NCT05251194

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

February 11, 2022

Last Update Submit

March 29, 2023

Conditions

Outcome Measures

Primary Outcomes (8)

  • direct modified Cormack-Lehane grade without external manipulation

    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

    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

    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

    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

    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

    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

    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

    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

Study Arms (1)

video laryngoscope at thyroid surgical position

EXPERIMENTAL

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

Interventions

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.

video laryngoscope at thyroid surgical position

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients schedule to thyroid surgery

You may not qualify if:

  • disagree to participate
  • patients with weak teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Study Officials

  • Jung-Man Lee, MD.PhD

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate professor

Study Record Dates

First Submitted

February 11, 2022

First Posted

February 22, 2022

Study Start

March 25, 2022

Primary Completion

May 23, 2022

Study Completion

May 31, 2022

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations