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Improvement of the Glottic View by Video Laryngoscope

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ClinicalTrials.gov Identifier: NCT04620434
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : November 17, 2021
Sponsor:
Collaborator:
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Dongwook Won, Seoul National University Hospital

Study Description
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Brief Summary:
This study aims to compare the exposure of glottis by the use of video and direct laryngoscopy.

Condition or disease Intervention/treatment
Laryngoscope Intubation Laryngoscopy Device: Video laryngoscopic view Device: Direct laryngoscopic view

Detailed Description:
It is well known that a video laryngoscope can provide better glottic view than a direct laryngoscope. However, to date, a direct laryngoscope has been the standard equipment for tracheal intubation. Recently, it seems that use of the video laryngoscope has increased. However, the advantage of the video laryngoscope over a direct laryngoscope has not been measured quantitatively. In this study, the glottic view by the use of video laryngoscope will be compared with that of the direct laryngoscope simultaneously, by using C-MAC S-imager installed with a disposable Macintosh blade. Intubating anesthesiologists will use it as if it is a direct laryngoscope. Simultaneously, the glottic views visualized on the monitor of the video laryngoscope will be recorded and evaluated later. For quantitative comparison, the glottic view will be scored with the Percentage of glottic opening scale, for both direct laryngoscopy and video laryngoscopy. Also, the glottic view will be compared by Cormack-Lehane grade.
Study Design
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Study Type : Observational
Estimated Enrollment : 39 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Improvement of the Glottic View by the Use of Video Laryngoscope
Actual Study Start Date : June 23, 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
patient
39 patients who are planning surgeries that require general anesthesia and tracheal intubation
 Device: Video laryngoscopic view
The glottic view on the screen of the video laryngoscope during laryngoscopy with a C-MAC video laryngoscope, which installed with Macintosh blade.

Device: Direct laryngoscopic view
The glottic view evaluated by the anesthesiologist who performing tracheal intubation, by direct laryngoscopy with C-MAC installed with Macintosh blade.


Outcome Measures
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Primary Outcome Measures :
  1. POGO (Percentage of Glottic Opening) score [ Time Frame: during laryngoscopy ]
    POGO (Percentage of Glottic Opening) score of the glottic view by video/direct laryngoscope during laryngoscopy without external laryngeal manipulation. (Percentage of glottic opening score, which means a better outcome at higher score: linear span from the anterior commissure to the interarytenoid notch; 0%, only interarytenoid notch seen; 100% full view of vocal cords)

  2. Cormack-Lehane grade [ Time Frame: during laryngoscopy ]
    Cormack-Lehane grade with video/direct laryngoscope, during laryngoscopy without external laryngeal manipulation (Cormack-Lehane grade, which means a better outcome at lower score: grade 1, Full view of glottis; grade 2a, Partial view of glottis; grade 2b, Only posterior extremity of glottis or arytenoid cartilages; grade 3, Only epiglottis seen; grade 4, Neither glottis nor epiglottis seen)


Secondary Outcome Measures :
  1. POGO score with external laryngeal manipulation [ Time Frame: during laryngoscopy ]
    POGO score of the glottic view by video/direct laryngoscope during laryngoscopy with external laryngeal manipulation. (Percentage of glottic opening score, which means a better outcome at higher score: linear span from the anterior commissure to the interarytenoid notch; 0%, only interarytenoid notch seen; 100% full view of vocal cords)

  2. Cormack-Lehane grade with external laryngeal manipulation [ Time Frame: during laryngoscopy ]
    Cormack-Lehane grade with video/direct laryngoscope, during laryngoscopy with external laryngeal manipulation. (Cormack-Lehane grade, which means a better outcome at lower score: grade 1, Full view of glottis; grade 2a, Partial view of glottis; grade 2b, Only posterior extremity of glottis or arytenoid cartilages; grade 3, Only epiglottis seen; grade 4, Neither glottis nor epiglottis seen)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who have airways with various degrees of difficulty will be candidates for this observational study.
Criteria

Inclusion Criteria:

  • Patients who are over 18 years old, and are planning surgeries that require general anesthesia and tracheal intubation.

Exclusion Criteria:

  • Patients who are not agreed to participate in the trial
  • Patients who have a poor dental condition which requires other than direct laryngoscopy
  • Patients who require rapid sequence induction technique
  • Patients with cervical spine instability
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620434


Contacts
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Contact: Dongwook Won +82-2-870-2516 dngwkwn@gmail.com
Contact: Jung-Man Lee +82-2-870-2513 jungman007@gmail.com

Locations
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Korea, Republic of
SMG-SNU Recruiting
Seoul, Korea, Republic of, 07061
Sponsors and Collaborators
Seoul National University Hospital
SMG-SNU Boramae Medical Center
Investigators
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Principal Investigator: Dongwook Won SMG-SNU Boramae Medical Center
More Information
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Publications:

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Responsible Party: Dongwook Won, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04620434    
Other Study ID Numbers: 30-2020-25
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dongwook Won, Seoul National University Hospital:
Video laryngoscope
Glottis
Airway