NCT07747636Not yet recruiting
Non-Invasive Triage for Intracranial Hypertension in Prehospital Care
Implementation of Non-Invasive Triage for Intracranial Hypertension Assessment in Prehospital Care
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 30 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Juliana Caldas
- Diseases
- Stroke, High blood pressure
- NCT number
- NCT07747636
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 1 Sept 2026 to the primary completion date, Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Severe debilitating mental health disorders and/or severe debilitating neurological diseases;
- Agitated, aggressive, or uncooperative individuals whose condition prevents follow-up and outcome assessment;
Other
- Individuals with scalp and/or skin lacerations that prevent positioning of the brain4care sensor;
- Individuals with craniectomy;
- Pregnant women.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.