The Videolaryngoscopy Versus Direct Laringoscopy for Residents Intubation Study (VILARE-Adult)

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.

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.

Study Overview

• Status: Completed
• Conditions: Airway Management; Intubation Intratracheal
• Intervention / Treatment: Device: Intubation with standard laryngoscope; Device: Intubation with video laryngoscope

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.

• Study Type: Interventional
• Enrollment (Actual): 1008
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • A Coruña
    • A Coruña, A Coruña, Spain
      • Complejo Hospitalario Universitario de A Coruña
    • Ferrol, A Coruña, Spain
      • Hospital Universitario de Ferrol
    • Santiago, A Coruña, Spain
      • Complejo Hospitalario Universitario de Santiago
  • Lugo
    • Lugo, Lugo, Spain, 27003
      • Hospital Universitario Lucus Agustí
  • Madrid
    • Madrid, Madrid, Spain
      • Hospital Universitario de La Princesa
  • Ourense
    • Ourense, Ourense, Spain
      • Complexo Hospitalario Universitario de Ourense
  • Pontevedra
    • Pontevedra, Pontevedra, Spain
      • Complexo Hospitalario de Pontevedra
    • Vigo, Pontevedra, Spain
      • Complejo Hospitalario Alvaro Cunqueiro Vigo
    • Vigo, Pontevedra, Spain
      • Hospital POVISA de Vigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laryngoscope Group; For patients assigned to the Laryngoscope Group, the operator will use a Macintosh laryngoscope for the first laryngoscopy attempt	Device: Intubation with standard laryngoscope; Anesthesia resident will intubate using a standard laryngoscope.
Active Comparator: Videolaryngoscope Group; For patients assigned to the Videolaryngoscope Group, the operator will use a videolaryngoscope with Mac-Style Blade for the first laryngoscopy attempt	Device: Intubation with video laryngoscope; Anesthesia resident will intubate using a videolaryngoscope (Storz C-MAC, McGrath, Glidescope or other videolaryngoscope)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During intubation
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.	During intubation
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.	During intubation
Number of attempts to cannulate the trachea with an endotracheal tube	Number of attempts to cannulate the trachea with an endotracheal tube	During intubation
Number of attempts to cannulate the trachea with a bougie.	Number of attempts to cannulate the trachea with a bougie	During intubation
Need to change the device for intubation	Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope...	During intubation
Need for additional airway equipment	Airway equipment: bougie, stylet, other videolaryngoscope, others.	During intubation
Operator-assessed difficulty of intubation	Operator-assessed difficulty of intubation; without difficulty; mild difficulty; moderate difficulty; severe difficulty	During intubation
Use of external laryngeal pressure	External laryngeal pressure: Sellick maneuver or BURP	During intubation
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	During intubation
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.	Participants will be followed from the beginning of the intervention to 10 minutes after the intervention

Collaborators and Investigators

• Sponsor: Hospital Universitario Lucus Augusti
• Collaborators: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa; Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain); Complexo Hospitalario Universitario de A Coruña; Hospital Clinico Universitario de Santiago; Complejo Hospitalario Universitario de Vigo; Complejo Hospitalario Universitario de Pontevedra; Complexo Hospitalario de Ourense
• Investigators: Principal Investigator: María Bermúdez María Bermúdez López, MD, Hospital Universitario Lucus Augusti

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Actual): March 3, 2026
• Study Completion (Actual): March 24, 2026

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Intubation; videolaryngoscope; direct laryngoscope; anesthesia residents
• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Intubation
• Other Study ID Numbers: VILARE-Adults-Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No