Improvement of the Glottic View by Video Laryngoscope

Improvement of the Glottic View by the Use of Video Laryngoscope

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

Study Overview

• Status: Recruiting
• Conditions: Intubation; Laryngoscopy; Laryngoscope
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 39

Contacts and Locations

• Study Contact: Name: Dongwook Won; Phone Number: +82-2-870-2516; Email: dngwkwn@gmail.com
• Study Contact Backup: Name: Jung-Man Lee; Phone Number: +82-2-870-2513; Email: jungman007@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07061
    • Recruiting
    • SMG-SNU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who have airways with various degrees of difficulty will be candidates for this observational study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POGO (Percentage of Glottic Opening) score	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)	during laryngoscopy
Cormack-Lehane grade	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)	during laryngoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POGO score with external laryngeal manipulation	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)	during laryngoscopy
Cormack-Lehane grade with external laryngeal manipulation	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)	during laryngoscopy

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: SMG-SNU Boramae Medical Center
• Investigators: Principal Investigator: Dongwook Won, SMG-SNU Boramae Medical Center

Publications and helpful links

General Publications

• Arulkumaran N, Lowe J, Ions R, Mendoza M, Bennett V, Dunser MW. Videolaryngoscopy versus direct laryngoscopy for emergency orotracheal intubation outside the operating room: a systematic review and meta-analysis. Br J Anaesth. 2018 Apr;120(4):712-724. doi: 10.1016/j.bja.2017.12.041. Epub 2018 Feb 26.
• Kaplan MB, Hagberg CA, Ward DS, Brambrink A, Chhibber AK, Heidegger T, Lozada L, Ovassapian A, Parsons D, Ramsay J, Wilhelm W, Zwissler B, Gerig HJ, Hofstetter C, Karan S, Kreisler N, Pousman RM, Thierbach A, Wrobel M, Berci G. Comparison of direct and video-assisted views of the larynx during routine intubation. J Clin Anesth. 2006 Aug;18(5):357-62. doi: 10.1016/j.jclinane.2006.01.002.
• Levitan RM, Ochroch EA, Kush S, Shofer FS, Hollander JE. Assessment of airway visualization: validation of the percentage of glottic opening (POGO) scale. Acad Emerg Med. 1998 Sep;5(9):919-23. doi: 10.1111/j.1553-2712.1998.tb02823.x.
• Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 23, 2021
• Primary Completion (ANTICIPATED): November 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (ACTUAL): November 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Airway; Video laryngoscope; Glottis
• Other Study ID Numbers: 30-2020-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No