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Non-Invasive Monitoring Methods in Patients With Acute Brain Injury

Recruitingn/aAges 18 Years - anyAllBoston Medical Center
NCT06504238 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Life-threatening mass effect (LTME) arises when brain swelling displaces or compresses crucial midline structures subsequent to acute brain injuries (ABIs) like traumatic brain injury (TBI), ischemic stroke (IS), and intraparenchymal hemorrhage (IPH), which can manifest rapidly within hours or more gradually over days. Despite advancements in surgical management, significant gaps in understanding persist regarding optimal monitoring and therapeutic approaches. The current standard for identifying LTME involves neurologic decline in conjunction with radiographic evidence or increased intracranial pressure (ICP) indicating space-occupying mass effect. However, in critically ill patients, reliance on subjective physical exam findings, such as decreased arousal, often leads to delayed recognition, occurring only after catastrophic shifts have already occurred. The goal of this study is to d

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📋 Eligibility rules (as published)
Inclusion Criteria: * Admitted under Neuro intensivist primary or consultative care. * At least one head computed tomography (CT) scan demonstrating intracranial pathology that may lead to life-threatening mass effect (i.e. traumatic brain injury, ischemic or hemorrhagic stroke, epidural or subdural hematoma, subarachnoid hemorrhage, diffuse hypoxic injury, metabolic cerebral edema, tumor) * Concern for Life Threatening Mass Effect * Glasgow Coma Score (GCS) \<9 * Anticipated stay \>24 hours Exclusion Criteria: * Comfort measure only * Any other criteria that the PI deems that makes the patient inadequate for the study * Sub-exclusion criteria for specific non-invasive measurements include: * Orbital injury (pupillometry, ONSD) * Traumatic injury or surgery that precludes use of B4C device * Presence of supratentorial craniectomy or craniotomy that has not healed and is mobile/bone defects/scalp injury \[EEGelectroencephalogram (EEG), Brain4Care\] * Presence of extensive scalp injury
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What it tests

  • Not listed
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Where

1 site
Boston Medical Center
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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