Non-Invasive Triage for Intracranial Hypertension in Prehospital Care (NCT07747636) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Non-Invasive Triage for Intracranial Hypertension in Prehospital Care
180 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is about using a non-invasive tool to decide where to send someone with a suspected brain emergency before they even reach the hospital — how does that kind of prehospital triage work, and could it affect which hospital I or a loved one gets taken to in an emergency?
2Since this study isn't recruiting yet, how far away is it from starting, and is there any way to be notified or considered once it does open?
3The trial is measuring how often patients get correctly sent to a hospital that can do neurosurgery — what happens right now, without this tool, if someone with a condition like mine arrives at a hospital that doesn't have that capability?
4This is a triage and routing study, not a treatment trial — does that mean it wouldn't change the actual medical treatment I receive, only where I receive it, and would my care team still make all the treatment decisions once I arrived?
5Given that this study covers several serious conditions including traumatic brain injury, stroke, and subarachnoid hemorrhage, would the standard emergency pathway already get me to the right level of care, or is there a real gap this trial is trying to address that I should understand?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients correctly referred to a hospital with neurosurgical capability
Timeframe: From prehospital assessment (Phase 2) up to hospital admission and determination of neurosurgical need, assessed within 24 hours of hospital arrival