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.
Age 18 years or older
Attended by the Mobile Emergency Care Service (SAMU) in the metropolitan area of Salvador, Brazil
Clinical presentation suggestive of acute stroke (sudden focal neurological deficit or sudden and severe headache) OR moderate/severe traumatic brain injury (Glasgow Coma Scale)
Individuals with brain injuries of other etiologies, such as prior traumatic brain injury (TBI) and/or stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, and illicit drug use;
Individuals with scalp and/or skin lacerations that prevent positioning of the brain4care sensor;
Individuals with craniectomy;
Severe debilitating mental health disorders and/or severe debilitating neurological diseases;
Parallel
Brain4care non-invasive intracranial pressure monitor
DeviceA 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.
Optic nerve sheath diameter ultrasound
Diagnostic testA 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.
Proportion of patients correctly referred to a hospital with neurosurgical capability
Proportion of patients appropriately directed to a hospital with neurosurgical support, based on imaging findings and/or the need for neurosurgical intervention, compared between the intervention (B4C/ONSD-assisted triage) and control (standard prehospital care) groups. This outcome assesses whether non-invasive triage reduces both under-referral (patients needing neurosurgery sent to centers without this capability) and over-referral (unnecessary burden on specialized centers).
Time from first medical contact to definitive neurosurgical intervention
Time elapsed between first prehospital medical contact and definitive neurosurgical intervention (when indicated), compared between patients triaged with and without the assistance of the B4C and ONSD devices.
30-day mortality
All-cause mortality within 30 days after the acute brain injury event, compared between patients triaged with and without the assistance of the B4C and ONSD devices.
Functional outcome at 90 days (modified Rankin Scale)
Functional status assessed using the modified Rankin Scale (mRS), a 7-point scale ranging from 0 (no symptoms) to 6 (death), evaluated 90 days after the acute brain injury event and compared between patients triaged with and without the assistance of the B4C and ONSD devices.
Length of hospital stay
Total duration of hospitalization, from admission to discharge, compared between patients triaged with and without the assistance of the B4C and ONSD devices.
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Juliana Caldas
Lead sponsor
Escola Bahiana de Medicina e Saude Publica
Sponsor institution
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