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NOT YET RECRUITING
NCT07210333

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

Sponsor: Braincare USA Corp

View on ClinicalTrials.gov

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

DEVICE

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