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Patients with anticipated difficult airway are recommended to be managed with an awake tracheal intubation. Initially fibreoptic bronchoscopy was considered the gold standard, but in the last decade videolaryngoscopes have been demonstrated to be an efficacy alternative technique. Recently, a systematic review and meta-analysis was published investigating the efficacy and safety of videolaryngoscopy compared with fibreoptic bronchoscopy for awake tracheal intubation. Eight prospective, randomized studies were included, with different videolaryngoscopes (C-MAC, GlideScope, Pentax AWS, McGraft, and Bullard). However, a direct comparison of two different videolaryngoscopes for awake tracheal intubation in patients with anticipated difficult airway has not been performed.
This is a clinical prospective randomized-controlled trial. The aim of this study is to compare two different devices (C-MAC videolaryngoscope and Airtraq videolaryngoscope) for awake tracheal intubation in patients with difficult airways scheduled for surgery. The primary endpoint will be to compare first-attempt intubation success rate between the two videolaryngoscopes. Secondary outcomes will be to compare: difference in the overall success rate, number of intubation attempts, Cormack-Lehane grade of glottic view, incidence of complications related to intubation, difficulty experienced by the operator, patient's tolerability of the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-MAC videolaryngoscope | Active Comparator | Patients with anticipated difficult airway will be awake intubated with a C-MAC videolaryngoscopy. Spontaneous breathing will be preserved, and the same protocol of sedation plus upper airways topical anesthesia will be applied in both groups. |
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| Airtraq videolaryngoscope | Active Comparator | Patients with anticipated difficult airway will be awake intubated with a Airtraq videolaryngoscopy. Spontaneous breathing will be preserved, and the same protocol of sedation plus upper airways topical anesthesia will be applied in both groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-MAC videolaryngoscope | Device | Patients with anticipated difficult airway will be awake intubated with a C-MAC videolaryngoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the first attempt intubation success rate (percentage) | To compare the difference in the first attempt success rate (percentage) of different awake videolaryngoscope techniques for tracheal intubation. | during intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the overall success rate (percentage) | To compare the difference overall success rate (percentage) with the two awake videolaryngoscope techniques for tracheal intubation. | during intubation |
| Number of intubation attempts |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Santiago de Compostela | A Coruña | 15866 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29687891 | Background | Alhomary M, Ramadan E, Curran E, Walsh SR. Videolaryngoscopy vs. fibreoptic bronchoscopy for awake tracheal intubation: a systematic review and meta-analysis. Anaesthesia. 2018 Sep;73(9):1151-1161. doi: 10.1111/anae.14299. Epub 2018 Apr 17. | |
| 27844477 | Background | Lewis SR, Butler AR, Parker J, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adult patients requiring tracheal intubation. Cochrane Database Syst Rev. 2016 Nov 15;11(11):CD011136. doi: 10.1002/14651858.CD011136.pub2. |
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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 Types 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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| Airtraq videolaryngoscope. | Device | Patients with anticipated difficult airway will be awake intubated with a Airtraq videolaryngoscopy |
|
To compare number of intubations attempts with the two awake videolaryngoscope techniques.
| during intubation |
| Cormack-Lehane grade of glottic view | To compare Cormack-Lehane grade of glottic view with the two awake videolaryngoscope techniques for tracheal intubation. | during intubation |
| Difference in the incidence of complications related to intubation (percentage) | To compare the difference in complications (percentage) with the two awake videolaryngoscope techniques. 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 esophageal intubation pulmonary aspiration, dental injuries Oral-pharynx and larynx traumatism | Participants will be followed from the beginning of the intervention to 30 minutes after the intervention |
| Degree of subjective difficulty experienced by the operator | 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 |
| Degree of subjective patient's tolerability of the procedure | Operator-assessed subjective patient's tolerance of the procedure by means of a special analogue numerical scale from 0 to 10, where 0=very good subjective tolerance and 10=very bad subjective tolerance | during intubation |
| Degree of patient's confort of the procedure | During the postoperative visit on the following day (24 hours after intubation), patient will be asked to rate their confort during the procedure by means of a special analogue numerical scale from 0 to 10, where 0=very good tolerance and 10=worst possible discomfort | 24 hours after intubation |
| 31356364 | Background | Moore A, Schricker T. Awake videolaryngoscopy versus fiberoptic bronchoscopy. Curr Opin Anaesthesiol. 2019 Dec;32(6):764-768. doi: 10.1097/ACO.0000000000000771. |
| 22321077 | Background | Moore AR, Schricker T, Court O. Awake videolaryngoscopy-assisted tracheal intubation of the morbidly obese. Anaesthesia. 2012 Mar;67(3):232-5. doi: 10.1111/j.1365-2044.2011.06979.x. |