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

Hospital Clinico Universitario de Santiago

Status: Completed

Conditions: Intubation

Treatments: Device: C-MAC videolaryngoscope; Device: Airtraq videolaryngoscope.

Study type: Interventional

Funder types: Other

Identifiers

NCT05428995

AWAKE-CMAC-AIRTRAQ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

C-MAC videolaryngoscope

Active Comparator group

Description:

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.

Treatment:

Device: C-MAC videolaryngoscope

Airtraq videolaryngoscope

Active Comparator group

Description:

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.

Treatment:

Device: Airtraq videolaryngoscope.