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

Not Applicable

Completed

• Conditions: Intubation
• Interventions: Device: C-MAC videolaryngoscope; Device: Airtraq videolaryngoscope.

• Registration Number: NCT05428995
• Lead Sponsor: Hospital Clinico Universitario de Santiago

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.

Study Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Status Verified: 2023-07
• Primary Completion: 2024-01-19
• Study Completion: 2024-01-19
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C-MAC videolaryngoscope	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.
Airtraq videolaryngoscope	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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 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
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
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.

Trial Locations

Locations (1)

University Clinical Hospital of Santiago de Compostela; 🇪🇸 Santiago de Compostela, A Coruña, Spain