McGrath Video Laryngoscope for All Intubations in the Operating Room

Intubation Complication Clinical Trial

— VIDEO-SURG  

Official title:

Effect of Providing a Personal McGrath Video Laryngoscope to Anesthesiologists for All Intubations in the Operating Room: A Multicentre Prospective Observational, Before-after Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05850260
• Other study ID #: VIDEOLAR-SURGERY
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Hospital Clinico Universitario de Santiago
• Contact: Manuel Taboada Muñiz, M.D., Ph.D.
• Phone: 0034-981950674
• Email: manutabo[@]yahoo.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intubation Complication

Intervention

Device:
• 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
• 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.

Locations

Country	Name	City	State
Spain	Manuel Taboada	Santiago De Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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	Intubations at the first attempt	To compare difference in the incidence of intubations at the first attempt in the two periods studied. (percentage)	during intubation
Secondary	Number of intubations attempts	To compare number of intubations attempts in the two periods studied	during intubation
Secondary	Modified Cormack-Lehane grade of glottic view	To compare Modified Cormack-Lehane grade of glottic view in the two periods studied Modified Cormack-Lehane grade of glottic view:I: full view of the glottis IIa: partial view of the glottis IIb: arytenoid or posterior part of the vocal cords just visible III: only epiglottis visible IV: neither glottis nor epiglottis visible	during intubation
Secondary	Need of adjuvant airway devices for intubation	To compare need of adjuvant airway devices for intubation in the two periods studied airway devices for intubation: bougie, videolaryngoscope, others)	during intubation
Secondary	Operator-assessed subjective difficulty	To compare degree of subjective difficulty experienced by the operator in the two periods studied.; Subjective difficulty of intubation by means of a special analogue numerical scale from 0 to 10, where 0=no subjective difficulty and 10=maximal subjective difficulty	during intubation
Secondary	Complications during intubation	To compare percentage of complications associated with the intubation in the two periods studied	Participants will be followed from the beginning of the intervention to 30 minutes after the intervention
Secondary	Overall success rate intubation	To compare the difference overall success rate intubation (percentage) with the first device used in each period	During intubation
Secondary	Need to change the device for intubation	To compare the need to change the device for intubation in the two periods studied	During intubation