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We, therefore conducted a randomized cross over study to evaluate the usefulness of this new device use by experienced anesthesiologists in several airway manikin scenarios. We hypothesized that in the hands of experienced anesthesiologists the new Flexible Tip Bougie catheter would perform comparably to the standard bougie catheter) in the normal airway scenario. In the difficult airway (both tongue edema, manual in-line stabilization, or cervical collar stabilization), we hypothesized that the new Flexible Tip Bougie catheter would prove superior to the standard Bougie stylet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal airway | Experimental | intubation in normal aurway condition |
|
| Tongue edema | Experimental | intubation in Tongue edema condition |
|
| Pharyngeal obstruction | Experimental | intubation in Tongue edema condition |
|
| Manual cervical inline stabilization | Experimental | intubation in Manual cervical inline stabilization condition |
|
| Cervical collar stabilization | Experimental | intubation in Cervical collar stabilization condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the standard Bougie stylet for difficult intubation | Device | intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to intubation | time from pick up device to the final placement tube in trachea | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| success of intubation | A failed intubation attempt was defined as an attempt in which the trachea was not intubated, or which required more than 120 seconds to perform | 1 day |
| Number of optimalization maneuvers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lukasz Szarpak, Phd | Lazarski University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lazarski University | Warsaw | Masovia | 02-662 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32312225 | Derived | Ruetzler K, Smereka J, Abelairas-Gomez C, Frass M, Dabrowski M, Bialka S, Misiolek H, Plusa T, Robak O, Aniolek O, Ladny JR, Gorczyca D, Ahuja S, Szarpak L. Comparison of the new flexible tip bougie catheter and standard bougie stylet for tracheal intubation by anesthesiologists in different difficult airway scenarios: a randomized crossover trial. BMC Anesthesiol. 2020 Apr 20;20(1):90. doi: 10.1186/s12871-020-01009-7. |
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data will be available from the main investigator
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Cervical collar stabilization and pharyngeal obstruction | Experimental | intubation in Cervical collar stabilization and pharyngeal obstruction condition |
|
| The new Flexible Tip Bougie catheter | Device | intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter |
|
the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation.
| 1 day |
| Ease of use | self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy | 1 day |
| Dental compression | An independent observer scored the severity of dental compressions, which was calculated based on the number of audible teeth clicks (0; 1; ≥2) with the Laerdal airway trainer, and based on a grading of pressure of the teeth (none = 0; mild = 1; moderate/serve ≥2) on the Simman®3G simulator. At the end of each scenario, each participant scored the ease of use of each intubation method on a visual analogue scale (VAS; from 0=Extremely Easy to 100=Extremely Difficult). | 1 day |