Non-Invasive Triage for Intracranial Hypertension in Prehospital Care

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuliana Caldas

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Brain4care non-invasive intracranial pressure monitor
  • Optic nerve sheath diameter ultrasound

Treatment groups

180 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Juliana Caldas

Lead sponsor

Escola Bahiana de Medicina e Saude Publica

Sponsor institution