Comparison of Two Videolaryngoscopes (C-MAC vs Airtraq) for Awake Intubation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Comparison Between the C-MAC and Airtraq Videolaryngoscopes for First-attempt Intubation Success in Awake Patients With Anticipated Difficult Airway.

Conditions
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Intubation

Intervention / Treatment
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* Device: C-MAC videolaryngoscope
* Device: Airtraq videolaryngoscope.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C-MAC videolaryngoscope<br>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<br>* Patients with anticipated difficult airway will be awake intubated with a C-MAC videolaryngoscopy<br>|
| Active Comparator: Airtraq videolaryngoscope<br>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.<br>* Patients with anticipated difficult airway will be awake intubated with a Airtraq videolaryngoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubation, difficult airway, videolaryngoscope