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The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway and LMA Supreme in normal airway patients.
Ambu AuraGain Laryngeal Mask Airway is a newly designed supraglottic device. We design this study to test its clinical performance in normal airway patients, in comparison with LMA Supreme.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambu AuraGain | Experimental | Subjects will receive the Ambu AuraGain size 3 to size 5 based on manufacturer guidelines |
|
| LMA Supreme | Active Comparator | Subjects will receive the LMA Supreme size 3 to size 5 based on manufacturer guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambu AuraGain | Device |
| ||
| LMA Supreme |
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal leak pressure | The airway pressure at which an airway leak is observed after successful placement of the device | Up to 1 minute after the time of confirmed device placement |
| Measure | Description | Time Frame |
|---|---|---|
| Insertion time | Time needed to insert the device | Up to 1 minute on each insertion attempt |
| Ease of insertion | Number of attempts to place the device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Juhui, MD | Contact | +8615210258001 | liujuhui2006@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Liu Juhui, MD | Plastic Surgery Hospital, ChineseAMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ChineseAMS | Recruiting | Beijing | Beijing Municipality | 100144 | China |
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Parellel Assignment
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|
| Up to 1 minute on each insertion attempt |
| Fiberoptic Grade of Laryngeal View | Fiberoptic Grade of Laryngeal View through each device will be graded using a previously grading system | Up to 1 minute after placement of device |
| Postoperative Complications | Patient will be evaluated for sore throat, dysphonia, stridor, dysphagia, blood stain on device | 2 hours after removal of the device |