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We evaluate two new developed airway devices, which provide patent airway during general anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a difficult airway by using an extrication device collar). We then place consecutively both airway devices in the mouth and check for ease of insertion and time used.
The LMA Supremeâ„¢ and the I-gelâ„¢ are both new developed supraglottic airway devices to provide patent airways during general anesthesia. So far, prospective randomized controlled trials comparing their performance are not yet published. Both devices can be used in difficult airway situations, pre-hospital and in the hospital. In this prospective, randomized, controlled cross-over trial, we are going to evaluate the performance of both devices in a simulated difficult airway scenario using an extrication collar to limit both mouth opening and neck movement. In a maximum total of 60 patients undergoing elective surgery, we will place both airway devices consecutively and ventilate the patients. First attempt success rate and time to success will be recorded. Secondary outcomes include oropharyngeal pressure leak, ease of gastric catheter insertion, adverse events and side effects. Our hypothesis is that no difference exists between the two devices. Our 0-hypothesis is that there is a difference
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | crossover trial. insertion of both devices consecutively, computer randomized order |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-gel and LMA Supreme: supraglottic airway devices | Device | Insertion of a supraglottic airway device |
|
| Measure | Description | Time Frame |
|---|---|---|
| first attempt success rate and time to success | during intervention |
| Measure | Description | Time Frame |
|---|---|---|
| leak pressure | during intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Greif, M.D. | Department of Anesthesia, University Hospital Berne, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Bern | Canton of Bern | CH-3010 | Switzerland |
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