NCT04620434

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

June 23, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

November 3, 2020

Last Update Submit

November 15, 2021

Conditions

LaryngoscopeIntubationLaryngoscopy

Keywords

Video laryngoscopeGlottisAirway

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • POGO score with external laryngeal manipulation

    during laryngoscopy

  • Cormack-Lehane grade with external laryngeal manipulation

    during laryngoscopy

Study Arms (1)

patient

39 patients who are planning surgeries that require general anesthesia and tracheal intubation

Device: Video laryngoscopic viewDevice: Direct laryngoscopic view

Interventions

Video laryngoscopic viewDEVICE

The glottic view on the screen of the video laryngoscope during laryngoscopy with a C-MAC video laryngoscope, which installed with Macintosh blade.

patient
Direct laryngoscopic viewDEVICE

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

patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU

Seoul, 07061, South Korea

RECRUITING

Related 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.

    PMID: 29576112BACKGROUND

  • 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.

    PMID: 16905081BACKGROUND

  • 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.

    PMID: 9754506BACKGROUND

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

    PMID: 6507827BACKGROUND

Study Officials

  • Dongwook Won

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongwook Won

CONTACT

+82-2-870-2516dngwkwn@gmail.com

Jung-Man Lee

CONTACT

+82-2-870-2513jungman007@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 9, 2020

Study Start

June 23, 2021

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

November 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)