Nctid:
NCT06229782
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D001926", "term"=>"Brain Death"}, {"id"=>"D003643", "term"=>"Death"}], "ancestors"=>[{"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D003128", "term"=>"Coma"}, {"id"=>"D014474", "term"=>"Unconsciousness"}, {"id"=>"D003244", "term"=>"Consciousness Disorders"}, {"id"=>"D019954", "term"=>"Neurobehavioral Manifestations"}, {"id"=>"D009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M6845", "name"=>"Death", "asFound"=>"Death", "relevance"=>"HIGH"}, {"id"=>"M5203", "name"=>"Brain Death", "asFound"=>"Brain Death", "relevance"=>"HIGH"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M6356", "name"=>"Coma", "relevance"=>"LOW"}, {"id"=>"M17224", "name"=>"Unconsciousness", "relevance"=>"LOW"}, {"id"=>"M6468", "name"=>"Consciousness Disorders", "relevance"=>"LOW"}, {"id"=>"M21826", "name"=>"Neurobehavioral Manifestations", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>66}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2017-01-11", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2022-06-13", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-27", "studyFirstSubmitDate"=>"2024-01-08", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2022-01-25", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"ODUS", "timeFrame"=>"30 minutes", "description"=>"Orbital artery Doppler ultrasound (ODUS) ODUS measurements: T1; when brain death testing started; T2; 12 hours after the first measurement, T3; before CT angiography, T4; after CT angiography Peak systolic velocity (PSV) cm/s , end-diastolic velocity (EDV) cm/s measurement results. The absence of diastolic flow, reverse diastolic flow (oscillatory flow), and resistive index \\>1 were considered brain death."}, {"measure"=>"Resistive index (RI)", "timeFrame"=>"30 minutes", "description"=>"The resistive index (RI) is a calculated flow parameter in ultrasound, derived from the maximum, minimum, and mean Doppler frequency shifts during a defined cardiac cycle. Along with the pulsatility index (PI), it is typically used to assess the resistance in a pulsatile vascular system.resistive index \\>1 were considered brain death.\n\nRI measurements: T1; when brain death testing started; T2; 12 hours after the first measurement, T3; before CT angiography, T4; after CT angiography .\n\nRI = (PSV - EDV) / PSV\n\nPSV = peak systolic velocity and EDV = end-diastolic velocity."}], "secondaryOutcomes"=>[{"measure"=>"Transcranial Doppler ultrasound (TDUS)", "timeFrame"=>"30 minutes", "description"=>"Transcranial Doppler ultrasound (TDUS) ultrasonography involves the use of a low-frequency (≤2 MHz) transducer, placed on the scalp, to insonate the basal cerebral arteries through relatively thin bone windows and to measure the cerebral blood flow velocity (CBFV) normal flow: mean = 55cm/sec. mild: \\> 120cm/sec. moderate: \\> 160cm/sec. s"}, {"measure"=>"Cerebral blood flow (CTA)", "timeFrame"=>"40 minutes", "description"=>"Transcranial Computed Tomography Angiography"}, {"measure"=>"Optic nerve diameter", "timeFrame"=>"30 minutes", "description"=>"Optic nerve diameter (mm) Orbital artery Doppler was performed simultaneously with ultrasound. The imaging probe position was used transversely and axially and mean values were recorded."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Brain Death"]}, "descriptionModule"=>{"briefSummary"=>"Brain death is the irreversible loss of all activity in the brain, brainstem, and cerebellum, the part of the central nervous system that remains inside the skull.\n\nThe clinical diagnosis of brain death should be supported by ancillary tests that provide information about cerebral blood flow or electrical activity in the brain. Some of the ancillary tests that evaluate cerebral blood flow include transcranial Doppler ultrasonography (TDUS), computed tomography (CT) angiography (CTA), and catheter-based cerebral angiography.\n\nThis study hypothesized that Orbital Doppler ultrasonography (ODUS) alone is more effective than TDUS in detecting intracranial blood flow in diagnosing brain death. To this end, the investigators examined the results of ODUS in patients diagnosed as brain dead who underwent CT angiography."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"90 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* suspected brain death\n\nExclusion Criteria:\n\n* eye surgery,\n* uncontrolled diabetes mellitus,\n* facial trauma,\n* hypothermia,\n* hypotension (systolic pressure \\< 100 mm Hg)\n* endocrine-metabolic coma"}, "identificationModule"=>{"nctId"=>"NCT06229782", "briefTitle"=>"Orbital Artery Doppler Ultrasound in Brain Death", "organization"=>{"class"=>"OTHER_GOV", "fullName"=>"Bursa Yüksek İhtisas Education and Research Hospital"}, "officialTitle"=>"Orbital Artery Doppler Ultrasound as an Ancillary Test for Diagnosing Brain Death: a Prospective, Single Blind Comparative Study", "orgStudyIdInfo"=>{"id"=>"2017-15 /33"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"OTHER", "label"=>"ODUS", "description"=>"Orbital Doppler ultrasonography (ODUS)\n\nPatients in whom brain death was suspected and the diagnostic procedure was initiated underwent ODUS .ODUS were performed during the apnoea test and the first neurological examination. At the second neurological examination at 12 hours, ODUS were repeated.", "interventionNames"=>["Diagnostic Test: Orbital Doppler ultrasonography", "Diagnostic Test: Transcranial Doppler ultrasonography", "Diagnostic Test: Computed Tomography Angiography"]}], "interventions"=>[{"name"=>"Orbital Doppler ultrasonography", "type"=>"DIAGNOSTIC_TEST", "description"=>"During measurement, Doppler settings were adjusted to detect low flow and the smallest available Doppler gate was used for all ODUS examinations. The imaging probe position for ODUS was used transversely and axially, and mean values were recorded. ODUS 10-18 MHz linear probe was used.", "armGroupLabels"=>["ODUS"]}, {"name"=>"Transcranial Doppler ultrasonography", "type"=>"DIAGNOSTIC_TEST", "description"=>"During the measurement, Doppler settings were adjusted to detect low flow, and the minor available Doppler gate was used for all TDUS examinations. For TDUS, a temporal window was used approximately 1 cm above the midpoint of the line joining the lateral palpebral fissure and the external auditory meatus.\n\nTranscranial Doppler ultrasonography ( TDUS) 3-5 MHz convex array probe was used.", "armGroupLabels"=>["ODUS"]}, {"name"=>"Computed Tomography Angiography", "type"=>"DIAGNOSTIC_TEST", "description"=>"Cranial Computed Tomography Angiography", "armGroupLabels"=>["ODUS"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Bursa", "country"=>"Turkey", "facility"=>"University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,", "geoPoint"=>{"lat"=>40.19559, "lon"=>29.06013}}], "overallOfficials"=>[{"name"=>"Korgün Ökmen", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Korgün Ökmen", "class"=>"OTHER_GOV"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Korgün Ökmen", "investigatorAffiliation"=>"Bursa Yüksek İhtisas Education and Research Hospital"}}}}
