Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 5:35 PM
Study NCT ID:
NCT03950934
Status:
COMPLETED
Last Update Posted:
2020-05-29
First Post:
2019-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Videolaryngoscopic Intubation and Difficult Airway Classification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2019-05-13', 'studyFirstSubmitQcDate': '2019-05-14', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difficult videolaryngoscopic intubation', 'timeFrame': '30 minutes after endotracheal intubation', 'description': 'Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Successful first intubation attempt', 'timeFrame': '30 minutes after endotracheal intubation', 'description': 'Observation during airway management'}, {'measure': 'Overall success', 'timeFrame': '30 minutes after endotracheal intubation', 'description': 'Observation during airway management'}, {'measure': 'Unsuccessful videolaryngoscopy', 'timeFrame': '30 minutes after endotracheal intubation', 'description': 'Observation during airway management'}, {'measure': 'Severity of videolaryngoscopic intubation', 'timeFrame': '30 minutes after endotracheal intubation', 'description': 'Numeral rating scale'}, {'measure': 'Specific recommendations of the handling anesthetist', 'timeFrame': '30 minutes after endotracheal intubation', 'description': 'Questionnaire'}, {'measure': 'Time to successful intubation', 'timeFrame': '30 minutes after endotracheal intubation', 'description': 'Observation during airway management'}, {'measure': 'Number of laryngoscopy and intubation attempts', 'timeFrame': '30 minutes after endotracheal intubation', 'description': 'Observation during airway management'}, {'measure': 'Lowest oxygen saturation during airway management', 'timeFrame': '30 minutes after endotracheal intubation', 'description': 'Observation during airway management'}, {'measure': 'Initial end-tidal carbon dioxide level after successful intubation', 'timeFrame': '30 minutes after endotracheal intubation', 'description': 'Observation during airway management'}, {'measure': 'Observed complications during or after induction of general anesthesia', 'timeFrame': '30 minutes after endotracheal intubation', 'description': 'Questionnaire'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Until hospital discharge up to 3 months after surgery', 'description': 'Follow-up'}, {'measure': 'All cause in-hospital mortality', 'timeFrame': 'Until hospital discharge up to 3 months after surgery', 'description': 'Follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Airway Management', 'Intubation', 'Bronchoscopes', 'Risk Assessment', 'Surgery'], 'conditions': ['Oral Surgery', 'Maxillofacial Surgery']}, 'referencesModule': {'references': [{'pmid': '38098848', 'type': 'DERIVED', 'citation': 'Wunsch VA, Kohl V, Breitfeld P, Bauer M, Sasu PB, Siebert HK, Dankert A, Stark M, Zollner C, Petzoldt M. Hyperangulated blades or direct epiglottis lifting to optimize glottis visualization in difficult Macintosh videolaryngoscopy: a non-inferiority analysis of a prospective observational study. Front Med (Lausanne). 2023 Nov 30;10:1292056. doi: 10.3389/fmed.2023.1292056. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Primary aim of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing oral and maxillofacial (OMF) or ear, nose and throat (ENT) surgery. Furthermore, this study intends to assess the diagnostic value of preoperative flexible nasal videoendoscopy to predict difficult videolaryngoscopic intubation in these patients.', 'detailedDescription': 'Difficult endotracheal intubation is a major reason for anesthesia related adverse events. Videolaryngoscopy has become an important part of the anesthesiological standard of care for difficult airway management in the past decades. Still, medical preconditions, as well as procedural and technical factors related with difficult videolaryngoscopy have not been systematically investigated, and a standardized comprehensive classification system for the severity of videolaryngoscopic intubation has yet to be specified. The primary objective of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing ENT or OMF surgery.\n\nPatients with conditions of the ENT and OMF spectrum have a predisposition for difficult airway management and are at high risk for adverse events during endotracheal intubation. However, current recommendations for preoperative screening for difficult intubation rarely consider space consuming lesions of the laryngopharyngeal region. Comprehensive data identifying the predictive value of preoperative flexible nasal videoendoscopy as a diagnostic measure to anticipate difficult airway management still lack. Thus, secondary aim of this study is to evaluate the diagnostic value and clinical significance of preoperative flexible nasal videoendoscopy to predict difficult videolaryngoscopic intubation in these patients.\n\nStudy design:\n\nThe investigators conduct a prospective observational study, which includes 400 patients with predicted difficult airway and confirmed indication for flexible nasal videoendoscopy and videolaryngoscopic intubation undergoing ENT or OMF surgery.\n\nProcedural and surgical data as well as medical preconditions will be assessed systematically. The handling anesthetist and two independent observers will be surveyed (structured questionnaire) in order to assess procedural and technical factors related with videolaryngoscopic intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ENT or OMF surgical patients presenting at the Anesthesiology Preassessment Clinic of the University Medical Center Hamburg-Eppendorf for preoperative risk assessment will be checked for eligibility. Repeated inclusions of participators are allowed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 18 Years and older\n* Patients scheduling for ENT or OMF surgery under general anesthesia with requirement of endotracheal Intubation\n* Risk of difficult airway management with confirmed indication for videolaryngoscopic intubation\n\nExclusion criteria:\n\n* No consent given\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03950934', 'acronym': 'VIDiAC', 'briefTitle': 'Videolaryngoscopic Intubation and Difficult Airway Classification', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Classification and Prediction of Difficult Videolaryngoscopic Intubation in Patients Undergoing Oral and Maxillofacial or Ear, Nose and Throat Surgery', 'orgStudyIdInfo': {'id': 'PV5856'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention, observational study, perioperative survey', 'type': 'OTHER', 'description': 'no intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Martin Petzoldt, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, University Medical Center Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}