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

NCT05428995 | Completed

• 1 other identifier: AWAKE-CMAC-AIRTRAQ
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation

Keywords

intubation; difficult airway; videolaryngoscope

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Difference in the overall success rate (percentage)

  during intubation

• Number of intubation attempts

  during intubation

• Cormack-Lehane grade of glottic view

  during intubation

• 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

• Degree of subjective difficulty experienced by the operator

  during intubation

Study Arms (2)

C-MAC videolaryngoscope

ACTIVE COMPARATOR

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

Airtraq videolaryngoscope

ACTIVE COMPARATOR

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.

Interventions

C-MAC videolaryngoscope DEVICE

Patients with anticipated difficult airway will be awake intubated with a C-MAC videolaryngoscopy

C-MAC videolaryngoscope

Airtraq videolaryngoscope. DEVICE

Patients with anticipated difficult airway will be awake intubated with a Airtraq videolaryngoscopy

Airtraq videolaryngoscope

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Patients with anticipated difficult airway requiring awake intubation under local anaesthesia and conscious sedation for general anesthesia.

You may not qualify if:

• Pregnancy
• age \<18 years
• refusal of the patient
• patient's respiratory failure

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead

Study Sites (1)

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, 15866, Spain

Location

Related Publications (4)

• 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.

  PMID: 29687891 BACKGROUND

• 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.

  PMID: 27844477 BACKGROUND

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

  PMID: 31356364 BACKGROUND

• 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.

  PMID: 22321077 BACKGROUND

Study Officials

• Manuel Taboada Muñiz, Ph.D.

  University Clinical Hospital of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor University Of Santiago de Compostela

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 23, 2022
• Study Start: June 15, 2022
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: January 23, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: When available: With publication
• Access Criteria: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose

Locations

ES (1)