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The study has to show that an intubation with the AuraGain Laryngeal mask could bring the same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AuraGain | Active Comparator | The patient will get a fiberoptic Intubation via the AuraGain larynxmask |
|
| Slotted Guedeltubus | Placebo Comparator | The patient will get a fiberoptic intubation via the slotted Guedeltubus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AuraGain | Procedure | Fiberoptic Intubation |
| |
| Slotted Guedeltubus |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation time | Time to complete the Intubation in seconds | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation attempts | The number of intubation attempts will be recorded (eg 1, 2, 3...) | Intraoperative |
| Esophagal Intubation attempts | The number of esophagal intubation attempts will be recorded (eg 1, 2, 3...) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Moser, MD | Schulthess Klinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schulthess Klinik | Zurich | 8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28718101 | Derived | Moser B, Audige L, Keller C, Brimacombe J, Gasteiger L, Bruppacher HR. Flexible bronchoscopic intubation through the AuraGain laryngeal mask versus a slit Guedel tube: a non-inferiority randomized-controlled trial. Can J Anaesth. 2017 Nov;64(11):1119-1128. doi: 10.1007/s12630-017-0936-7. Epub 2017 Jul 17. |
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| Procedure |
Fiberoptic Intubation |
|
| Intraoperative |
| Resistance measurement of the Insertion as assessed by a four point scoring system | 1/2/3/4 | Intraoperative |
| Position of the mask as assessed by the Brimacombe Score | 4/3/2/1 | Intraoperative |
| Pain after Intubation as assessed by a Numeric Rating Scale | mild/moderate/severe | Intraoperative/2h postoperative/24h postoperative |
| AE/Complications | Occuring AE/Complications will be recorded | Intraoperative/postoperative until 24h |