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Non-Invasive Triage for Intracranial Hypertension in Prehospital Care

NCT07747636 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-08-05

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Brain4care non-invasive intracranial pressure monitor

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.

DIAGNOSTIC_TEST

Optic nerve sheath diameter ultrasound

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.

Sponsors & Collaborators

  • Juliana Caldas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-01-31
Completion
2027-03-31
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07747636 on ClinicalTrials.gov