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.
The 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.
The 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.
In 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.
The 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.
Inclusion Criteria:
Exclusion Criteria:
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Phase 2 is open-label. In Phase 1, outcomes assessors interpreting reference-standard neuroimaging or invasive intracranial pressure monitoring were blinded to the B4C and ONSD results.
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.
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.
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