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
Sponsors and collaborators
Braincare USA Corp
Lead sponsor
Universidade Federal de Sergipe
Collaborator
Federal University of São Paulo
Collaborator
Federal University of Amazonas
Collaborator