Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-02 @ 9:51 AM
Study NCT ID:
NCT05251194
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2022-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of McGrath Video Laryngoscope on the Glottic View at Thyroid Surgery Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2022-02-11', 'studyFirstSubmitQcDate': '2022-02-11', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'direct modified Cormack-Lehane grade without external manipulation', 'timeFrame': 'at tracheal intubation', 'description': 'During laryngoscopy, the modified Cormack-Lehane grade without external manipulation as if the laryngoscope is assumed as a direct laryngoscope'}, {'measure': 'direct percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) without external manipulation', 'timeFrame': 'at tracheal intubation', 'description': 'During laryngoscopy, the percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) without external manipulation as if the laryngoscope is assumed as a direct laryngoscope'}, {'measure': 'video modified Cormack-Lehane grade without external manipulation', 'timeFrame': 'at tracheal intubation', 'description': 'During laryngoscopy, the modified Cormack-Lehane grade without external manipulation as if the laryngoscope is used as a video laryngoscope'}, {'measure': 'video percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) without external manipulation', 'timeFrame': 'at tracheal intubation', 'description': 'During laryngoscopy, the percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) without external manipulation as if the laryngoscope is used as a video laryngoscope'}, {'measure': 'direct modified Cormack-Lehane grade with external manipulation', 'timeFrame': 'at tracheal intubation', 'description': 'During laryngoscopy, the modified Cormack-Lehane grade with external manipulation as if the laryngoscope is assumed as a direct laryngoscope'}, {'measure': 'direct percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) with external manipulation', 'timeFrame': 'at tracheal intubation', 'description': 'During laryngoscopy, the percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) with external manipulation as if the laryngoscope is assumed as a direct laryngoscope'}, {'measure': 'video modified Cormack-Lehane grade with external manipulation', 'timeFrame': 'at tracheal intubation', 'description': 'During laryngoscopy, the modified Cormack-Lehane grade with external manipulation as if the laryngoscope is used as a video laryngoscope'}, {'measure': 'video percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) with external manipulation', 'timeFrame': 'at tracheal intubation', 'description': 'During laryngoscopy, the percentage of glottic opening score (POGO score: 0 - 100, 100 means full visualization of vocal cords) with external manipulation as if the laryngoscope is used as a video laryngoscope'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Surgery']}, 'descriptionModule': {'briefSummary': "For thyroid surgery, the special body position (thyroid surgical position) to exposure the patient's neck should be needed. For intraoperative neuromonitoring (IONM) in thyroid surgery, the tube should be placed at a specific position. A video laryngoscope can have advantages in tracheal intubation on thyroid surgical position for thyroid surgery. The purpose of the study is to investigate the effect of McGrath video laryngoscope on the glottic view when tracheal intubation is performed at the thyroid surgical position.", 'detailedDescription': "For thyroid surgery, the special body position (thyroid surgical position) to exposure the patient's neck should be needed. Meanwhile, the tracheal tube can be moved in the trachea from the supine position to thyroid surgical position if tracheal intubation is performed at the supine position. For intraoperative neuromonitoring (IONM) in thyroid surgery, the electrode of the tracheal tube must be placed at a specific position, that is between the vocal cords. To perform initially tracheal intubation on the thyroid surgical position, therefore, can have advantage in terms of stability of tube position in the trachea without displacement by body position change. However, tracheal intubation on thyroid surgical position might be hard in terms of obtaining a good glottic view. It is well known that video laryngoscopes can improve the glottic view. Therefore, a video laryngoscope can have advantages in tracheal intubation on thyroid surgical position for thyroid surgery in obtaining the good glottic view as well as minimal displacement of the tracheal tube because there is no need to change the patient's position. The purpose of the study is to investigate the effect of McGrath video laryngoscope on the glottic view when tracheal intubation is performed at the thyroid surgical position."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients schedule to thyroid surgery\n\nExclusion Criteria:\n\n* disagree to participate\n* patients with weak teeth'}, 'identificationModule': {'nctId': 'NCT05251194', 'briefTitle': 'The Effect of McGrath Video Laryngoscope on the Glottic View at Thyroid Surgery Position', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of McGrath Video Laryngoscope on the Glottic View at Thyroid Surgery Position in Tracheal Intubation', 'orgStudyIdInfo': {'id': '20-2022-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'video laryngoscope at thyroid surgical position', 'description': 'After induction of anesthesia and muscle relaxation, the patient will be positioned with a standard pillow to exposure neck for thyroid surgery (thyroid surgical position). Then, tracheal intubation will be performed with a McGrath video laryngoscope. During laryngoscopy with the McGrath video laryngoscope, the intubation practitioner will record the modified Cormack-Lehane grade and the percentage of glottic opening (POGO) score when it is assumed that a direct laryngoscope is used and when using the video laryngoscope, respectively.\n\nNext, the intubation practitioner will perform tracheal intubation with it.', 'interventionNames': ['Device: video laryngoscope at thyroid surgical position']}], 'interventions': [{'name': 'video laryngoscope at thyroid surgical position', 'type': 'DEVICE', 'description': 'After induction of anesthesia and muscle relaxation, the patient will be positioned with a standard pillow to exposure neck for thyroid surgery (thyroid surgical position). Then, tracheal intubation will be performed with a McGrath video laryngoscope. During laryngoscopy with the McGrath video laryngoscope, the intubation practitioner will record the modified Cormack-Lehane grade and the percentage of glottic opening (POGO) score when it is assumed that a direct laryngoscope is used and when using the video laryngoscope, respectively.', 'armGroupLabels': ['video laryngoscope at thyroid surgical position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Metropolitan Government Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jung-Man Lee, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate professor', 'investigatorFullName': 'Jung-Man Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}