About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Brain4care non-invasive intracranial pressure monitor
- Optic nerve sheath diameter ultrasound
Treatment groups
Locations
Sponsors and collaborators
Juliana Caldas
Lead sponsor
Escola Bahiana de Medicina e Saude Publica
Sponsor institution