Clinical trial NCT06842082: The Videolaryngoscopy Versus Direct Laringoscopy for Residents Intubation 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intubation Intratracheal
Airway Management
Keywords: Intubation
anesthesia residents
videolaryngoscope
direct laryngoscope
Lead sponsor: Hospital Universitario Lucus Augusti
Sponsor class: OTHER
Collaborators: name: Hospital Clinico Universitario de Santiago
name: Complexo Hospitalario de Ourense
name: Complejo Hospitalario Universitario de Pontevedra
name: Complexo Hospitalario Universitario de A Coruña
name: Complejo Hospitalario Universitario de Vigo
name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain)
First posted: 2025-02-24
Enrollment: 1008
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Laryngoscope Group: anesthesia resident intubation with Macintosh standard laryngoscope .

Videolaryngoscope Group: anesthesia resident intubation with videolaryngoscope Mac-Style Blade.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in the first attempt success rate (percentage)
timeFrame: During intubation
Secondary outcomes:
measure: Comparing the glottic view in the modified Cormack-Lehane scale between the two approaches
timeFrame: During intubation
measure: Difference in percentage of "easy intubation"
timeFrame: During intubation
measure: Duration of laryngoscopy and tracheal intubation
timeFrame: During intubation
measure: Number of attempts to cannulate the trachea with an endotracheal tube
timeFrame: During intubation
measure: Number of attempts to cannulate the trachea with a bougie.
timeFrame: During intubation
measure: Need to change the device for intubation
timeFrame: During intubation
measure: Need for additional airway equipment
timeFrame: During intubation
measure: Operator-assessed difficulty of intubation
timeFrame: During intubation
measure: Use of external laryngeal pressure
timeFrame: During intubation
measure: Reason for failure to intubate on the first attempt
timeFrame: During intubation
measure: Complications during intubation
timeFrame: Participants will be followed from the beginning of the intervention to 10 minutes after the intervention
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Hospital Universitario de Ferrol
state: A Coruña
city: Santiago
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: A Coruña
city: Vigo
country: Spain
facility: Complejo Hospitalario Alvaro Cunqueiro Vigo
state: Pontevedra
city: Vigo
country: Spain
facility: Hospital POVISA de Vigo
state: Pontevedra
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario de A Coruña
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Pontevedra
country: Spain
facility: Complexo Hospitalario de Pontevedra
Study officials:
affiliation: Hospital Universitario Lucus Augusti
name: María Bermúdez María Bermúdez López, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.