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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Patients with anticipated difficult airway will be awake intubated with a C-MAC videolaryngoscopy
Patients with anticipated difficult airway will be awake intubated with a Airtraq videolaryngoscopy
University Clinical Hospital of Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
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.
Time frame: during intubation
Difference in the overall success rate (percentage)
To compare the difference overall success rate (percentage) with the two awake videolaryngoscope techniques for tracheal intubation.
Time frame: during intubation
Number of intubation attempts
To compare number of intubations attempts with the two awake videolaryngoscope techniques.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 hours after intubation
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