Non-Invasive Triage for Intracranial Hypertension in Prehospital Care

Sponsor
Juliana Caldas
Study ID
NCT07747636
Status
Not Yet Recruiting

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Conditions

  • Acute Brain Injury
  • Intracranial Hypertension
  • Stroke
  • Subarachnoid Hemorrhage
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brain4care non-invasive intracranial pressure monitor — DEVICE
    A 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_TEST
    A 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.

Study Details

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 Dates

First listed
Aug 5, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • No Intervention: Standard Prehospital Care
    Participants receive standard prehospital assessment and care according to current SAMU protocols. Clinical and neurological evaluation and the decision to refer the patient to a hospital (with or without neurosurgical capability) are based on standard clinical and operational criteria, without use of the Brain4care device or optic nerve sheath diameter ultrasound.
  • Experimental: B4C/ONSD-Assisted Triage
    In addition to standard prehospital assessment, participants are evaluated using the Brain4care (B4C) non-invasive intracranial pressure monitor and ultrasound measurement of optic nerve sheath diameter (ONSD). The decision to prioritize transport to a hospital with neurosurgical capability takes into account the results of these non-invasive assessments alongside standard clinical criteria.

Primary Outcome Measure

Proportion of patients correctly referred to a hospital with neurosurgical capability [ Time Frame: From prehospital assessment (Phase 2) up to hospital admission and determination of neurosurgical need, assessed within 24 hours of hospital arrival ]

Central Contacts

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