Improvement of the Glottic View by Video Laryngoscope

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04620434
Collaborator
SMG-SNU Boramae Medical Center (Other)
39
1
5.3
7.4

Study Details

Study Description

Brief Summary

This study aims to compare the exposure of glottis by the use of video and direct laryngoscopy.

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Observational
Anticipated 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 :
Jun 23, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. POGO (Percentage of Glottic Opening) score [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 SMG-SNU Seoul Korea, Republic of 07061

Sponsors and Collaborators

  • Seoul National University Hospital
  • SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Dongwook Won, SMG-SNU Boramae Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dongwook Won, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04620434
Other Study ID Numbers:
  • 30-2020-25
First Posted:
Nov 9, 2020
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dongwook Won, Associate professor, Seoul National University Hospital

Study Results

No Results Posted as of Nov 17, 2021