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

H

Hospital Universitario Lucus Augusti

Status

Enrolling

Conditions

Intubation Intratracheal
Airway Management

Treatments

Device: Intubation with standard laryngoscope
Device: Intubation with video laryngoscope

Study type

Interventional

Funder types

Other

Identifiers

NCT06842082
VILARE-Adults-Study

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,008 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,008 participants in 2 patient groups

Laryngoscope Group
Active Comparator group
Description:
For patients assigned to the Laryngoscope Group, the operator will use a Macintosh laryngoscope for the first laryngoscopy attempt
Treatment:
Device: Intubation with standard laryngoscope
Videolaryngoscope Group
Active Comparator group
Description:
For patients assigned to the Videolaryngoscope Group, the operator will use a videolaryngoscope with Mac-Style Blade for the first laryngoscopy attempt
Treatment:
Device: Intubation with video laryngoscope

Trial contacts and locations

9

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Central trial contact

Manuel Taboada Manuel Taboada Muñiz, MD, PhD; Maria Bermúdez María Bermúdez López, Medical Doctor

Data sourced from clinicaltrials.gov

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