The Videolaryngoscopy Versus Direct Laringoscopy for Residents Intubation Study

NCT ID: NCT06842082

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1008 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-16

Study Completion Date

2025-12-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intubation Intratracheal Airway Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Laryngoscope Group: anesthesia resident intubation with Macintosh standard laryngoscope .

Videolaryngoscope Group: anesthesia resident intubation with videolaryngoscope Mac-Style Blade.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Laryngoscope Group

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

Group Type ACTIVE_COMPARATOR

Intubation with standard laryngoscope

Intervention Type DEVICE

Anesthesia resident will intubate using a standard laryngoscope.

Videolaryngoscope Group

For patients assigned to the Videolaryngoscope Group, the operator will use a videolaryngoscope with Mac-Style Blade for the first laryngoscopy attempt

Group Type ACTIVE_COMPARATOR

Intubation with video laryngoscope

Intervention Type DEVICE

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

Interventions

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Intubation with standard laryngoscope

Anesthesia resident will intubate using a standard laryngoscope.

Intervention Type DEVICE

Intubation with video laryngoscope

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinico Universitario de Santiago

OTHER

Sponsor Role collaborator

Complexo Hospitalario de Ourense

OTHER

Sponsor Role collaborator

Complejo Hospitalario Universitario de Pontevedra

OTHER

Sponsor Role collaborator

Complexo Hospitalario Universitario de A Coruña

OTHER

Sponsor Role collaborator

Complejo Hospitalario Universitario de Vigo

OTHER

Sponsor Role collaborator

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

OTHER

Sponsor Role collaborator

Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain)

UNKNOWN

Sponsor Role collaborator

Hospital Universitario Lucus Augusti

OTHER

Sponsor Role lead

Responsible Party

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Maria Bermudez Lopez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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María Bermúdez María Bermúdez López, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Lucus Augusti

Locations

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Complejo Hospitalario Universitario de A Coruña

A Coruña, A Coruña, Spain

Site Status RECRUITING

Hospital Universitario de Ferrol

Ferrol, A Coruña, Spain

Site Status RECRUITING

Complejo Hospitalario Universitario de Santiago

Santiago, A Coruña, Spain

Site Status RECRUITING

Hospital Universitario Lucus Agusti

Lugo, Lugo, Spain

Site Status RECRUITING

Hospital Universitario de La Princesa

Madrid, Madrid, Spain

Site Status ACTIVE_NOT_RECRUITING

Complexo Hospitalario Universitario de Ourense

Ourense, Ourense, Spain

Site Status RECRUITING

Complexo Hospitalario de Pontevedra

Pontevedra, Pontevedra, Spain

Site Status RECRUITING

Complejo Hospitalario Alvaro Cunqueiro Vigo

Vigo, Pontevedra, Spain

Site Status RECRUITING

Hospital POVISA de Vigo

Vigo, Pontevedra, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Maria Bermúdez María Bermúdez López, Medical Doctor

Role: CONTACT

+34 649766454

Manuel Taboada Manuel Taboada Muñiz, MD, PhD

Role: CONTACT

+34 98195000

Facility Contacts

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Nieves Nieves Molins Gauna, MD PhD

Role: primary

Fernando Otero

Role: primary

Manuel Taboada Manuel Taboada, MD PhD

Role: primary

+34 678195618

María Bermúdez López, MD

Role: primary

+34 649766454

Raquel Ruido Dacal

Role: primary

Cristina Barreiro Pardal

Role: primary

Juan José Amate Juan José Amate Pena

Role: primary

Marcos Amor Berdullas

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26765472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38580479 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37848388 (View on PubMed)

Other Identifiers

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VILARE-Adults-Study

Identifier Type: -

Identifier Source: org_study_id

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