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

July 11, 2023 updated by: Manuel Taboada Muñiz, Hospital Clinico Universitario de Santiago

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

5200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Manuel Taboada Muñiz, M.D., Ph.D.
  • Phone Number: 0034-981950674
  • Email: manutabo@yahoo.es

Study Contact Backup

Study Locations

  • Spain
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15866

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"easy intubation"
Time Frame: 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)
during intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubations at the first attempt
Time Frame: during intubation
To compare difference in the incidence of intubations at the first attempt in the two periods studied. (percentage)
during intubation
Number of intubations attempts
Time Frame: during intubation
To compare number of intubations attempts in the two periods studied
during intubation
Modified Cormack-Lehane grade of glottic view
Time Frame: 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
during intubation
Need of adjuvant airway devices for intubation
Time Frame: during intubation
To compare need of adjuvant airway devices for intubation in the two periods studied airway devices for intubation: bougie, videolaryngoscope, others)
during intubation
Operator-assessed subjective difficulty
Time Frame: 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
during intubation
Complications during intubation
Time Frame: 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
Participants will be followed from the beginning of the intervention to 30 minutes after the intervention
Overall success rate intubation
Time Frame: During intubation
To compare the difference overall success rate intubation (percentage) with the first device used in each period
During intubation
Need to change the device for intubation
Time Frame: During intubation
To compare the need to change the device for intubation in the two periods studied
During intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinico Universitario de Santiago

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VIDEOLAR-SURGERY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data types: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose Mechanisms of data availability: With investigator support

IPD Sharing Time Frame

When available: With publication

IPD Sharing Access Criteria

Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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