LaryngoscopeNCT04620434
Improvement of the Glottic View by Video Laryngoscope
An observational study of Laryngoscope and Intubation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to compare the exposure of glottis by the use of video and direct laryngoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngoscope, Intubation, Laryngoscopy
- What is being tested?
- Video laryngoscopic view and Direct laryngoscopic view
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2021to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have airways with various degrees of difficulty will be candidates for this observational study.
Who may be able to join
- Patients who are over 18 years old, and are planning surgeries that require general anesthesia and tracheal intubation.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Laryngoscope, Intubation, Laryngoscopy
- Being tested
- Video laryngoscopic view, Direct laryngoscopic view
- Keywords
- Video laryngoscope, Glottis, Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Direct laryngoscopic viewDevice
The glottic view evaluated by the anesthesiologist who performing tracheal intubation, by direct laryngoscopy with C-MAC installed with Macintosh blade.
| Study group | Role | What they receive |
|---|---|---|
| patient | 39 patients who are planning surgeries that require general anesthesia and tracheal intubation Receives: Device: Video laryngoscopic view; Device: Direct laryngoscopic view |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: during laryngoscopy
Secondary outcomes (2)
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)
Measured: 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)
Measured: during laryngoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start23 Jun 2021
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LaryngoscopeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Dongwook Won, Seoul National University Hospital
- Investigators
- Dongwook Won, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620434
- Sponsor's protocol ID
- 30-2020-25
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2020
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29576112Kaplan 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.
PubMed 16905081Levitan 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.
PubMed 9754506Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
PubMed 6507827
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of the Glottic View by the Use of Video Laryngoscope
- ClinicalTrials.gov ID
- NCT04620434
- Acronym / sponsor ID
- 30-2020-25
- Conditions
- Laryngoscope, Intubation, Laryngoscopy
- Keywords
- Video laryngoscope, Glottis, Airway
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the exposure of glottis by the use of video and direct laryngoscopy.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | – | Device: Video laryngoscopic view, Device: Direct laryngoscopic view39 patients who are planning surgeries that require general anesthesia and tracheal intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have airways with various degrees of difficulty will be candidates for this observational study.
Key inclusion criteria (1 listed)
- Patients who are over 18 years old, and are planning surgeries that require general anesthesia and tracheal intubation.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video laryngoscopic viewThe glottic view on the screen of the video laryngoscope during laryngoscopy with a C-MAC video laryngoscope, which installed with Macintosh blade. | Device | patient |
| Direct laryngoscopic viewThe glottic view evaluated by the anesthesiologist who performing tracheal intubation, by direct laryngoscopy with C-MAC installed with Macintosh blade. | Device | patient |
Primary outcome
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)
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)
2 secondary outcomes
POGO score with external laryngeal manipulation
Time frame: during laryngoscopy
Cormack-Lehane grade with external laryngeal manipulation
Time frame: during laryngoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Background: PubMed 29576112Arulkumaran 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.
- Background: PubMed 16905081Kaplan 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.
- Background: PubMed 9754506Levitan 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.
- Background: PubMed 6507827Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongwook Won principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngoscope and Intubation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongwook Won (+82-2-870-2516, dngwkwn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POGO (Percentage of Glottic Opening) score (time frame: during laryngoscopy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04620434, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.