Thyroid SurgeryNCT05251194
The Effect of McGrath Video Laryngoscope on the Glottic View at Thyroid Surgery Position
A study testing video laryngoscope at thyroid surgical position in people with Thyroid Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thyroid Surgery
- What is being tested?
- video laryngoscope at thyroid surgical position
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Mar 2022to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients schedule to thyroid surgery
Who cannot join
- disagree to participate
- patients with weak teeth
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Surgery
- Being tested
- video laryngoscope at thyroid surgical position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video laryngoscope at thyroid surgical positionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: video laryngoscope at thyroid surgical position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start25 Mar 2022
- Primary completion23 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jung-Man Lee, Seoul National University Hospital
- Investigators
- Jung-Man Lee, MD.PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251194
- Sponsor's protocol ID
- 20-2022-3
- Status last verified
- Mar 2023
- First submitted
- 11 Feb 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of McGrath Video Laryngoscope on the Glottic View at Thyroid Surgery Position in Tracheal Intubation
- ClinicalTrials.gov ID
- NCT05251194
- Acronym / sponsor ID
- 20-2022-3
- Conditions
- Thyroid Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| video laryngoscope at thyroid surgical position | Experimental | Device: video laryngoscope at thyroid surgical positionAfter 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients schedule to thyroid surgery
Key exclusion criteria (2 listed)
- disagree to participate
- patients with weak teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video laryngoscope at thyroid surgical positionAfter 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. | Device | video laryngoscope at thyroid surgical position |
Primary outcome
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Man Lee, MD.PhD principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video laryngoscope at thyroid surgical position in people with Thyroid Surgery, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
direct modified Cormack-Lehane grade without external manipulation (time frame: at tracheal intubation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.