Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-07 @ 1:56 PM
Study NCT ID:
NCT03742427
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2018-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Cervical Collar on the Optic Nerve Sheath Diameter in Minor Head Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006259', 'term': 'Craniocerebral Trauma'}], 'ancestors': [{'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karacabeysinan@gmail.com', 'phone': '+902166254545', 'title': 'Sinan KARACABEY', 'organization': 'Marmara University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 hour from appealing to emergency department', 'description': 'No serious adverse events (death) or other adverse events (pain, hypotension, loss of vision ) were observed till the time frame due to study.', 'eventGroups': [{'id': 'EG000', 'title': 'Effect of C-collar in Optic Nerve Sheath Diameter', 'description': 'Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography\n\nultrasonography: optic nerve sheath diameter measurement will be done by ultrasonography on both eyes', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Effect of C-collar in Optic Nerve Sheath Diameter', 'description': 'Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography\n\nultrasonography: optic nerve sheath diameter measurement will be done by ultrasonography on both eyes'}], 'classes': [{'title': '0th Minute', 'categories': [{'measurements': [{'value': '4.71', 'spread': '0.22', 'groupId': 'OG000'}]}]}, {'title': '5th minute', 'categories': [{'measurements': [{'value': '5.19', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': '20th minute', 'categories': [{'measurements': [{'value': '5.26', 'spread': '0.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 minutes', 'description': 'We hypothesised that optic nerve sheath diameter raises after c-collar application in minor head trauma patients', 'unitOfMeasure': 'Milimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Effect of C-collar in Optic Nerve Sheath Diameter', 'description': 'Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography\n\nultrasonography: optic nerve sheath diameter measurement will be done by ultrasonography on both eyes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Effect of C-collar in Optic Nerve Sheath Diameter', 'description': 'Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography\n\nultrasonography: optic nerve sheath diameter measurement will be done by ultrasonography on both eyes'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39.44', 'spread': '6.56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Optic Nerve Sheath Diameter', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.71', 'spread': '0.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'These measurements are the baseline measurements of the patients at time point "0" when they appeal to the emergency department before c-collar application.', 'unitOfMeasure': 'milimeters', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-13', 'size': 135768, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-24T04:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-16', 'studyFirstSubmitDate': '2018-09-25', 'resultsFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-16', 'studyFirstPostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients', 'timeFrame': '20 minutes', 'description': 'We hypothesised that optic nerve sheath diameter raises after c-collar application in minor head trauma patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasonography', 'optic nerve sheath', 'head trauma'], 'conditions': ['Head Trauma']}, 'referencesModule': {'references': [{'pmid': '28865838', 'type': 'BACKGROUND', 'citation': 'Woster CM, Zwank MD, Pasquarella JR, Wewerka SS, Anderson JP, Greupner JT, Motalib S. Placement of a cervical collar increases the optic nerve sheath diameter in healthy adults. Am J Emerg Med. 2018 Mar;36(3):430-434. doi: 10.1016/j.ajem.2017.08.051. Epub 2017 Aug 26.'}, {'pmid': '28727580', 'type': 'BACKGROUND', 'citation': 'Maissan IM, Ketelaars R, Vlottes B, Hoeks SE, den Hartog D, Stolker RJ. Increase in intracranial pressure by application of a rigid cervical collar: a pilot study in healthy volunteers. Eur J Emerg Med. 2018 Dec;25(6):e24-e28. doi: 10.1097/MEJ.0000000000000490.'}]}, 'descriptionModule': {'briefSummary': "This is randomized, controlled and blinded study was performed in minor head trauma patients. Two sonographers measured optic nerve sheath diameters (ONSD) of each subjects' eyes separately for different time points. Then a mean ONSD was calculated for before c-collar placement (T0), 5 and 20 minutes in supine position.", 'detailedDescription': "Head trauma is an important cause of morbidity and mortality. Increased intracranial pressure (ICP) can lead to decreased cerebral perfusion and tissue damage. It is important to be able to detect increased ICP on time, so that treatment can be initiated to prevent further brain damage. The measurement of optic nerve sheath diameter (ONSD) has been proposed as a non-invasive and rapid way to assess elevated ICP (1-2). Traditional ICP monitoring methods such as external ventricular devices are invasive and time-consuming and can only be performed by trained personnel at trauma centers.\n\nThe optic nerve is surrounded by a protective sheath and is found on the back of the globe. Easily evaluated with ultrasonics. This is typically done with a linear probe measuring the diameter of the optic nerve sheath 3 mm back from where the contrast is highest. The normal upper limit for adults is 5 mm, the values above are considered abnormal. Many studies have shown that an increased ONSD measured by bedside ultrasound correlates with increased IDC and in one study there is a correlation between ONSD\\> 5 mm and ICP\\> 20 cm H2O.\n\nCervical spine (c-arms) and cervical vertebrae are often temporarily immobilized in patients with head trauma. It has been shown that placement of c-arms increases IBP. The decrease in venous outflow caused by c-arms in the forehead is an important mechanism for this increase in ICP. The increase in ICP occurs simultaneously with the application of c-arms in cadaver. It is thought that increased ONSD in trauma patients may be related to c-arms.\n\nIf a c-collar application is found to increase ONSD, this trauma may make it difficult to use ONSD as an non-invasive estimate of ICP in patients.\n\nTo the best of our knowledge, there is a study in healthy individuals investigating the possible effect of c-collar administration on ONSD. However, there is no comparative study of patients with head trauma. The investigators tried to measure ONSD before and after placement of cervical limbs in cases with minor head trauma. The aim of our study is to identify changes in the optic nerve sheath measurement after placement of the c-arms, and to determine whether these changes are due to the time immobilized by the c-arms.\n\nThis is randomized, controlled and blinded study was performed in minor head trauma patients. Two sonographers measured optic nerve sheath diameters (ONSD) of each subjects' eyes separately for different time points. Then a mean ONSD was calculated for before c-collar placement (T0), 5 and 20 minutes in supine position."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with minor head trauma\n* Patients over 18 years and under 65 years\n* Those who signed the Informed Consent Form\n\nExclusion Criteria:\n\n* Patients who can not be followed for any reason (treatment, refusal, unauthorized leave, referral to the center, etc.)\n* Patients who withdraw their consent'}, 'identificationModule': {'nctId': 'NCT03742427', 'briefTitle': 'Effect of Cervical Collar on the Optic Nerve Sheath Diameter in Minor Head Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Effect of Cervical Collar on the Optic Nerve Sheath in Minor Head Trauma Patients', 'orgStudyIdInfo': {'id': '09.2018.298'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'effect of c-collar in optic nerve sheath diameter', 'description': 'Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography', 'interventionNames': ['Diagnostic Test: ultrasonography']}], 'interventions': [{'name': 'ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'optic nerve sheath diameter measurement will be done by ultrasonography on both eyes', 'armGroupLabels': ['effect of c-collar in optic nerve sheath diameter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34687', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sinan Karacabey', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Sinan Karacabey', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Marmara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}