Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-02-17 @ 11:11 PM
Study NCT ID:
NCT01692535
Status:
COMPLETED
Last Update Posted:
2015-06-11
First Post:
2012-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Video Laryngoscopes in Difficult Airway
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 720}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-10', 'studyFirstSubmitDate': '2012-09-17', 'studyFirstSubmitQcDate': '2012-09-24', 'lastUpdatePostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First attempt intubation success rate', 'timeFrame': 'within 180 seconds'}], 'secondaryOutcomes': [{'measure': 'side effects', 'timeFrame': '1h and 1 day after surgery', 'description': 'sore throat, bleeding, dental injuries'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intubation; Difficult']}, 'referencesModule': {'references': [{'pmid': '27106971', 'type': 'DERIVED', 'citation': 'Kleine-Brueggeney M, Greif R, Schoettker P, Savoldelli GL, Nabecker S, Theiler LG. Evaluation of six videolaryngoscopes in 720 patients with a simulated difficult airway: a multicentre randomized controlled trial. Br J Anaesth. 2016 May;116(5):670-9. doi: 10.1093/bja/aew058.'}, {'pmid': '23556410', 'type': 'DERIVED', 'citation': 'Theiler L, Hermann K, Schoettker P, Savoldelli G, Urwyler N, Kleine-Brueggeney M, Arheart KL, Greif R. SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland. Trials. 2013 Apr 4;14:94. doi: 10.1186/1745-6215-14-94.'}]}, 'descriptionModule': {'briefSummary': 'In this multicenter study the investigators are going to evaluate the use of six different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these six videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As gold standard, a standard Macintosh blade is being used.\n\nThe study consists of 6 arms. Each arm includes 120 patients, sums up to a total of 720 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective surgery with general anesthesia requiring intubation\n* \\>18years old\n* ASA I-III\n\nExclusion Criteria:\n\n* known or presumed difficult airway\n* risk of pulmonary aspiration\n* refusing to participate'}, 'identificationModule': {'nctId': 'NCT01692535', 'acronym': 'SWIVIT I', 'briefTitle': 'Evaluation of Video Laryngoscopes in Difficult Airway', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Multicenter Study Evaluating Video Laryngoscopes: The Swiss Video-Intubation Trial (SWIVIT I)', 'orgStudyIdInfo': {'id': '106/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GlideScope', 'description': 'intubation', 'interventionNames': ['Procedure: Intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Airtraq', 'description': 'intubation', 'interventionNames': ['Procedure: Intubation']}, {'type': 'EXPERIMENTAL', 'label': 'McGrath MAC', 'description': 'intubation', 'interventionNames': ['Procedure: Intubation']}, {'type': 'EXPERIMENTAL', 'label': 'King Vision', 'description': 'intubation', 'interventionNames': ['Procedure: Intubation']}, {'type': 'EXPERIMENTAL', 'label': 'A.P. Advance', 'description': 'intubation', 'interventionNames': ['Procedure: Intubation']}, {'type': 'EXPERIMENTAL', 'label': 'C-MAC', 'description': 'intubation', 'interventionNames': ['Procedure: Intubation']}], 'interventions': [{'name': 'Intubation', 'type': 'PROCEDURE', 'description': 'Intubation with one of the six videolaryngoscopes', 'armGroupLabels': ['A.P. Advance', 'Airtraq', 'C-MAC', 'GlideScope', 'King Vision', 'McGrath MAC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3011', 'city': 'Bern', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'Bern University Hospital and University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'Hopitaux Universitaires de Geneve HUG', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Robert Greif, MD MME FERC', 'role': 'STUDY_CHAIR', 'affiliation': 'University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, {'name': 'University Hospital, Geneva', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lorenz Theiler', 'investigatorAffiliation': 'Insel Gruppe AG, University Hospital Bern'}}}}