Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-28 @ 12:06 AM
Study NCT ID:
NCT04620434
Status:
UNKNOWN
Last Update Posted:
2021-11-17
First Post:
2020-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of the Glottic View by Video Laryngoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'POGO (Percentage of Glottic Opening) score', 'timeFrame': 'during laryngoscopy', 'description': '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)'}, {'measure': 'Cormack-Lehane grade', 'timeFrame': 'during laryngoscopy', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'POGO score with external laryngeal manipulation', 'timeFrame': 'during laryngoscopy', 'description': '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)'}, {'measure': 'Cormack-Lehane grade with external laryngeal manipulation', 'timeFrame': 'during laryngoscopy', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Video laryngoscope', 'Glottis', 'Airway'], 'conditions': ['Laryngoscope', 'Intubation', 'Laryngoscopy']}, 'referencesModule': {'references': [{'pmid': '29576112', 'type': 'BACKGROUND', 'citation': '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': '16905081', 'type': 'BACKGROUND', '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. doi: 10.1016/j.jclinane.2006.01.002.'}, {'pmid': '9754506', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1553-2712.1998.tb02823.x.'}, {'pmid': '6507827', 'type': 'BACKGROUND', 'citation': 'Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the exposure of glottis by the use of video and direct laryngoscopy.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have airways with various degrees of difficulty will be candidates for this observational study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are over 18 years old, and are planning surgeries that require general anesthesia and tracheal intubation.\n\nExclusion Criteria:\n\n* Patients who are not agreed to participate in the trial\n* Patients who have a poor dental condition which requires other than direct laryngoscopy\n* Patients who require rapid sequence induction technique\n* Patients with cervical spine instability'}, 'identificationModule': {'nctId': 'NCT04620434', 'briefTitle': 'Improvement of the Glottic View by Video Laryngoscope', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Improvement of the Glottic View by the Use of Video Laryngoscope', 'orgStudyIdInfo': {'id': '30-2020-25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient', 'description': '39 patients who are planning surgeries that require general anesthesia and tracheal intubation', 'interventionNames': ['Device: Video laryngoscopic view', 'Device: Direct laryngoscopic view']}], 'interventions': [{'name': 'Video laryngoscopic view', 'type': 'DEVICE', 'description': 'The glottic view on the screen of the video laryngoscope during laryngoscopy with a C-MAC video laryngoscope, which installed with Macintosh blade.', 'armGroupLabels': ['patient']}, {'name': 'Direct laryngoscopic view', 'type': 'DEVICE', 'description': 'The glottic view evaluated by the anesthesiologist who performing tracheal intubation, by direct laryngoscopy with C-MAC installed with Macintosh blade.', 'armGroupLabels': ['patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07061', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'SMG-SNU', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Dongwook Won', 'role': 'CONTACT', 'email': 'dngwkwn@gmail.com', 'phone': '+82-2-870-2516'}, {'name': 'Jung-Man Lee', 'role': 'CONTACT', 'email': 'jungman007@gmail.com', 'phone': '+82-2-870-2513'}], 'overallOfficials': [{'name': 'Dongwook Won', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Dongwook Won', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}