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

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation
• Intervention / Treatment: Device: C-MAC videolaryngoscope; Device: Airtraq videolaryngoscope.

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Taboada Muñiz, Ph.D.; Phone Number: 0034-981950674; Email: manutabo@yahoo.es
• Study Contact Backup: Name: Manuel Taboada Muñiz, Ph.D.; Phone Number: 0034-678195618; Email: manuel.taboada.muniz@sergas.es

Study Locations

• Spain
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15866
      • University Clinical Hospital of Santiago de Compostela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: C-MAC videolaryngoscope; Patients with anticipated difficult airway will be awake intubated with a C-MAC videolaryngoscopy
Active Comparator: 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.	Device: Airtraq videolaryngoscope.; Patients with anticipated difficult airway will be awake intubated with a Airtraq videolaryngoscopy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Clinico Universitario de Santiago
• Investigators: Principal Investigator: Manuel Taboada Muñiz, Ph.D., University Clinical Hospital of Santiago de Compostela

Publications and helpful links

General Publications

• Moore A, Schricker T. Awake videolaryngoscopy versus fiberoptic bronchoscopy. Curr Opin Anaesthesiol. 2019 Dec;32(6):764-768. doi: 10.1097/ACO.0000000000000771.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): January 19, 2024
• Study Completion (Actual): January 19, 2024

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: intubation; difficult airway; videolaryngoscope
• Other Study ID Numbers: AWAKE-CMAC-AIRTRAQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose Mechanisms of data availability: With investigator support
• IPD Sharing Time Frame: When available: With publication
• IPD Sharing Access Criteria: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No