Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT01122433
Status:
COMPLETED
Last Update Posted:
2010-09-28
First Post:
2010-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Airway Management Study to Evaluate the C-MAC Video Laryngoscope as an Alternative to the Direct Laryngoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-27', 'studyFirstSubmitDate': '2010-05-05', 'studyFirstSubmitQcDate': '2010-05-12', 'lastUpdatePostDateStruct': {'date': '2010-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of endotracheal intubation using the C-MAC video laryngoscope', 'description': 'The investigators evaluate the C-MAC as an alternative after failed direct laryngoscopy. Primary outcome measure is the success rate using the C-MAC video laryngoscope in unexpected difficult airways.'}], 'secondaryOutcomes': [{'measure': '- improved glottic view', 'description': 'According to the Cormacl-Lehane classification the improved glottis view using the C-MAC is documented.'}, {'measure': '- complications', 'description': 'Possible complications are supra glottic trauma, tooth damage, soft tissure bleeding,...'}, {'measure': '- numbers of intubation attempts', 'description': 'Necessary intubation attempts using the C-MAC video laryngoscope to secutre the airway.'}, {'measure': '- size of blade (C-MAC)', 'description': 'Different blades are available for the C-MAC. We evaluate with which blade securing the airway was possible.'}]}, 'conditionsModule': {'keywords': ['difficult airway', 'indirect laryngoscopy', 'C-MAC video laryngoscope'], 'conditions': ['Unexpected Difficult Airway']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the C-MAC video laryngoscope in difficult airway situations.', 'detailedDescription': 'Unanticipated difficulties during tracheal intubation and failure to intubate are among the leading causes of anaesthesia related morbidity and mortality. Using the technique of video laryngoscopy, the alignment of the oral and pharyngeal axis to facilitate endotracheal intubation is obsolete. In this study we evaluate the C-MAC video laryngoscope (STORZ, Tuttlingen, Germany) for endotracheal intubation in difficult intubation situations (Cormack \\& Lehane (CL) grade 3 and 4) validated by Macintosh laryngoscope. We hypothesize that endotracheal intubation is possible using the C-MAC in patients after failed direct laryngoscopy. We also examine whether visualisation of the glottis is improved with this device compared to direct laryngoscopy and possible complications such as soft tissue injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unexpected difficult airway\n\nExclusion Criteria:\n\n* History of difficult or impossible mask ventilation\n* Age \\< 18 years\n* ASA grade \\> 3\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT01122433', 'briefTitle': 'Airway Management Study to Evaluate the C-MAC Video Laryngoscope as an Alternative to the Direct Laryngoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Evaluation of the C-MAC Video Laryngoscope After Failed Direct Laryngoscopy', 'orgStudyIdInfo': {'id': 'PN-201005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C-MAC', 'description': 'After a maximum of three failed intubation attempts using direct laryngoscope the C-MAC video laryngoscope is used as an emergency airway device.', 'interventionNames': ['Device: Endotracheal intubation using the C-MAC video laryngoscope']}], 'interventions': [{'name': 'Endotracheal intubation using the C-MAC video laryngoscope', 'type': 'DEVICE', 'description': 'Using the C-MAC video laryngoscope for endotracheal intubation after failed direct laryngoscopy', 'armGroupLabels': ['C-MAC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Univeritätsmedizin of the JG University, Department of Anaesthesiology', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Tim Piepho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology, Universitätsmedizin Mainz'}, {'name': 'Rüdiger R Noppens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology, Universitätsmedizin Mainz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Department of Anaesthesiology, Prof. C. Werner', 'oldOrganization': 'Universitätsmedizin of the JG University'}}}}