AWAKECMACTRA: Comparison of Two Videolaryngoscopes (C-MAC vs Airtraq) for Awake Intubation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: C-MAC videolaryngoscope 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. |
Device: C-MAC videolaryngoscope
Patients with anticipated difficult airway will be awake intubated with a C-MAC videolaryngoscopy
|
| Active Comparator: Airtraq videolaryngoscope 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. |
Device: Airtraq videolaryngoscope.
Patients with anticipated difficult airway will be awake intubated with a Airtraq videolaryngoscopy
|
Outcome Measures
Primary Outcome Measures
- Difference in the first attempt intubation success rate (percentage) [during intubation]
To compare the difference in the first attempt success rate (percentage) of different awake videolaryngoscope techniques for tracheal intubation.
Secondary Outcome Measures
- Difference in the overall success rate (percentage) [during intubation]
To compare the difference overall success rate (percentage) with the two awake videolaryngoscope techniques for tracheal intubation.
- Number of intubation attempts [during intubation]
To compare number of intubations attempts with the two awake videolaryngoscope techniques.
- Cormack-Lehane grade of glottic view [during intubation]
To compare Cormack-Lehane grade of glottic view with the two awake videolaryngoscope techniques for tracheal intubation.
- Difference in the incidence of complications related to intubation (percentage) [Participants will be followed from the beginning of the intervention to 30 minutes after the intervention]
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
- Degree of subjective difficulty experienced by the operator [during 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
- Degree of subjective patient's tolerability of the procedure [during intubation]
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
- Degree of patient's confort of the procedure [24 hours after intubation]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years and older
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Patients with anticipated difficult airway requiring awake intubation under local anaesthesia and conscious sedation for general anesthesia.
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Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.
Exclusion Criteria:
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Pregnancy
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age <18 years
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refusal of the patient
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patient's respiratory failure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Clinical Hospital of Santiago de Compostela | Santiago de Compostela | A Coruña | Spain | 15866 |
Sponsors and Collaborators
- Hospital Clinico Universitario de Santiago
Investigators
- Principal Investigator: Manuel Taboada Muñiz, Ph.D., University Clinical Hospital of Santiago de Compostela
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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:CD011136. Review. Update in: Cochrane Database Syst Rev. 2022 Apr 4;4:CD011136.
- Moore A, Schricker T. Awake videolaryngoscopy versus fiberoptic bronchoscopy. Curr Opin Anaesthesiol. 2019 Dec;32(6):764-768. doi: 10.1097/ACO.0000000000000771. Review.
- 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.
- AWAKE-CMAC-AIRTRAQ