Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-25 @ 3:13 PM
Study NCT ID:
NCT05128968
Status:
COMPLETED
Last Update Posted:
2022-12-29
First Post:
2021-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Head and Neck Positions for Endotracheal Intubation Using a Videolaryngoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-28', 'studyFirstSubmitDate': '2021-11-11', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ease of intubation', 'timeFrame': 'Procedure (During endotracheal intubation)', 'description': 'Ease of endotracheal intubation is assessed using the intubation difficulty scale.\n\nIntubation difficulty scale includes number of attempts, number of operators, number of alternative techniques, glottic opening and so on.'}], 'secondaryOutcomes': [{'measure': 'Percentage of glottic opening (POGO) score', 'timeFrame': 'Procedure (During endotracheal intubation)', 'description': 'POGO score is recorded during endotracheal intubation (0%: no visualization of glottic opening; 100%: entire visualization of the glottic opening).'}, {'measure': 'Number of attempts', 'timeFrame': 'Procedure (At the end of endotracheal intubation)', 'description': 'Number of attempts for endotracheal intubation is recorded.'}, {'measure': 'Intubation time', 'timeFrame': 'Procedure (During endotracheal intubation)', 'description': 'The time taken for endotracheal intubation is recorded.'}, {'measure': 'Palatopharyngeal wall injury', 'timeFrame': 'Procedure (During endotracheal intubation)', 'description': 'Presence of palatopharyngeal wall injury is observed.'}, {'measure': 'Lifting force for exposure of the glottis', 'timeFrame': 'Procedure (During endotracheal intubation)', 'description': 'Requirement for lifting force to expose the glottis is recorded during videolaryngoscopy'}, {'measure': 'Laryngeal pressure for exposure of the glottis', 'timeFrame': 'Procedure (During endotracheal intubation)', 'description': 'Requirement for laryngeal force to expose the glottis is recorded during videolaryngoscopy'}, {'measure': 'Lifting force for advancing an endotracheal tube into the larynx', 'timeFrame': 'Procedure (During endotracheal intubation)', 'description': 'Requirement for lifting force is recorded during the advancement of the endotracheal tube into the larynx.'}, {'measure': 'Laryngeal pressure for advancing an endotracheal tube into the larynx.', 'timeFrame': 'Procedure (During endotracheal intubation)', 'description': 'Requirement for laryngeal pressure is recorded during the advancement of the endotracheal tube into the larynx.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endotracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '37052067', 'type': 'DERIVED', 'citation': 'Kim H, Chang JE, Won D, Lee JM, Kim TK, Kim MJ, Min SW, Hwang JY. Effect of head and neck positions on tracheal intubation using a McGRATH MAC video laryngoscope: A randomised, prospective study. Eur J Anaesthesiol. 2023 Aug 1;40(8):560-567. doi: 10.1097/EJA.0000000000001838. Epub 2023 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators evaluate the effect of head positions (simple extension vs. sniffing position vs. head elevation) on endotracheal intubation using a videolaryngoscope.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for general anesthesia\n\nExclusion Criteria:\n\n* Limited neck extension\n* Anatomical anomalies or history of surgery in the upper airway\n* Weak teeth\n* Risk of pulmonary aspiration'}, 'identificationModule': {'nctId': 'NCT05128968', 'briefTitle': 'Head and Neck Positions for Endotracheal Intubation Using a Videolaryngoscope', 'organization': {'class': 'OTHER', 'fullName': 'SMG-SNU Boramae Medical Center'}, 'officialTitle': 'Impact of Head and Neck Positions on Endotracheal Intubation Using a McGRATH MAC Video Laryngoscope', 'orgStudyIdInfo': {'id': '11-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simple extension', 'description': 'After induction of anesthesia, endotracheal intubation was performed in simple extension without a pillow using a McGrath MAC videolaryngoscope.', 'interventionNames': ['Procedure: endotracheal intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Head elevated position', 'description': 'After induction of anesthesia, endotracheal intubation was performed in a head elevated position with a pillow using a McGrath MAC videolaryngoscope.', 'interventionNames': ['Procedure: endotracheal intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Sniffing position', 'description': 'After induction of anesthesia, endotracheal intubation was performed in a sniffing position using a McGrath MAC videolaryngoscope.', 'interventionNames': ['Procedure: endotracheal intubation']}], 'interventions': [{'name': 'endotracheal intubation', 'type': 'PROCEDURE', 'description': 'Endotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope.', 'armGroupLabels': ['Head elevated position', 'Simple extension', 'Sniffing position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Metropolitan Government Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Young Hwang, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Young Hwang', 'investigatorAffiliation': 'SMG-SNU Boramae Medical Center'}}}}