Clinical trial NCT05428995: Comparison of Two Videolaryngoscopes (C-MAC vs Airtraq) for Awake Intubation
Official title: A Randomized Comparison Between the C-MAC and Airtraq Videolaryngoscopes for First-attempt Intubation Success in Awake Patients With Anticipated Difficult Airway.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Keywords: intubation
difficult airway
videolaryngoscope
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Patients with anticipated difficult airway requiring awake intubation under local anaesthesia and conscious sedation for general anesthesia.
* 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:

* Pregnancy
* age \<18 years
* refusal of the patient
* patient's respiratory failure

Primary outcomes:
measure: Difference in the first attempt intubation success rate (percentage)
timeFrame: during intubation
Secondary outcomes:
measure: Difference in the overall success rate (percentage)
timeFrame: during intubation
measure: Number of intubation attempts
timeFrame: during intubation
measure: Cormack-Lehane grade of glottic view
timeFrame: during intubation
measure: Difference in the incidence of complications related to intubation (percentage)
timeFrame: Participants will be followed from the beginning of the intervention to 30 minutes after the intervention
measure: Degree of subjective difficulty experienced by the operator
timeFrame: during intubation
measure: Degree of subjective patient's tolerability of the procedure
timeFrame: during intubation
measure: Degree of patient's confort of the procedure
timeFrame: 24 hours after intubation
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: University Clinical Hospital of Santiago de Compostela
state: A Coruña
Study officials:
affiliation: University Clinical Hospital of Santiago de Compostela
name: Manuel Taboada Muñiz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Moore A, Schricker T. Awake videolaryngoscopy versus fiberoptic bronchoscopy. Curr Opin Anaesthesiol. 2019 Dec;32(6):764-768. doi: 10.1097/ACO.0000000000000771.
citation: 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.