The Effect of McGrath Video Laryngoscope on the Glottic View at Thyroid Surgery Position

March 29, 2023 updated by: Jung-Man Lee, Seoul National University Hospital

The Effect of McGrath Video Laryngoscope on the Glottic View at Thyroid Surgery Position in Tracheal Intubation

For thyroid surgery, the special body position (thyroid surgical position) to exposure the patient's neck should be needed. For intraoperative neuromonitoring (IONM) in thyroid surgery, the tube should be placed at a specific position. A video laryngoscope can have advantages in tracheal intubation on thyroid surgical position for thyroid surgery. The purpose of the study is to investigate the effect of McGrath video laryngoscope on the glottic view when tracheal intubation is performed at the thyroid surgical position.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For thyroid surgery, the special body position (thyroid surgical position) to exposure the patient's neck should be needed. Meanwhile, the tracheal tube can be moved in the trachea from the supine position to thyroid surgical position if tracheal intubation is performed at the supine position. For intraoperative neuromonitoring (IONM) in thyroid surgery, the electrode of the tracheal tube must be placed at a specific position, that is between the vocal cords. To perform initially tracheal intubation on the thyroid surgical position, therefore, can have advantage in terms of stability of tube position in the trachea without displacement by body position change. However, tracheal intubation on thyroid surgical position might be hard in terms of obtaining a good glottic view. It is well known that video laryngoscopes can improve the glottic view. Therefore, a video laryngoscope can have advantages in tracheal intubation on thyroid surgical position for thyroid surgery in obtaining the good glottic view as well as minimal displacement of the tracheal tube because there is no need to change the patient's position. The purpose of the study is to investigate the effect of McGrath video laryngoscope on the glottic view when tracheal intubation is performed at the thyroid surgical position.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07061
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients schedule to thyroid surgery

Exclusion Criteria:

  • disagree to participate
  • patients with weak teeth

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: video laryngoscope at thyroid surgical position

After induction of anesthesia and muscle relaxation, the patient will be positioned with a standard pillow to exposure neck for thyroid surgery (thyroid surgical position). Then, tracheal intubation will be performed with a McGrath video laryngoscope. During laryngoscopy with the McGrath video laryngoscope, the intubation practitioner will record the modified Cormack-Lehane grade and the percentage of glottic opening (POGO) score when it is assumed that a direct laryngoscope is used and when using the video laryngoscope, respectively.

Next, the intubation practitioner will perform tracheal intubation with it.
Device: video laryngoscope at thyroid surgical position
After induction of anesthesia and muscle relaxation, the patient will be positioned with a standard pillow to exposure neck for thyroid surgery (thyroid surgical position). Then, tracheal intubation will be performed with a McGrath video laryngoscope. During laryngoscopy with the McGrath video laryngoscope, the intubation practitioner will record the modified Cormack-Lehane grade and the percentage of glottic opening (POGO) score when it is assumed that a direct laryngoscope is used and when using the video laryngoscope, respectively.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
direct modified Cormack-Lehane grade without external manipulation
Time Frame: at tracheal intubation
During laryngoscopy, the modified Cormack-Lehane grade without external manipulation as if the laryngoscope is assumed as a direct laryngoscope
at tracheal intubation
direct percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) without external manipulation
Time Frame: at tracheal intubation
During laryngoscopy, the percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) without external manipulation as if the laryngoscope is assumed as a direct laryngoscope
at tracheal intubation
video modified Cormack-Lehane grade without external manipulation
Time Frame: at tracheal intubation
During laryngoscopy, the modified Cormack-Lehane grade without external manipulation as if the laryngoscope is used as a video laryngoscope
at tracheal intubation
video percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) without external manipulation
Time Frame: at tracheal intubation
During laryngoscopy, the percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) without external manipulation as if the laryngoscope is used as a video laryngoscope
at tracheal intubation
direct modified Cormack-Lehane grade with external manipulation
Time Frame: at tracheal intubation
During laryngoscopy, the modified Cormack-Lehane grade with external manipulation as if the laryngoscope is assumed as a direct laryngoscope
at tracheal intubation
direct percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) with external manipulation
Time Frame: at tracheal intubation
During laryngoscopy, the percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) with external manipulation as if the laryngoscope is assumed as a direct laryngoscope
at tracheal intubation
video modified Cormack-Lehane grade with external manipulation
Time Frame: at tracheal intubation
During laryngoscopy, the modified Cormack-Lehane grade with external manipulation as if the laryngoscope is used as a video laryngoscope
at tracheal intubation
video percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) with external manipulation
Time Frame: at tracheal intubation
During laryngoscopy, the percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) with external manipulation as if the laryngoscope is used as a video laryngoscope
at tracheal intubation

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SMG-SNU Boramae Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jung-Man Lee, MD.PhD, SMG-SNU Boramae Medical Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-2022-3

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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