Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-02-25 @ 4:37 PM
Study NCT ID:
NCT02513628
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2015-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optic Nerve Sheath Diameter for Prediction of Outcome After Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-30', 'studyFirstSubmitDate': '2015-07-24', 'studyFirstSubmitQcDate': '2015-07-30', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': '3 months', 'description': 'participants will be followed for the duration of hospital stay, an expected average of 3 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac arrest', 'neuroprognostication', 'optic nerve sheath diameter', 'outcome', 'ultrasonography'], 'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Early prognostication in resuscitated cardiac arrest (CA) patients, within the first day after admission in the intensive care unit (ICU), remains difficult. Optic nerve sheath diameter (ONSD) measurement could predict increased intracranial pressure. Preliminary works showed that ONSD measurement could be used to predict outcome in post-CA patients.\n\nThe aim of this study was to assess the ability of bedside ONSD ultrasonographic measurement to predict survival and Cerebral Performance Category (CPC) score at hospital discharge in post-cardiac arrest patients treated with therapeutic hypothermia (TH).', 'detailedDescription': 'Prospective observational study including all consecutive successfully resuscitated and TH-treated CA patients without traumatic or neurological etiology of CA in two French ICUs. ONSD measurements were performed on day 1, 2, and 3 after return of spontaneous circulation (ONSD1,2,3 respectively).\n\nThe primary outcome is survival at hospital discharge (with an average follow-up of 3 month until ICU admission).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All unconscious (Glasgow Coma Scale ≤6) patients ≥18 years old, admitted in ICU after successful resuscitation from CA, and treated with TH targeted to 33°C were screened. Exclusion criteria were as follows: unavailable ONSD measurement within 24 hours after return of spontaneous circulation (unavailable investigator, early death, or major hemodynamic instability), traumatic or neurological origin of CA, previous cerebrovascular disease, facial trauma affecting the orbits and/or eyeballs, and previous history of ocular pathology such as exophthalmia, glaucoma or cataract.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unconscious (Glasgow Coma Scale ≤6)\n* ≥18 years old\n* Admitted in ICU after successful resuscitation from CA\n* Treated with TH targeted to 33°C\n\nExclusion Criteria:\n\n* unavailable ONSD measurement within 24 hours after return of spontaneous circulation (unavailable investigator, early death, or major hemodynamic instability)\n* Traumatic or neurological origin of CA\n* Previous cerebrovascular disease\n* Facial trauma affecting the orbits and/or eyeballs\n* Previous history of ocular pathology such as exophthalmia, glaucoma or cataract.'}, 'identificationModule': {'nctId': 'NCT02513628', 'acronym': 'ONSD-CA', 'briefTitle': 'Optic Nerve Sheath Diameter for Prediction of Outcome After Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Hopital of Melun'}, 'officialTitle': 'The Optic Nerve Sheath Diameter for Prediction of Outcome After Cardiac Arrest: a Pilot Prospective Study', 'orgStudyIdInfo': {'id': 'MelunH'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital of Melun', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Chelly Jonathan', 'investigatorAffiliation': 'Hopital of Melun'}}}}