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Completed

NCT Number: NCT06842082

The Videolaryngoscopy Versus Direct Laringoscopy for Residents Intubation Study

The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. However, this skill is not easy to acquire and requires adecuate training. Videolaryngoscopes are becoming a widely accepted airway management technique. because offer better view of the glottis and are easy to use. In addition, indirect laryngoscopes are useful for tracheal intubation by novice operators because of the feedback that supervisors can offer during intubation.

The goal of this clinical trial is to learn which intubation technique performed by residents of anesthesia in the operating room is better.

The main questions it aims to answer are:

* Which intubation technique is more effective for achieving first-attempt intubation? * Which intubation technique results in fewer complications? Researchers will compare both intubation techniques performed by anesthesia residents in the operating room in adult anesthesia cases.

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Key information

Conditions

Intubation Intratracheal Airway Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain

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About this study

The study will randomize, by means of a computer-generated randomization, approximately 1008 adults in two groups: Conventional group (Laryngoscope with Macintosh Blade) and Videolaryngoscope group (Mac-Style Blade) to be intubated in the operating room by an anesthesia resident.

Success rate of the selected technique (first attempt), overall success rate, number of attempts, complications, and duration of insertion for technique will be noted.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥18 years old
  • Patients who need to be tracheal intubated for a surgical intervention in the surgical area.
  • Intubation performed by an anesthesia resident.

Exclusion criteria

  • Need for tracheal intubation with a device other than videolaryngoscopy or direct laryngoscopy (fiberoptic bronchoscope, tracheostomy...).
  • Context of a Difficult Airway Management.
  • Refusal of the patient

Treatment and study plan

Intubation with standard laryngoscope

Device

Anesthesia resident will intubate using a standard laryngoscope.

Intubation with video laryngoscope

Device

Anesthesia resident will intubate using a videolaryngoscope (Storz C-MAC, McGrath, Glidescope or other videolaryngoscope)

Primary outcomes

  1. Difference in the first attempt success rate (percentage)

    Time frame: During intubation

    Success on the first attempt is defined as successfully passing the tube through the vocal cords in a single laryngoscopy attempt and inserting the endotracheal tube into the trachea

Secondary outcomes

  1. Comparing the glottic view in the modified Cormack-Lehane scale between the two approaches

    Time frame: During intubation

    Modified Cormack-Lehane grade of glottic view:

    • I: full view of the glottis
    • IIa: partial view of the glottis
    • IIb: arytenoid or the posterior part of the vocal cords just visible
    • III: only epiglottis visible
    • IV: neither glottis nor epiglottis visible Cormack-Lehane grade of glottic view

  2. Difference in percentage of "easy intubation"

    Time frame: During intubation

    To compare the difference in "easy intubation," defined as a Cormack-Lehane grade I-IIa glottic view and successful intubation on the first attempt, between the two intubation approaches.

  3. Duration of laryngoscopy and tracheal intubation

    Time frame: During intubation

    The interval (in seconds) between the first insertion of a laryngoscope blade into the mouth and the final placement of a tube in the trachea.

  4. Number of attempts to cannulate the trachea with an endotracheal tube

    Time frame: During intubation

    Number of attempts to cannulate the trachea with an endotracheal tube

  5. Number of attempts to cannulate the trachea with a bougie.

    Time frame: During intubation

    Number of attempts to cannulate the trachea with a bougie

  6. Need to change the device for intubation

    Time frame: During intubation

    Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope...

  7. Need for additional airway equipment

    Time frame: During intubation

    Airway equipment: bougie, stylet, other videolaryngoscope, others.

  8. Operator-assessed difficulty of intubation

    Time frame: During intubation

    Operator-assessed difficulty of intubation

    • without difficulty
    • mild difficulty
    • moderate difficulty
    • severe difficulty

  9. Use of external laryngeal pressure

    Time frame: During intubation

    External laryngeal pressure: Sellick maneuver or BURP

  10. Reason for failure to intubate on the first attempt

    Time frame: During intubation

    Reason for failure among those who did not meet the primary outcome (successful intubation on the first attempt):

    • Inadequate view of the larynx
    • Inability to intubate the trachea with an endotracheal tube
    • Inability to cannulate the trachea with a bougie
    • Attempt aborted due to change in patient condition (e.g., worsening hypoxemia, hypotension, bradycardia, vomiting, bleeding)
    • Technical failure of the laryngoscope (e.g., battery, light source, camera, screen)
    • Other

  11. Complications during intubation

    Time frame: Participants will be followed from the beginning of the intervention to 10 minutes after the intervention

    Complications during the procedure and within the following 10 minutes, including: hypotension (SBP < 80 mmHg), hypotension (SBP < 65 mmHg), O₂ saturation < 90%, O₂ saturation < 80%, bronchoaspiration, esophageal intubation, dental injury, airway injury, and others.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Lucus Augusti

Other

Collaborators

  • Complejo Hospitalario Universitario de Pontevedra
  • Complejo Hospitalario Universitario de Vigo
  • Complexo Hospitalario Universitario de A Coruña
  • Complexo Hospitalario de Ourense
  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
  • Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain)
  • Hospital Clinico Universitario de Santiago

Registry information

Official study title

A Multicenter, Prospective, Randomized, Single-blind Study Comparing Direct Laryngoscopy and Videolaryngoscopy for Orotracheal Intubation Performed by Anesthesia Residents in the Operating Room

Acronym: VILARE-Adult

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2025
Registry last updated
Mar 25, 2026

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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