Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT03567902
Status:
UNKNOWN
Last Update Posted:
2018-06-26
First Post:
2018-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
C-MAC Videolaryngoscope Intubation and Cervical Spine Motion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-22', 'studyFirstSubmitDate': '2018-05-31', 'studyFirstSubmitQcDate': '2018-06-22', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum cervical spine motion (degree)', 'timeFrame': 'During tracheal intubation time, an expected average of 90 seconds', 'description': 'Maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments'}], 'secondaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': 'Within 90 seconds from insertion of device', 'description': "Check the intubation time (seconds) defines 'from insertion of device to oral cavity of patients to confirm successful intubation'"}, {'measure': 'Number of intubation trial', 'timeFrame': 'During tracheal intubation time, an expected average of 1 minutes', 'description': 'Check the number of intubation trial'}, {'measure': 'Postoperative complications', 'timeFrame': 'During PACU stay time expected up to 1 hr', 'description': 'Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score'}, {'measure': 'Postoperative complications', 'timeFrame': '24 hr after operation', 'description': 'Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score'}, {'measure': 'Postoperative complications', 'timeFrame': 'After extubation, immediate postoperative period', 'description': 'Blood tinged endotracheal tube ( yes or no)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['C-MAC'], 'conditions': ['Intubation;Difficult', 'Cervical Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '16116013', 'type': 'BACKGROUND', 'citation': 'Turkstra TP, Craen RA, Pelz DM, Gelb AW. Cervical spine motion: a fluoroscopic comparison during intubation with lighted stylet, GlideScope, and Macintosh laryngoscope. Anesth Analg. 2005 Sep;101(3):910-915. doi: 10.1213/01.ane.0000166975.38649.27.'}, {'pmid': '18292443', 'type': 'BACKGROUND', 'citation': 'Robitaille A, Williams SR, Tremblay MH, Guilbert F, Theriault M, Drolet P. Cervical spine motion during tracheal intubation with manual in-line stabilization: direct laryngoscopy versus GlideScope videolaryngoscopy. Anesth Analg. 2008 Mar;106(3):935-41, table of contents. doi: 10.1213/ane.0b013e318161769e.'}, {'pmid': '28244946', 'type': 'BACKGROUND', 'citation': 'Kim TK, Son JD, Seo H, Lee YS, Bae J, Park HP. A Randomized Crossover Study Comparing Cervical Spine Motion During Intubation Between Two Lightwand Intubation Techniques in Patients With Simulated Cervical Immobilization: Laryngoscope-Assisted Versus Conventional Lightwand Intubation. Anesth Analg. 2017 Aug;125(2):485-490. doi: 10.1213/ANE.0000000000001813.'}, {'pmid': '32799791', 'type': 'DERIVED', 'citation': 'Paik H, Park HP. Randomized crossover trial comparing cervical spine motion during tracheal intubation with a Macintosh laryngoscope versus a C-MAC D-blade videolaryngoscope in a simulated immobilized cervical spine. BMC Anesthesiol. 2020 Aug 15;20(1):201. doi: 10.1186/s12871-020-01118-3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the effect of the C-MAC videolaryngoscope intubation technique vs. the conventional direct laryngoscope intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization.', 'detailedDescription': "When the intubation is required in patients with an injured cervical spine, securing the airway while minimizing C-spine motion to prevent neurological damage can be very difficult. The awake intubation using a flexible bronchoscope is preferred as it minimizes C-spine motion. However, in the emergent clinical practice, direct laryngoscopy with manual in-line stabilization is most commonly used, because it is quicker and does not require patient collaboration. Numerous alternatives to direct laryngoscopy and fiberoptic bronchoscopy have been studied. But, none of these methods combines the convenience of direct laryngoscopy and the C-spine immobility afforded by intubation using a fiberoptic bronchoscope patient with an injured C-spine.\n\nThe videolaryngoscopy has recently developed extensively and become more widely available. It has the potential of combining the advantages of both direct laryngoscopy and intubation using a fiberoptic bronchoscope. Indeed, it provides an indirect view of the glottis, which could diminish C-spine movement, but its handling shares many similarities with direct laryngoscopy, which could make it more convenient than the flexible bronchoscope.\n\nIn the previous study examining C-spine movement during direct laryngoscopy and GlideScope® videolaryngoscopy, found no difference in movement at the rostral level but showed significantly less movement of the inferior C-spine with GlideScope® videolaryngoscopy. We postulate that C-MAC videolaryngoscope will induce less movement than direct laryngoscopy. The effect of C-MAC videolaryngoscope intubation technique on cervical spine motion is not investigated yet.\n\nIn this study, C-spine stabilization will be provided by Philadelphia neck collar. We will investigate a prospective cinefluoroscopic study comparing C-spine motion during direct laryngoscopy and C-MAC videolaryngoscope in patients with an intact C-spine stabilized by Philadelphia collar.\n\nThe duration and maximum change for C-MAC videolaryngoscope intubation technique was compared to those with direct laryngoscopy at each motion segment using a Student's paired t-test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with American Society of Anesthesiologists physical status of 1-2 and age of 20-80 years undergoing elective endovascular coiling to secure cerebral aneurysm under general anesthesia in neuroangiographic rooms.\n\nExclusion Criteria:\n\n* Patients with C-spine injury, C-spine disease\n* Patients with past medical history of C-spine surgery or intervention\n* Patients with the upper airway abnormalities, such as inflammation, abscesses, tumours, polyps, or trauma.\n* Patients with past medical history of gastro-oesophageal reflux disease and previous airway surgery, a high risk of aspiration, coagulation disorders, or Hunt Hess grade of 3-5.\n* Body mass index \\> 30'}, 'identificationModule': {'nctId': 'NCT03567902', 'briefTitle': 'C-MAC Videolaryngoscope Intubation and Cervical Spine Motion', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Randomized Trial on Comparison of Cervical Spine Motion During Tracheal Intubation Using Direct Laryngoscope Versus C-MAC Videolaryngoscope in Simulated Immobilized Cervical Spine', 'orgStudyIdInfo': {'id': '1804-123-940'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'C-MAC videolaryngoscope intubation -\\> Direct laryngoscope intubation', 'interventionNames': ['Device: C-MAC videolaryngoscope intubation', 'Device: Direct laryngoscope intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Direct laryngoscope intubation -\\> C-MAC videolaryngoscope intubation', 'interventionNames': ['Device: C-MAC videolaryngoscope intubation', 'Device: Direct laryngoscope intubation']}], 'interventions': [{'name': 'C-MAC videolaryngoscope intubation', 'type': 'DEVICE', 'description': 'C-MAC videolaryngoscope intubation', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Direct laryngoscope intubation', 'type': 'DEVICE', 'description': 'Direct laryngoscope intubation', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hee Pyung Park, MD PhD', 'role': 'CONTACT', 'email': 'hppark@snu.ac.kr', 'phone': '82-2-2072-2466'}, {'name': 'Hyesun Paik, MD', 'role': 'CONTACT', 'email': 'molf0917@gmail.com', 'phone': '82-2- 2072-2469'}], 'overallOfficials': [{'name': '82-2- 2072-2469 Park, Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University of Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Hee-Pyoung Park', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}