McGrath Video Laryngoscope for All Intubations in the Operating Room

NCT05850260 | Completed

• 1 other identifier: VIDEOLAR-SURGERY
• Study Type: observational
• Target: 5,220
• Locations: 1 country
• Sites: 1

Brief Summary

Tracheal intubation is a very common procedure performed in the operating room. The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. Although in most patients there are no complications during intubation, more than 90% of difficult tracheal intubations in the operate room are unpredictable, and several authors, recommend the universal use of the videolaryngoscope for all intubations, using as the first intubation option regardless of whether the patient has predictors of a difficult airway or no.The authors do not know whether providing a own videolaryngoscope to each anesthesiologist to use as the first option for intubation in all patients who need it in the operating room improves the percentage of patients with easy intubation and decrease the incidence of complications.

Conditions

Intubation Complication

Keywords

diificult intubation; videolaryngoscope; airway

Outcome Measures

Primary Outcomes (1)

• "easy intubation"

  To compare "easy intubation" in the two study periods. "Easy intubation" defined as intubation at the first attempt, modified Cormack-Lehane grades of I or IIa and absence of need of adjuvant airway devices for intubation. (percentage)

  during intubation

Secondary Outcomes (8)

• Intubations at the first attempt

  during intubation

• Number of intubations attempts

  during intubation

• Modified Cormack-Lehane grade of glottic view

  during intubation

• Need of adjuvant airway devices for intubation

  during intubation

• Operator-assessed subjective difficulty

  during intubation

Study Arms (2)

Macintosh laryngoscope

During the pre-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations in the operation room according to the standard of care using the standard Macintosh direct laryngoscope as a first intubation option

Device: Macintosh laryngoscope

McGrath Mac videolaryngoscope

During the post-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations using their personal McGrath Mac videolaryngoscope as a first intubation option

Device: Videolaryngoscope

Interventions

Macintosh laryngoscope DEVICE

During the pre-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations in the operation room according to the standard of care using the standard Macintosh direct laryngoscope as a first intubation option

Macintosh laryngoscope

Videolaryngoscope DEVICE

During the post-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations using their personal McGrath Mac videolaryngoscope as a first intubation option.

McGrath Mac videolaryngoscope

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients who need to be tracheal intubated for an elective o urgent surgical intervention from a period of 14 months by one of the 35 anesthesiologists assigned by the Anesthesiology Services of the 8 Hospitals.

You may qualify if:

• years and older
• Patients who need to be tracheal intubated for a surgical intervention in the surgical area.

You may not qualify if:

• Patients who are intubated in a place other than the surgical area (Intensive Care, Emergency, Hospitalization floor) will not be included.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead

Study Sites (1)

Manuel Taboada

Santiago de Compostela, A Coruña, 15866, Spain

Location

Related Publications (5)

• Hansel J, Rogers AM, Lewis SR, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adults undergoing tracheal intubation: a Cochrane systematic review and meta-analysis update. Br J Anaesth. 2022 Oct;129(4):612-623. doi: 10.1016/j.bja.2022.05.027. Epub 2022 Jul 9.

  PMID: 35820934 BACKGROUND

• De Jong A, Sfara T, Pouzeratte Y, Pensier J, Rolle A, Chanques G, Jaber S. Videolaryngoscopy as a first-intention technique for tracheal intubation in unselected surgical patients: a before and after observational study. Br J Anaesth. 2022 Oct;129(4):624-634. doi: 10.1016/j.bja.2022.05.030. Epub 2022 Jul 8.

  PMID: 35811139 BACKGROUND

• Cook TM, Boniface NJ, Seller C, Hughes J, Damen C, MacDonald L, Kelly FE. Universal videolaryngoscopy: a structured approach to conversion to videolaryngoscopy for all intubations in an anaesthetic and intensive care department. Br J Anaesth. 2018 Jan;120(1):173-180. doi: 10.1016/j.bja.2017.11.014. Epub 2017 Nov 21.

  PMID: 29397126 BACKGROUND

• Cooper RM. Implementing universal videolaryngoscopy: how to do it and what to expect. Br J Anaesth. 2018 Jan;120(1):13-15. doi: 10.1016/j.bja.2017.11.017. Epub 2017 Nov 21. No abstract available.

  PMID: 29397120 BACKGROUND

• Taboada M, Estany-Gestal A, Rama-Maceiras P, Orallo MA, Bermudez M, Barreiro C, Gomez L, Amor M, Otero F, Fernandez J, Molins N, Amate JJ, Bascuas B, Rey R, Alonso MC, Castro MJ, Sarmiento A, Dos Santos L, Nieto C, Paredes S, Velasco A, Taboada C, Martin L, Campana D, Mosquera E, Novoa C, Varela S, da Silva L, Dominguez E, Bedoya A, Gomez AI, Estevez M, Martinez P, Sotojove R, Naveiro A, Diaz C, Ruido R, Miron P, Gonzalez M, Francisco C, Regueira J, Peiteado M, Eiras M, Paz E. Impact of universal use of the McGrath videolaryngoscope as the first option for all intubations in the operating room: The multicentre prospective before-after VIDEOLAR-SURGERY study protocol. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Jan;72(1):101649. doi: 10.1016/j.redare.2024.101649. Epub 2024 Nov 12.

  PMID: 39542091 DERIVED

Study Officials

• Manuel Taboada Muñiz, M.D., Ph.D.

  University Clinical Hospital of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesor

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 9, 2023
• Study Start: June 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: When available: With publication
• Access Criteria: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose

Locations

ES (1)