Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT06367868
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019586', 'term': 'Intracranial Hypertension'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-13', 'studyFirstSubmitDate': '2024-04-05', 'studyFirstSubmitQcDate': '2024-04-13', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracranial Pressure-1 (ICP-1)', 'timeFrame': 'baseline time', 'description': 'Measurement of intracranial pressure before cerebrospinal fluid (CSF) drainage'}, {'measure': 'Optic Nerve Sheath Diameter-1 (ONSD-1)', 'timeFrame': 'baseline time', 'description': 'Measurement of optic nerve sheath diameter before cerebrospinal fluid drainage'}], 'secondaryOutcomes': [{'measure': 'Intracranial Pressure-2 (ICP-2)', 'timeFrame': '2 minutes after CSF drainage', 'description': 'Measurement of intracranial pressure 2 minutes after cerebrospinal fluid (CSF) drainage'}, {'measure': 'Optic Nerve Sheath Diameter-2 (ONSD-2)', 'timeFrame': '2 minutes after CSF drainage', 'description': 'Measurement of optic nerve sheath diameter 2 minutes after cerebrospinal fluid drainage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ONSD', 'ultrasonography', 'noninvasive', 'increased intracranial pressure'], 'conditions': ['ICP (Intracranial Pressure) Increase', 'Optic Nerve Sheath Diameter', 'Intracranial Hypertension']}, 'referencesModule': {'references': [{'pmid': '30019201', 'type': 'BACKGROUND', 'citation': 'Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17.'}, {'pmid': '36983213', 'type': 'BACKGROUND', 'citation': 'Muller SJ, Henkes E, Gounis MJ, Felber S, Ganslandt O, Henkes H. Non-Invasive Intracranial Pressure Monitoring. J Clin Med. 2023 Mar 13;12(6):2209. doi: 10.3390/jcm12062209.'}, {'pmid': '32852360', 'type': 'BACKGROUND', 'citation': 'Sharawat IK, Kasinathan A, Bansal A, Sahu JK, Sodhi KS, Dogra MR, Sankhyan N. Evaluation of Optic Nerve Sheath Diameter and Transcranial Doppler As Noninvasive Tools to Detect Raised Intracranial Pressure in Children. Pediatr Crit Care Med. 2020 Nov;21(11):959-965. doi: 10.1097/PCC.0000000000002523.'}, {'pmid': '18275454', 'type': 'BACKGROUND', 'citation': 'Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure. Acad Emerg Med. 2008 Feb;15(2):201-4. doi: 10.1111/j.1553-2712.2007.00031.x.'}]}, 'descriptionModule': {'briefSummary': 'Determination of high intracranial pressure (ICP) is necessary for the treatment of patients with raised ICP to improve long-term neurological outcomes. Ultrasonographic optic nerve sheath diameter (ONSD) measurement is a noninvasive, easily performed and cost effective technique for detecting high ICP.', 'detailedDescription': 'ICP measurements via ventricular catheters provide CSF drainage and ICP reduction. The normal ICP value is less than 15 mmHg in adults. In the literature the correlation of ONSD and invasive ICP measurements were determined. The aim of study is to evaluate the correlation of ONSD and direct ICP measurements and to determine cut off ONSD value to detect ICP ≥15 mmHg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-80 aged patients\n* With an external ventricular drainage catheter due to intracranial pathology\n\nExclusion Criteria:\n\n* Under the age of 18\n* Orbital tumors\n* Graves' disease\n* Exophthalmos\n* Sarcoidosis\n* Optic neuropathy\n* Meningitis\n* Ocular trauma\n* Lung diseases"}, 'identificationModule': {'nctId': 'NCT06367868', 'briefTitle': 'Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Evaluation of the Effect of Cerebrospinal Fluid Drainage on Optic Nerve Sheath Diameter in Patients Installed External Ventricular Drainage Catheter Due to Intracranial Pathology in the Intensive Care Unit', 'orgStudyIdInfo': {'id': 'E-83045809-604.01.02-179951'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Before Drainage', 'description': 'Optic nerve sheath diameter and intracranial pressure will be measured before CSF drainage', 'interventionNames': ['Procedure: After 5 ml CSF Drainage']}], 'interventions': [{'name': 'After 5 ml CSF Drainage', 'type': 'PROCEDURE', 'description': 'Optic Nerve Sheath Diameter and Intracranial Pressure measurements will be after 5 ml CSF drainage', 'armGroupLabels': ['Before Drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'state': 'Fatıh', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'GULSAH ORAK', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University - Cerrahpasa'}, {'name': 'OZLEM KORKMAZ DİLMEN', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul University - Cerrahpasa'}, {'name': 'EREN FATMA AKCİL', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor-Anesthesiology and Reanimation', 'investigatorFullName': 'Gülşah ORAK', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}