[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650472":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":12,"centralContacts":31,"locations":12,"responsibleParty":37,"collaborators":12,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":12,"enrollmentInfo":51,"targetDuration":12,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":72,"whyStopped":12,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":12},{"fullName":5,"class":6},"Escola Bahiana de Medicina e Saude Publica","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Prehospital Care","NO_INTERVENTION","Participants receive standard prehospital assessment and care according to current SAMU protocols. Clinical and neurological evaluation and the decision to refer the patient to a hospital (with or without neurosurgical capability) are based on standard clinical and operational criteria, without use of the Brain4care device or optic nerve sheath diameter ultrasound.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"B4C\u002FONSD-Assisted Triage","EXPERIMENTAL","In addition to standard prehospital assessment, participants are evaluated using the Brain4care (B4C) non-invasive intracranial pressure monitor and ultrasound measurement of optic nerve sheath diameter (ONSD). The decision to prioritize transport to a hospital with neurosurgical capability takes into account the results of these non-invasive assessments alongside standard clinical criteria.",[18,19],"Device: Brain4care non-invasive intracranial pressure monitor","Diagnostic Test: Optic nerve sheath diameter ultrasound",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":12},"DEVICE","Brain4care non-invasive intracranial pressure monitor","A wearable, non-invasive sensor (FDA 510(k) cleared, K240821) placed on the scalp that detects micrometric skull deformations associated with fluctuations in intracranial pressure. The device analyzes the pulse waveform morphology to estimate intracranial compliance and infer changes in intracranial pressure, without requiring any invasive procedure. Application time is estimated at up to 5 minutes.",[14],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":12},"DIAGNOSTIC_TEST","Optic nerve sheath diameter ultrasound","A point-of-care ultrasound measurement of the diameter of the optic nerve sheath, which correlates with intracranial pressure. Although it does not provide an absolute measurement of intracranial pressure, an enlarged optic nerve sheath diameter is a recognized bedside indicator of intracranial hypertension.",[14],[32],{"name":33,"role":34,"phone":35,"phoneExt":12,"email":36},"Davi J Fontoura Solla, PhD","CONTACT","+55 71 9978-1989","davisolla@hotmail.com",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Juliana Caldas","Adjunct Professor","100650472","non-invasive-triage-for-intracranial-hypertension-in-prehospital-care-100650472",false,"NCT07747636","Non-Invasive Triage for Intracranial Hypertension in Prehospital Care","Implementation of Non-Invasive Triage for Intracranial Hypertension Assessment in Prehospital Care","B4C-APH","Inclusion Criteria:\n\n* Age 18 years or older\n* Attended by the Mobile Emergency Care Service (SAMU) in the metropolitan area of Salvador, Brazil\n* Clinical presentation suggestive of acute stroke (sudden focal neurological deficit or sudden and severe headache) OR moderate\u002Fsevere traumatic brain injury (Glasgow Coma Scale)\n\nExclusion Criteria:\n\n* Individuals with brain injuries of other etiologies, such as prior traumatic brain injury (TBI) and\u002For stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, and illicit drug use;\n* Individuals with scalp and\u002For skin lacerations that prevent positioning of the brain4care sensor;\n* Individuals with craniectomy;\n* Severe debilitating mental health disorders and\u002For severe debilitating neurological diseases;\n* Agitated, aggressive, or uncooperative individuals whose condition prevents follow-up and outcome assessment;\n* Pregnant women.","ALL","18 Years",{"count":52,"type":53},180,"ESTIMATED","INTERVENTIONAL",[56],"NA","This study tests whether two non-invasive tools can help paramedics detect dangerously high pressure inside the skull in patients with a sudden brain injury, such as stroke or head trauma, before they reach the hospital.\n\nThe tools are a wearable sensor called Brain4care, placed on the head, and an ultrasound measurement of the eye's optic nerve. Neither tool requires needles, incisions, or any invasive procedure.\n\nThe study has two parts. In the first part, researchers will use both tools on patients treated by the Mobile Emergency Care Service (SAMU) in Salvador, Brazil, to check how accurately the tools can detect high pressure inside the skull. The results from these tools will not be used to guide the patient's care during this part of the study.\n\nIn the second part, some patients will be assessed using these tools as part of their emergency care, while other patients will receive standard emergency care. Researchers will compare how often each group of patients is correctly sent to a hospital with the specialized brain surgery services they may need.\n\nThe goal of this research is to help emergency teams identify patients with dangerous brain pressure earlier and get them to the right hospital faster, which may improve their chances of recovery.",[59,60,61,62,63],"Intracranial Hypertension","Acute Brain Injury","Stroke","Traumatic Brain Injury","Subarachnoid Hemorrhage",[65,66,67,68,69,70,71],"Non-invasive intracranial pressure monitoring","Brain4care","Optic nerve sheath diameter","Prehospital triage","Emergency medical services","Neurocritical care","Intracranial pressure waveform","NOT_YET_RECRUITING","2026-07-31",{"date":75,"type":76},"2026-08-05","ACTUAL",{"date":78,"type":53},"2026-09-01",{"date":80,"type":53},"2027-03",{"name":39,"class":6}]