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Intubation IntratrachealVILARE-AdultNCT06842082

The Videolaryngoscopy Versus Direct Laringoscopy for Residents Intubation Study

A study testing Intubation with standard laryngoscope and Intubation with video laryngoscope in people with Intubation Intratracheal and Airway Management, run by Hospital Universitario Lucus Augusti at 9 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intubation Intratracheal, Airway Management
What is being tested?
Intubation with standard laryngoscope and Intubation with video laryngoscope
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,008 participants
Where
9 sitesSpain
Study dates
16 Jun 2025to 24 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Spain9 sites

  • Complejo Hospitalario Universitario de A Coruña

    A Coruña, A Coruña

  • Hospital Universitario de Ferrol

    Ferrol, A Coruña

  • Hospital Universitario Lucus Agusti

    Lugo, Lugo, 27003

  • Hospital Universitario de La Princesa

    Madrid, Madrid

  • Complexo Hospitalario Universitario de Ourense

    Ourense, Ourense

  • Complexo Hospitalario de Pontevedra

    Pontevedra, Pontevedra

  • Complejo Hospitalario Universitario de Santiago

    Santiago, A Coruña

  • Complejo Hospitalario Alvaro Cunqueiro Vigo

    Vigo, Pontevedra

  • Hospital POVISA de Vigo

    Vigo, Pontevedra

Other trials in Spain

About this study

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

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.

Read more

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.
Read the detailed description

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.

Being tested
Intubation with standard laryngoscope, Intubation with video laryngoscope
Keywords
Intubation, anesthesia residents, videolaryngoscope, direct laryngoscope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intubation with standard laryngoscopeDevice

    Anesthesia resident will intubate using a standard laryngoscope.

  • Intubation with video laryngoscopeDevice

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

Study groups in NCT06842082
Study groupRoleWhat they receive
Laryngoscope GroupActive comparatorFor patients assigned to the Laryngoscope Group, the operator will use a Macintosh laryngoscope for the first laryngoscopy attempt
Receives: Device: Intubation with standard laryngoscope
Videolaryngoscope GroupActive comparatorFor patients assigned to the Videolaryngoscope Group, the operator will use a videolaryngoscope with Mac-Style Blade for the first laryngoscopy attempt
Receives: Device: Intubation with video laryngoscope

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: During intubation

Secondary outcomes (11)

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

    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

    Measured: During intubation

  2. Difference in percentage of "easy 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.

    Measured: During intubation

  3. Duration of laryngoscopy and tracheal 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.

    Measured: During intubation

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

    Number of attempts to cannulate the trachea with an endotracheal tube

    Measured: During intubation

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

    Number of attempts to cannulate the trachea with a bougie

    Measured: During intubation

  6. Need to change the device for intubation

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

    Measured: During intubation

  7. Need for additional airway equipment

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

    Measured: During intubation

  8. Operator-assessed difficulty of intubation

    Operator-assessed difficulty of intubation

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

    Measured: During intubation

  9. Use of external laryngeal pressure

    External laryngeal pressure: Sellick maneuver or BURP

    Measured: During intubation

  10. Reason for failure to intubate on the first attempt

    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

    Measured: During intubation

  11. Complications during intubation

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start16 Jun 2025
  3. Primary completion3 Mar 2026
  4. Study completion24 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Laryngoscope Group: anesthesia resident intubation with Macintosh standard laryngoscope . Videolaryngoscope Group: anesthesia resident intubation with videolaryngoscope Mac-Style Blade.
Masking
Single blind
Who is masked
Participant
Enrolment
1,008 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06842082
Sponsor's protocol ID
VILARE-Adults-Study
Acronym
VILARE-Adult
Status last verified
Jun 2025
First submitted
10 Feb 2025
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu ZJ, Yi J, Guo WJ, Ma C, Huang YG. Comparison of McGrath Series 3 and Macintosh Laryngoscopes for Tracheal Intubation in Patients With Normal Airway by Inexperienced Anesthetists: A Randomized Study. Medicine (Baltimore). 2016 Jan;95(2):e2514. doi: 10.1097/MD.0000000000002514.

    PubMed 26765472

  • Taboada M, Estany-Gestal A, Rial M, Carinena A, Martinez A, Selas S, Eiras M, Veiras S, Ferreiroa E, Cardalda B, Lopez C, Calvo A, Fernandez J, Alvarez J, Alcantara JM, Seoane-Pillado T. Impact of Universal Use of the McGrath Videolaryngoscope as a Device for All Intubations in the Cardiac Operating Room. A Prospective Before-After VIDEOLAR-CAR Study. J Cardiothorac Vasc Anesth. 2024 Jul;38(7):1499-1505. doi: 10.1053/j.jvca.2024.03.016. Epub 2024 Mar 15.

    PubMed 38580479

  • Yamamoto Y, Kimura S, Kuniyoshi H, Hiroe T, Terui T, Kase Y. Novice residents' endotracheal intubation skill retention on a simulated mannequin after rotating at an anaesthesiology department: a randomized controlled study. J Int Med Res. 2023 Oct;51(10):3000605231206313. doi: 10.1177/03000605231206313.

    PubMed 37848388

  • Taboada M, Bermudez M, Fernandez J, Estany-Gestal A, Amate JJ, Ruido R, Amor M, Mato R, Barreiro C, Martinez P, Ramasco F, Vazquez O, Seoane-Pillado T. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation by anesthesia residents in the operating room: The randomized multicenter VILARE trial protocol. Rev Esp Anestesiol Reanim (Engl Ed). 2026 Feb;73(2):501988. doi: 10.1016/j.redare.2026.501988. Epub 2026 Jan 12.

    PubMed 41534770

Questions about this trial

What is this clinical trial studying?

A study testing Intubation with standard laryngoscope and Intubation with video laryngoscope in people with Intubation Intratracheal and Airway Management, run by Hospital Universitario Lucus Augusti at 9 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the first attempt success rate (percentage) (time frame: During intubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06842082, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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