McGrath Video Laryngoscope for All Intubations in the Operating Room

NCT ID: NCT05850260

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-09-30

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.

Detailed Description

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 personal 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.

The VIDEOLAR-SURGERY trial is a prospective, observational, open-label, multicenter study, with before-after analysis. Consecutive patients requiring tracheal intubation for an elective o urgent surgical intervention from a period of 14 months by one of the 35 researcher's anesthesiologists assigned will be recruited. In the pre-implementation period (6 months), the 35 anesthesiologists will perform all tracheal intubations using the standard Macintosh direct laryngoscope as a first intubation option. During the implementation period (2 months), a personal McGrath videolaryngoscope will be provided to each anesthesiologist to train in its use. During the post-implementation period (6 months), the 35 anesthesiologists will perform all tracheal intubations using their personal McGrath Mac videolaryngoscope as a first intubation option. The main objective is to evaluate whether the use of a own McGrath videolaryngoscope by anesthesiologists, as the first intubation option, improves the percentage of patients with easy intubation compared with the standard Macintosh laryngoscope. Secondary objectives are to compare incidence of first-attempt intubation, laryngoscopic vision, need of adjuvant airway devices, difficulty, and complications.

Conditions

Intubation Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Macintosh laryngoscope

Intervention Type: 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

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

Videolaryngoscope

Intervention Type: 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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinico Universitario de Santiago

OTHER

Sponsor Role: lead

Responsible Party

Manuel Taboada Muñiz

Associate Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manuel Taboada Muñiz, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Clinical Hospital of Santiago de Compostela

Locations

Manuel Taboada

Santiago de Compostela, A Coruña, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 35820934 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35811139 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29397126 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29397120 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39542091 (View on PubMed)

Other Identifiers

VIDEOLAR-SURGERY

Identifier Type: -

Identifier Source: org_study_id