Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-29 @ 5:43 PM
Study NCT ID:
NCT06993961
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2025-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Measurement of Optic Nerve Sheath Diameter as Non-Invasive Detector of Raised Intracranial Pressure in Adult Traumatic and Non-Traumatic Neurocritical Patients in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracranial Pressure', 'timeFrame': '24 hours post-procedure', 'description': 'Non-invasive bedside intracranial pressure (ICP) assessment via ultrasound (US) measurement of optic nerve sheath diameter (ONSD).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasound', 'Optic Nerve Sheath Diameter', 'Non-Invasive', 'Intracranial Pressure', 'Neurocritical', 'Intensive Care Unit']}, 'descriptionModule': {'briefSummary': 'This study aimed to assess the role of ultrasound as a non-invasive method (bedside) to measure the rise of intracranial pressure by measuring the optic nerve sheath diameter in traumatic and nontraumatic neurocritical patients.', 'detailedDescription': 'Measurement of intracranial pressure (ICP) is crucial in the management of many neurological conditions. However, due to the invasiveness, high cost, and required expertise of available ICP monitoring techniques, many patients who could benefit from it do not receive it. As a result, a substantial effort has been made to explore and develop novel non-invasive ICP monitoring techniques to improve the overall clinical care of patients suffering from ICP disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This observational prospective trial involved 50 cases aged \\>18 years old, both sexes, presenting with suspected high intracranial pressure (ICP). The study was conducted from August 2022 to July 2023 after approval from the Ethical Committee of Ain Shams University Hospitals, Cairo, Egypt.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years old.\n* Both sexes.\n* Patients with suspected high intracranial pressure.\n\nExclusion Criteria:\n\n* Cases suffering from eye disease or optic nerve problems (Glaucoma, optic Nerve Tumor, Neuritis, Orbital Fracture).\n* Patients suffering from mental illness render them incapable of communication \\& cooperation (For Example: Dementia and irritability).\n* Any previous intensive care surgeries \\& hyperthyroidism (due to exophthalmos)'}, 'identificationModule': {'nctId': 'NCT06993961', 'briefTitle': 'Ultrasound Measurement of Optic Nerve Sheath Diameter as Non-Invasive Detector of Raised Intracranial Pressure in Adult Traumatic and Non-Traumatic Neurocritical Patients in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Ultrasound Measurement of Optic Nerve Sheath Diameter as Non-Invasive Detector of Raised Intracranial Pressure in Adult Traumatic and Non-Traumatic Neurocritical Patients in ICU', 'orgStudyIdInfo': {'id': 'MD 265/2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patient with suspected high intracranial pressure (ICP) as determined by initial computed tomography (CT) brain.', 'interventionNames': ['Device: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'Ultrasound (US) measurement of optic nerve sheath diameter (ONSD) was performed.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.', 'investigatorFullName': 'Kareem Elsaeed abdelwahab', 'investigatorAffiliation': 'Ain Shams University'}}}}