Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 1:23 AM
Study NCT ID:
NCT03115606
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2017-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of C-Mac D Blade and Fastrach Laryngeal Mask Airway on Cervical Spine Motion Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-09', 'studyFirstSubmitDate': '2017-03-26', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Angle A (degree), Angle B (degree), Angle C(degree)', 'timeFrame': '30 second', 'description': 'Angle of the line between occipital protuberance and central point of spinous process of C1 vertebrae. Angle B and Angle C (degree)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['videolaryngoscope', 'Fastrach LMA', 'cervical motion'], 'conditions': ['Intubation Complication', 'Cervical Discopathy']}, 'referencesModule': {'references': [{'pmid': '30627738', 'type': 'DERIVED', 'citation': 'Ozkan D, Altinsoy S, Sayin M, Dolgun H, Ergil J, Donmez A. Comparison of cervical spine motion during intubation with a C-MAC D-Blade(R) and an LMA Fastrach(R). Anaesthesist. 2019 Feb;68(2):90-96. doi: 10.1007/s00101-018-0533-3. Epub 2019 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'In patients with cervical spine disorders or hernia, in-line stabilization and immobilization during tracheal intubation is used to avoid neck injury. With direct laryngoscopy cranio-cervical motion can result injury. The aim of the study is to compare two different device (C-Mac D blade versus fastrach LMA ) regarding cervical motions during intubation.', 'detailedDescription': 'In simulated or clinical settings of restricted neck mobility, videolaryngoscopes and fastrach LMA have performed well but neck motion can be occured. Endotracheal intubation will be performed under fluoroscopy. In this study the neck motion angles will be investigated during intubation . The angles will be assessed on fluoroscopy images. A Angle: Angle of the line between occipital protuberance and anterior process of the foramen magnum with the line between central point of spinous process C1 vertebrae and the anterior process of foramen magnum. The reference line for the occiput is defined as a line between the base of the sella and the opisthion (lineA), and the C1 reference line as a line between the lower cortical margin of the spinous process (line B). The C2 reference line is defined as a line between the anterior , inferior margin of the C2 body and the lower cortical margin of the C2 spinous process (lineC). The C5 reference line is a tangent along the superior endplate of the C5 vertebral body (line D). The groups will be compared statistically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of cervical disc herniation ( scheduled cervical discectomy)\n2. American Society of Anesthesiology (ASA) physical status I-III patients\n\nExclusion Criteria:\n\n1. ASA IV patients\n2. Age under 18 years, over 70 years\n3. Hepatic disease\n4. Renal disease\n5. Cardiac disease\n6. Pregnancy\n7. Anticipated difficult airway'}, 'identificationModule': {'nctId': 'NCT03115606', 'briefTitle': 'Comparison of C-Mac D Blade and Fastrach Laryngeal Mask Airway on Cervical Spine Motion Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Comparison of C-Mac D Blade and Fastrach Laryngeal Mask Airway on Cervical Spine Motion Conditions in Cervical Discectomy', 'orgStudyIdInfo': {'id': 'Diskapi3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Videolaryngoscope', 'description': 'Patients intubated with C-Mac D Blade Videolaryngoscope', 'interventionNames': ['Device: C-Mac D Blade']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fastrach LMA', 'description': 'Patients intubated with Fastrach LMA', 'interventionNames': ['Device: Fastrach LMA']}], 'interventions': [{'name': 'C-Mac D Blade', 'type': 'DEVICE', 'description': 'Videolaryngoscope', 'armGroupLabels': ['Videolaryngoscope']}, {'name': 'Fastrach LMA', 'type': 'DEVICE', 'description': 'Laryngeal mask airway', 'armGroupLabels': ['Fastrach LMA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06810', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey Ankara, Turkey', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'derya özkan, assoc prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Anesthesiology and Reanimation Clinic Ankara, Turkey Ankara, Turkey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'derya özkan', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}