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Clinical Trials/NCT05428995
NCT05428995
Completed
Not Applicable

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

Hospital Clinico Universitario de Santiago1 site in 1 country90 target enrollmentJune 15, 2022
ConditionsIntubation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation
Sponsor
Hospital Clinico Universitario de Santiago
Enrollment
90
Locations
1
Primary Endpoint
Difference in the first attempt intubation success rate (percentage)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2022
End Date
January 19, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Manuel Taboada Muñiz

Professor University Of Santiago de Compostela

Hospital Clinico Universitario de Santiago

Eligibility Criteria

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

Outcomes

Primary Outcomes

Difference in the first attempt intubation success rate (percentage)

Time Frame: during intubation

To compare the difference in the first attempt success rate (percentage) of different awake videolaryngoscope techniques for tracheal intubation.

Secondary Outcomes

  • Degree of patient's confort of the procedure(24 hours after intubation)
  • Cormack-Lehane grade of glottic view(during intubation)
  • Degree of subjective patient's tolerability of the procedure(during intubation)
  • Degree of subjective difficulty experienced by the operator(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)
  • Difference in the overall success rate (percentage)(during intubation)
  • Number of intubation attempts(during intubation)

Study Sites (1)

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