VIDEO-SURG: McGrath Video Laryngoscope for All Intubations in the Operating Room

Sponsor
Hospital Clinico Universitario de Santiago (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05850260
Collaborator
(none)
5,200
19

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Macintosh laryngoscope
  • Device: Videolaryngoscope

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
5200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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
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

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.

Outcome Measures

Primary Outcome Measures

  1. "easy intubation" [during 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)

Secondary Outcome Measures

  1. Intubations at the first attempt [during intubation]

    To compare difference in the incidence of intubations at the first attempt in the two periods studied. (percentage)

  2. Number of intubations attempts [during intubation]

    To compare number of intubations attempts in the two periods studied

  3. Modified Cormack-Lehane grade of glottic view [during intubation]

    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

  4. Need of adjuvant airway devices for intubation [during intubation]

    To compare need of adjuvant airway devices for intubation in the two periods studied airway devices for intubation: bougie, videolaryngoscope, others)

  5. Operator-assessed subjective difficulty [during intubation]

    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

  6. Complications during intubation [Participants will be followed from the beginning of the intervention to 30 minutes after the intervention]

    To compare percentage of complications associated with the intubation in the two periods studied

  7. Overall success rate intubation [During intubation]

    To compare the difference overall success rate intubation (percentage) with the first device used in each period

  8. Need to change the device for intubation [During intubation]

    To compare the need to change the device for intubation in the two periods studied

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospital Clinico Universitario de Santiago

Investigators

  • Principal Investigator: Manuel Taboada Muñiz, M.D., Ph.D., University Clinical Hospital of Santiago de Compostela

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Manuel Taboada Muñiz, Associate Profesor, Hospital Clinico Universitario de Santiago
ClinicalTrials.gov Identifier:
NCT05850260
Other Study ID Numbers:
  • VIDEOLAR-SURGERY
First Posted:
May 9, 2023
Last Update Posted:
May 9, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Manuel Taboada Muñiz, Associate Profesor, Hospital Clinico Universitario de Santiago

Study Results

No Results Posted as of May 9, 2023