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Although VLs improve glottic visualization, on many occasions it may not be accompanied by intubation at the first attempt, because the endotracheal tube has to pass a sharp angle to enter the trachea. To avoid this limitation, a new flexible tip bougie is designed to flexibly navigate the distal tip and help facilitate precise insertion of the endotracheal tube in the trachea. The flexible tip bougie has an integrated slider along the surface which moves the tip anterior and posterior while the pre-curved distal portion of shaft allows the angulation to provide anterior flexion. This new flexible tip bougie could be used as a rescue when first intubation failure using the videolaryngoscopy, or as a first option to improve the percentage of patients intubated at the first attempt.
The purpose of this prospective randomized study is to compare successful intubation on the first attempt with the new flexible tip bougie versus endotracheal tube with stylet during awake intubation with videolaryngoscopy in patients with anticipated difficult airway.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endotracheal Tube with Stylet | Active Comparator | Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet. |
|
| Flexible Tip Bougie | Active Comparator | Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotracheal Tube with Stylet | Device | Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the first attempt intubation success rate (percentage) | To compare the difference in the first attempt intubation success rate (percentage) with the two differents devices compared. | During intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the overall intubation success rate (percentage) | To compare the difference overall intubation success rate (percentage) with the two differents devices compared. | During intubation |
| Difference in the incidence of complications (percentage) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Taboada Muñiz, Ph.D. | Contact | 0034-981950674 | manutabo@yahoo.es | |
| Manuel Taboada Muñiz, Ph.D. | Contact | 678195618 | manuel.taboada.muniz@sergas.es |
| Name | Affiliation | Role |
|---|---|---|
| Manuel Taboada Muñiz, Ph.D. | University Clinical Hospital of Santiago de Compostela | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Hospital of Santiago de Compostela | Recruiting | Santiago de Compostela | A Coruña | 15866 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32312225 | Background | 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. | |
| 29800096 |
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Data types: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved T ypes of analyses: For scientific purpose Mechanisms of data availability: With investigator support
When available: With publication
Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose
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| Flexible Tip Bougie | Device | Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie. |
|
To compare the difference in complications (percentage) with the two different devices compared: Hypoxemia (SpO2) < 90 %, Hypoxemia severe (SpO2) < 80 %, Hypotension defined as systolic blood pressure less than 80 mm Hg, Severe hypotension defined as systolic blood pressure less than 65 mm Hg, Cardiac arrest, death during intubation, Moderate or difficult intubation, oesophageal intubation, pulmonary aspiration, dental injuries. |
| Participants will be followed from the beginning of the intervention to 30 minutes after the intervention |
| Difficulty of intubation | Operator-assessed subjective difficulty of intubation by means of a special analogue numerical scale from 0 to 10, where 0=no subjective difficulty and 10=maximal subjective difficulty | During intubation |
| Modified Cormack-Lehane grade of glottic view | Modified Cormack-Lehane grade of glottic view: I: full view of the glottis IIa: partial view of the glottis IIb: arytenoid or posterior part of the vocal cords just visible III: only epiglottis visible IV: neither glottis nor epiglottis visible | During intubation |
| Additional airway equipment | Need for additional airway equipment | During intubation |
| Number of intubation attempts | Number of intubation attempts | During intubation |
| Background |
| Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496. |