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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adult patients (≥18 years) of both sexes presenting with clinical signs and symptoms of traumatic brain injury (mild, moderate, or severe) or stroke (ischemic or hemorrhagic). Participants will be recruited from multiple levels of care within the Brazilian Unified Health System (SUS), including primary care units (UBS), urgent care units (UPA), pre-hospital emergency services (SAMU), hospital emergency rooms (PS), and intensive care units (ICUs) at participating hospitals in the states of Amazonas, São Paulo, Sergipe, and Rio Grande do Sul.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
non-invasive intracranial pressure monitoring
Devicenon-invasive intracranial pressure monitoring that provides continuous bedside monitoring.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Traumatic Brain Injury1 intervention
Group B: Stroke1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of non-invasive ICP and compliance parameters
Diagnostic accuracy of non-invasive ICP and compliance parameters (P2/P1 ratio, nTTP) obtained with the brain4care system for detecting intracranial hypertension, assessed by sensitivity, specificity, predictive values, and ROC curve analysis, using neuroimaging and clinical evaluation as reference standards.
Time frame
From enrollment up to 14 days in the intensive care unit.Secondary outcomes
1
Correlation of non-invasive ICP/ICC parameters with clinical and imaging findings in TBI and stroke patients
Correlation of non-invasive ICP/ICC parameters with clinical and imaging findings in TBI and stroke patients, including CT-based scales (Marshall, Rotterdam, ASPECTS, Fisher, STICH, CRASH) and neurological scales (Glasgow Coma Scale, NIHSS, Hunt-Hess, WFNS, Rankin).
Time frame
From enrollment up to 14 days in the intensive care unit.Other outcomes
1
Differentiation of ischemic vs. hemorrhagic stroke
Differentiation of ischemic vs. hemorrhagic stroke using brain4care non-invasive ICP waveform morphology (P2/P1 ratio, nTTP) compared to imaging and clinical reference standards.
Time frame
From enrollment up to 14 days in the intensive care unit.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Braincare USA Corp
Lead sponsor
Universidade Federal de Sergipe
Collaborator
Federal University of São Paulo
Collaborator
Federal University of Amazonas
Collaborator
Source ClinicalTrials.gov
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