NCT06842082

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,008

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 16, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2026

Completed
Last Updated

March 25, 2026

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

February 10, 2025

Last Update Submit

March 24, 2026

Conditions

Keywords

Intubationanesthesia residentsvideolaryngoscopedirect laryngoscope

Outcome Measures

Primary Outcomes (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

    During intubation

Secondary Outcomes (11)

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

    During intubation

  • Difference in percentage of "easy intubation"

    During intubation

  • Duration of laryngoscopy and tracheal intubation

    During intubation

  • Number of attempts to cannulate the trachea with an endotracheal tube

    During intubation

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

    During intubation

  • +6 more secondary outcomes

Study Arms (2)

Laryngoscope Group

ACTIVE COMPARATOR

For patients assigned to the Laryngoscope Group, the operator will use a Macintosh laryngoscope for the first laryngoscopy attempt

Device: Intubation with standard laryngoscope

Videolaryngoscope Group

ACTIVE COMPARATOR

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

Interventions

Anesthesia resident will intubate using a standard laryngoscope.

Laryngoscope Group

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

Videolaryngoscope Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Complejo Hospitalario Universitario de A Coruña

A Coruña, A Coruña, Spain

Location

Hospital Universitario de Ferrol

Ferrol, A Coruña, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago, A Coruña, Spain

Location

Hospital Universitario Lucus Agusti

Lugo, Lugo, 27003, Spain

Location

Hospital Universitario de La Princesa

Madrid, Madrid, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, Ourense, Spain

Location

Complexo Hospitalario de Pontevedra

Pontevedra, Pontevedra, Spain

Location

Complejo Hospitalario Alvaro Cunqueiro Vigo

Vigo, Pontevedra, Spain

Location

Hospital POVISA de Vigo

Vigo, Pontevedra, Spain

Location

Related Publications (4)

  • 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.

    PMID: 26765472BACKGROUND
  • 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.

    PMID: 38580479BACKGROUND
  • 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.

    PMID: 37848388BACKGROUND
  • 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.

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • María Bermúdez María Bermúdez López, MD

    Hospital Universitario Lucus Augusti

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Laryngoscope Group: anesthesia resident intubation with Macintosh standard laryngoscope . Videolaryngoscope Group: anesthesia resident intubation with videolaryngoscope Mac-Style Blade.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 24, 2025

Study Start

June 16, 2025

Primary Completion

March 3, 2026

Study Completion

March 24, 2026

Last Updated

March 25, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations