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| Name | Class |
|---|---|
| Krankenhaus Bozen | OTHER |
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The Ambu-Aura GainTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMA SupremeTM | Active Comparator | function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion |
|
| Ambu-Aura GainTM | Active Comparator | function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| function tests | Procedure | ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| oropharyngeal seal pressure | Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O). | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| anatomic position | The anatomic position was assessed by passing a fiberoptic scope through the airway tube stopping 0,5 cm prior to the end of the tube. The airway tube view was scored using an established scoring system. | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Keller, MD MSc | Contact | ++41443857462 | christian.keller@kws.ch |
| Name | Affiliation | Role |
|---|---|---|
| Christian Keller, MD MSc | Schulthess Klinik | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentralkrankenhaus Bozen | Bolzano | 39100 | Italy |
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| ID | Term |
|---|---|
| D010979 | Platelet Function Tests |
| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| LMA SupremeTM | Device |
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| Ambu-Aura GainTM | Device |
|
| Schulthess Klinik | Zurich | 8008 | Switzerland |
|
| D008919 | Investigative Techniques |