Improvement of the Glottic View by Video Laryngoscope

Intubation Clinical Trial

Official title:

Improvement of the Glottic View by the Use of Video Laryngoscope

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04620434
• Other study ID #: 30-2020-25
• Status: Recruiting
• Start date: June 23, 2021
• Est. completion date: December 2021

Study information

• Verified date: November 2021
• Source: Seoul National University Hospital
• Contact: Dongwook Won
• Phone: +82-2-870-2516
• Email: dngwkwn[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intubation
• Laryngoscope
• Laryngoscopy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	SMG-SNU	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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