Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT02944305
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2016-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Predictive Model for Difficult Intubation
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2016-10-24', 'studyFirstSubmitQcDate': '2016-10-24', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difficult intubation', 'timeFrame': '5 minutes', 'description': 'Laryngoscopic view: grade 1-2 = no difficult intubation; grade 3-4 = difficult intubation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Difficult Intubation']}, 'referencesModule': {'references': [{'pmid': '9416711', 'type': 'RESULT', 'citation': 'Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.'}, {'pmid': '11207469', 'type': 'RESULT', 'citation': 'Adnet F, Racine SX, Borron SW, Clemessy JL, Fournier JL, Lapostolle F, Cupa M. A survey of tracheal intubation difficulty in the operating room: a prospective observational study. Acta Anaesthesiol Scand. 2001 Mar;45(3):327-32. doi: 10.1034/j.1399-6576.2001.045003327.x.'}, {'pmid': '26004598', 'type': 'RESULT', 'citation': 'Aktas S, Atalay YO, Tugrul M. Predictive value of bedside tests for difficult intubations. Eur Rev Med Pharmacol Sci. 2015;19(9):1595-9.'}, {'pmid': '12553386', 'type': 'RESULT', 'citation': 'Iohom G, Ronayne M, Cunningham AJ. Prediction of difficult tracheal intubation. Eur J Anaesthesiol. 2003 Jan;20(1):31-6. doi: 10.1017/s0265021503000061.'}, {'pmid': '15171524', 'type': 'RESULT', 'citation': 'Merah NA, Foulkes-Crabbe DJ, Kushimo OT, Ajayi PA. Prediction of difficult laryngoscopy in a population of Nigerian obstetric patients. West Afr J Med. 2004 Jan-Mar;23(1):38-41. doi: 10.4314/wajm.v23i1.28079.'}]}, 'descriptionModule': {'briefSummary': 'Failure in airway management is one of the most common anesthesia-related morbidity and mortality. Each individual airway assessment has limitation to predict difficult intubation.', 'detailedDescription': 'Objective: To develop a scoring model from multiple airway assessment to predict difficult intubation.\n\nMethods: This will be a retrospective analytic study. All airway assessment data from medical records of patients aged more than 18 years old underwent general anesthesia in Srinagarind hospital from January 2012 to December 2014 will be used to develop a new scoring prediction model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing general anesthesia with endotracheal intubation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing general anesthesia with endotracheal intubation\n\nExclusion Criteria:\n\n* Incomplete airway assessment in medical record'}, 'identificationModule': {'nctId': 'NCT02944305', 'briefTitle': 'A Predictive Model for Difficult Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'A New Prognostic Model Developed by Using Multi-predictive Tests for Prediction of Difficult Intubation in Adult Anesthetic Patients', 'orgStudyIdInfo': {'id': 'HE581149'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with difficult intubation', 'description': 'Group 1: Patient undergoing endotracheal intubation with difficult intubation Group 2: Patient undergoing endotracheal intubation without difficult intubation', 'interventionNames': ['Procedure: Endotracheal intubation']}], 'interventions': [{'name': 'Endotracheal intubation', 'type': 'PROCEDURE', 'description': 'Endotracheal intubation under direct laryngoscopy using McIntosh blade', 'armGroupLabels': ['Patient with difficult intubation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'state': 'Changwat Khon Kaen', 'country': 'Thailand', 'facility': 'Srinagarind Hospital, Faculty of Medicine, Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Sirirat Tribuddharat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Thepakorn Sathitkarnmanee', 'investigatorAffiliation': 'Khon Kaen University'}}}}