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Completed

NCT Number: NCT05428995

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

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.

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Key information

Conditions

Intubation

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, 15866, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C-MAC videolaryngoscope

Device

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

Airtraq videolaryngoscope.

Device

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

Primary outcomes

  1. 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

  1. Difference in the overall success rate (percentage)

    Time frame: during intubation

    To compare the difference overall success rate (percentage) with the two awake videolaryngoscope techniques for tracheal intubation.

  2. Number of intubation attempts

    Time frame: during intubation

    To compare number of intubations attempts with the two awake videolaryngoscope techniques.

  3. Cormack-Lehane grade of glottic view

    Time frame: during intubation

    To compare Cormack-Lehane grade of glottic view with the two awake videolaryngoscope techniques for tracheal intubation.

  4. Difference in the incidence of complications related to intubation (percentage)

    Time frame: 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

  5. Degree of subjective difficulty experienced by the operator

    Time frame: 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

  6. Degree of subjective patient's tolerability of the procedure

    Time frame: 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

  7. Degree of patient's confort of the procedure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital Clinico Universitario de Santiago

Other

Registry information

Official study title

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

Acronym: AWAKECMACTRA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2022
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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