Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-29 @ 6:19 AM
Study NCT ID:
NCT01635660
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
2012-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007440', 'term': 'Intubation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-01', 'studyFirstSubmitDate': '2012-07-04', 'studyFirstSubmitQcDate': '2012-07-06', 'lastUpdatePostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation success', 'timeFrame': 'Immediately after intubation'}], 'secondaryOutcomes': [{'measure': 'Intubation on first attempt', 'timeFrame': 'Immediately after intubation'}, {'measure': 'Intubation time', 'timeFrame': 'Immediately after intubation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Out-of-hospital', 'airway management', 'intubation', 'video laryngoscope'], 'conditions': ['Intubation Intratracheal', 'Airway Management', 'Emergency Treatment']}, 'referencesModule': {'references': [{'pmid': '29239965', 'type': 'DERIVED', 'citation': 'Cavus E, Janssen S, Reifferscheid F, Caliebe A, Callies A, von der Heyden M, Knacke PG, Doerges V. Videolaryngoscopy for Physician-Based, Prehospital Emergency Intubation: A Prospective, Randomized, Multicenter Comparison of Different Blade Types Using A.P. Advance, C-MAC System, and KingVision. Anesth Analg. 2018 May;126(5):1565-1574. doi: 10.1213/ANE.0000000000002735.'}]}, 'descriptionModule': {'briefSummary': 'This research project examines the effectiveness of different video laryngoscopes in a out-of-hospital emergency intubation. Since in preclinical airway management severe incidents with esophageal failures of intubation may partly happen or rather endotracheal Intubation may completely fail, it is of great importance to evaluate alternative ways of endotracheal intubation in out-of-hospital emergency medicine. Video laryngoscopy has been proven in everyday clinical practice and may clinically be superior in most situations when compared to endotracheal Intubation using a conventional laryngoscope. No data exist, if different video laryngoscope types perform differently in the out-of-hospital setting. The investigators hypothesize that there would be no difference with regard to intubation time, intubation success, and intubation morbidity between different models of video laryngoscopes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All adult emergency patients, age 18 years and older for whom a preclinical emergency intubation is necessary\n\nExclusion Criteria:\n\n* Age under 18 years\n* Laryngoscopy according to the algorithm of airway management not being indicated'}, 'identificationModule': {'nctId': 'NCT01635660', 'briefTitle': 'Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Prospective, Randomized, Multicentre Evaluation of Different Video-assisted, for Emergency Use Designed Intubation Aids for Out-of-hospital Endotracheal Intubation. Comparison of C-MAC System PM (Karl Storz), AP Advance (Venner Medical), and King Vision (King Systems) at Four German HEMS.', 'orgStudyIdInfo': {'id': 'ANKIEL-VLS-2012-CAV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'C-MAC System', 'interventionNames': ['Device: Intubation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AP Advance', 'interventionNames': ['Device: Intubation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'King Vision', 'interventionNames': ['Device: Intubation']}], 'interventions': [{'name': 'Intubation', 'type': 'DEVICE', 'description': 'Tracheal Intubation with the assigned video laryngoscope', 'armGroupLabels': ['AP Advance', 'C-MAC System', 'King Vision']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bremen', 'country': 'Germany', 'facility': 'Klinikum LDW / NEF Bremen Süd', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Greifswald', 'country': 'Germany', 'facility': 'Uniklinikum Greifswald / DRF Luftrettung', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '24768', 'city': 'Rendsburg', 'country': 'Germany', 'facility': 'Uniklinikum Kiel / DRF Luftrettung', 'geoPoint': {'lat': 54.30182, 'lon': 9.67175}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karl Storz Endoscopy, Germany', 'class': 'UNKNOWN'}, {'name': 'King Systems Corporation', 'class': 'INDUSTRY'}, {'name': 'LMA, Germany', 'class': 'UNKNOWN'}, {'name': 'Venner Medical, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Erol Cavus', 'investigatorFullName': 'Erol Cavus', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}