Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-09 @ 8:30 AM
Study NCT ID:
NCT01908218
Status:
COMPLETED
Last Update Posted:
2013-07-25
First Post:
2013-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Reliability and Validity of the Upper Lip Bite Test to Predict Difficult Laryngoscopy in Korean
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-22', 'studyFirstSubmitDate': '2013-07-17', 'studyFirstSubmitQcDate': '2013-07-22', 'lastUpdatePostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cormack and Lehane grade', 'timeFrame': 'glottis view with direct laryngoscopy for 1 minute during anesthesia induction', 'description': 'When the patients undergoing general anesthesia with orotracheal intubation, after obtained glottis view with direct laryngoscopy, the performer assessed Cormack and Lehane grade. (It takes about 1 minutes). A grade 1 and 2 were rated as an easy laryngoscopy. Difficult laryngoscopy was defined as the inability to visualize the vocal cords, each includes Grades 3 and 4.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ULBT, diffficult laryngoscopy, Predictive Value of Tests'], 'conditions': ['Orotracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '30630419', 'type': 'DERIVED', 'citation': 'Kim JC, Ki Y, Kim J, Ahn SW. Ethnic considerations in the upper lip bite test: the reliability and validity of the upper lip bite test in predicting difficult laryngoscopy in Koreans. BMC Anesthesiol. 2019 Jan 10;19(1):9. doi: 10.1186/s12871-018-0675-5.'}]}, 'descriptionModule': {'briefSummary': 'Anticipated difficulties at laryngoscopy give time to prepare alternative method and proper management.\n\nSeveral methods to evaluate the anatomical structures has been used during preoperative period for airway assessment.\n\nEvaluation methods are such as the Mallampati classification, mouth opening, thyromental distance and sternocostal distance.\n\nthe Upper Lip Bite test, evaluates the possibility of a patient cover the mucosa of the upper lip by the lower incisor.\n\nThe aim of this study was to assess the clinical usefulness of the Upper Lip Bite test(ULBT) in Korean compared to Modified Mallampati classification(MMT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients undergoing general anesthesia with orotracheal intubation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients undergoing general anesthesia with orotracheal intubation\n\nExclusion Criteria:\n\n* patient who have facial anomaly , 2. patients who required a rapid sequence induction'}, 'identificationModule': {'nctId': 'NCT01908218', 'briefTitle': 'The Reliability and Validity of the Upper Lip Bite Test to Predict Difficult Laryngoscopy in Korean', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2008-0583'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ULBT group', 'description': '344 adult patients undergoing general anesthesia with orotracheal intubation'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Kwandong university colloge of medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}