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Completed

NCT Number: NCT05522049

Videolaryngoscopic Intubation Using Macintosh vs.Hyperangulated Blades in Patients With Expected Difficult Intubation

Videolaryngoscopy-guided intubation has become widespread as a means of preventing major complications relating to airway management by improving the glottic view, increasing the first attempt success rate, likely reduce rates of hypoxemic events, while reducing the rate of airway trauma. However, as randomized controlled studies in patients with anticipated difficult intubation undergoing ear nose and throat (ENT) or oral and maxillofacial (OMF) surgery are lacking, it is still unknown if hyperangulated blades improve glottic view and if their use translates into faster intubation. The primary aim of this randomized controlled trial is to compare the percentage of glottic opening (POGO) between hyperangulated blades and Macintosh blades in patients with expected difficult intubation undergoing ENT or OMF surgery who require transoral tracheal intubation. Secondary aims are to compare secondary outcome measures such as time variables, indicators for difficult and successful intubation, number of attempts, view conditions, difficult airway classifications and adverse events between both blade types.

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Key information

Conditions

Intubation; Difficult or Failed General Anesthesia Videolaryngoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients requiring general anesthesia with transoral tracheal intubation for elective ear, nose and throat or maxillofacial surgery
  • Expected difficult intubation
  • Age ≥ 18

Exclusion criteria

  • Pregnant or breastfeeding woman
  • Planned awake tracheal intubation (without deep anesthesia or neuromuscular blocking agents)
  • Required transnasal tracheal intubation (e.g. for surgical reasons)
  • Special tubes required for surgical reasons ( e.g. double lumen tube)
  • Denial of consent

Treatment and study plan

hyperangulated videolaryngoscope

Device

Intubation using a hyperangulated videolaryngoscope

Other names: C-MAC D-Blade, Storz

Macintosh videolaryngoscope

Device

Intubation using a Macintosh videolaryngoscope

Other names: C-MAC, Storz

Primary outcomes

  1. Percentage of glottic opening (POGO)

    Time frame: 1 hour

    Grading of the best view obtained during laryngoscopy (%)

Secondary outcomes

  1. Time to successful tracheal intubation (seconds)

    Time frame: 1 hour

    Recorded during airway management

  2. Time to successful first attempt intubation (seconds)

    Time frame: 1 hour

    Recorded during airway management

  3. Cormack-Lehane grade

    Time frame: 1 hour

    Grading of the best view obtained during laryngoscopy (I [best] to IV [worst])

  4. Impaired view (vocal cords cannot be visualized by laryngoscopy)

    Time frame: 1 hour

    Number of participants with impaired view observed during airway management

  5. Difficult laryngoscopy

    Time frame: 1 hour

    Number of participants with difficult laryngoscopy as defined in current guidelines

  6. Difficult intubation

    Time frame: 1 hour

    Number of participants with difficult tracheal intubation as defined in current guidelines

  7. Transition to a different tracheal intubation technique

    Time frame: 1 hour

    Number of participants in whom the airway operator decided to convert to an alternative intubation technique

  8. Tracheal introducer

    Time frame: 1 hour

    Number of participants in whom the airway operator decided to use a tracheal introducer

  9. Successful first attempt

    Time frame: 1 hour

    Number of participants with successful tracheal intubation with only one attempt

  10. Overall success of intubation

    Time frame: 1 hour

    Number of participants with successful tracheal intubation regardless of the the number of attempts

  11. Difficulty of videolaryngoscope-guided intubation

    Time frame: 1 hour

    VIDIAC (Videolaryngoscopic Intubation and Difficult Airway Classification) Score from -1 (best) to 5 (worst)

  12. Number of intubation attempts

    Time frame: 1 hour

    Observed during airway management

  13. Number of laryngoscopy attempts

    Time frame: 1 hour

    Observed during airway management

  14. Airway related adverse events

    Time frame: 1 hour

    Number of participants with airway related adverse events observed during airway management

  15. Hypoxaemia

    Time frame: 1 hour

    Number of participants with a drop in peripheral oxygen saturation during airway management

  16. Hypotension

    Time frame: 1 hour

    Number of participants with hypotension observed during airway management

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Videolaryngoscopy-guided Intubation Using Macintosh Versus Hyperangulated Blades in Patients With Expected Difficult Intubation Undergoing Ear, Nose and Throat Surgery or Maxillofacial Surgery a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2022
Registry last updated
Sep 26, 2023

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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