pressure | oropharyngeal leak pressure will be assessed by setting the APL valve of the circle system at 30 cmH2O with fresh gas flow of 3 L/min after the surgery | During the surgery(up to 3 hours) |
| the complication rate | the complication rate such as desaturation, blood staining of LMA flexible, hoarseness, dental/lip/tongue injury, aspiration | During the surgery and after surgery (up to 6 hours) |