Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBraincare USA Corp

About this trial

The goal of this observational study is to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) pulse morphology and associated parameters (such as the P2/P1 ratio and nTTP) obtained with the brain4care system for the screening of intracranial hypertension (ICH) in patients with traumatic brain injury (TBI) and stroke treated in Brazil's public health system (SUS).

The main questions it aims to answer are:

Can non-invasive ICP and ICC pulse morphology reliably identify or exclude intracranial hypertension, cerebral edema, and hemorrhage compared to CT findings and clinical/neurological evaluations?

Can this approach differentiate ischemic stroke from hemorrhagic stroke with sufficient accuracy?

Does the use of brain4care contribute to earlier detection, improved clinical decision-making, and cost reduction in emergency settings?

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • non-invasive intracranial pressure monitoring

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Braincare USA Corp

Lead sponsor

Universidade Federal de Sergipe

Collaborator

Federal University of São Paulo

Collaborator

Federal University of Amazonas

Collaborator