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Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System
Sponsor: Braincare USA Corp
Summary
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?
Official title: Evaluation and Enhancement of the Effectiveness of Non-invasive Intracranial Pressure Monitoring for Screening in Neurological Emergencies Within the Brazilian Unified Health System
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2025-12-16
Completion Date
2028-01-28
Last Updated
2025-10-07
Healthy Volunteers
No
Interventions
non-invasive intracranial pressure monitoring
non-invasive intracranial pressure monitoring that provides continuous bedside monitoring.
Locations (3)
Hospital Universitário Getúlio Vargas
Manaus, Amazonas, Brazil
Hospital Universitário de Lagarto
Lagarto, Sergipe, Brazil
Hospital São Paulo
São Paulo, São Paulo, Brazil