Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04507620
Status:
UNKNOWN
Last Update Posted:
2020-08-11
First Post:
2020-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Cervical Immobilization on Optic Nerve Sheath Diameter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-09', 'studyFirstSubmitDate': '2020-08-06', 'studyFirstSubmitQcDate': '2020-08-09', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of cervical neck collar and head blocks strapped on the backboard on Optic Nerve Sheath Diameter', 'timeFrame': '6 month', 'description': 'effect of cervical neck collar and head blocks strapped on the backboard on optic nerve sheath diameter, measured by point of care ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical immobilization'], 'conditions': ['Optic Nerve Sheath Diameter', 'Point of Care Ultrasound']}, 'descriptionModule': {'briefSummary': 'Effect of Cervical Immobilization on Optic Nerve Sheath Diameter', 'detailedDescription': 'Two cervical immobilization devices will be used in this study named cervical neck collar and head blocks strapped on the backboard and optic nerve diameter will be measured using point of care ultrasound and compare the effect of each type of cervical immobilisation on optic nerve sheath diameter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective study will be done on 100 medical students, emergency medicine and traumatology residents and assistant lecturers ,Tanta university faculty of medicine, healthy volunteers during a period of 6 months.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult healthy volunteers aged more than 18 years\n\nExclusion Criteria:\n\n* Hx of stroke\n\n * Inability to consent,\n * Inability to lay flat on a bed or table for 15 min in duration,\n * History of glaucoma, globe injury, lens implant,\n * Recent refractive surgery (within the past 60 days).\n * Uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT04507620', 'briefTitle': 'Effect of Cervical Immobilization on Optic Nerve Sheath Diameter', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effect of Cervical Neck Collar and Head Blocks Strapped on the Backboard on Optic Nerve Sheath Diameter', 'orgStudyIdInfo': {'id': '33935/7/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cervical neck collar', 'interventionNames': ['Device: cervical neck collar']}, {'label': 'head blocks strapped on the backboard', 'interventionNames': ['Device: cervical neck collar']}], 'interventions': [{'name': 'cervical neck collar', 'type': 'DEVICE', 'otherNames': ['head blocks strapped on the backboard'], 'description': 'devices used for cervical immobilization', 'armGroupLabels': ['cervical neck collar', 'head blocks strapped on the backboard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed G Elbahnasawy, MD', 'role': 'CONTACT', 'email': 'drmogabehn@gmail.com', 'phone': '01091291077', 'phoneExt': '+20'}], 'facility': 'Mohamed Elbahnasawy', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'consultant of emergency medicine and traumatology', 'investigatorFullName': 'Mohamed Elbahnasawy, MD', 'investigatorAffiliation': 'Tanta University'}}}}