Non-Invasive Triage for Intracranial Hypertension in Prehospital Care
Starting soon · Not applicable
Conditions studied: Intracranial Hypertension, Acute Brain Injury, Stroke, Traumatic Brain Injury, Subarachnoid Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT07747636
- Run by
- Juliana Caldas
- People needed
- 180
- Starts
- 2026-09-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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;
- Agitated, aggressive, or uncooperative individuals whose condition prevents follow-up and outcome assessment;
- Pregnant women.
Full record on ClinicalTrials.gov
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