Acute Brain Injury, Intracranial Hypertension, Stroke, Subarachnoid Hemorrhage, Traumatic Brain Injury
Conditions
Keywords
Non-invasive intracranial pressure monitoring, Brain4care, Optic nerve sheath diameter, Prehospital triage, Emergency medical services, Neurocritical care, Intracranial pressure waveform
Brief summary
This study tests whether two non-invasive tools can help paramedics detect dangerously high pressure inside the skull in patients with a sudden brain injury, such as stroke or head trauma, before they reach the hospital. The tools are a wearable sensor called Brain4care, placed on the head, and an ultrasound measurement of the eye's optic nerve. Neither tool requires needles, incisions, or any invasive procedure. The study has two parts. In the first part, researchers will use both tools on patients treated by the Mobile Emergency Care Service (SAMU) in Salvador, Brazil, to check how accurately the tools can detect high pressure inside the skull. The results from these tools will not be used to guide the patient's care during this part of the study. In the second part, some patients will be assessed using these tools as part of their emergency care, while other patients will receive standard emergency care. Researchers will compare how often each group of patients is correctly sent to a hospital with the specialized brain surgery services they may need. The goal of this research is to help emergency teams identify patients with dangerous brain pressure earlier and get them to the right hospital faster, which may improve their chances of recovery.
Detailed description
Acute brain injuries, including hemorrhagic and ischemic stroke and traumatic brain injury, are leading causes of death and disability worldwide and in Brazil. A common and dangerous complication of these injuries is intracranial hypertension (elevated pressure inside the skull), which can cause irreversible brain damage if not identified and treated promptly. Currently, there is no reliable, non-invasive method to assess intracranial pressure in the prehospital setting, which can delay referral to hospitals with neurosurgical capability. This study evaluates two non-invasive technologies for prehospital triage: the Brain4care (B4C) device, a wearable extensometer that detects micrometric skull deformations associated with intracranial pressure fluctuations, and ultrasound measurement of the optic nerve sheath diameter (ONSD), which correlates with intracranial pressure. The study is conducted in two sequential phases by the Mobile Emergency Care Service (SAMU) in the metropolitan area of Salvador, Brazil. Phase 1 is a prospective, blinded, observational proof-of-concept study in adult patients with suspected acute brain injury (stroke or moderate/severe traumatic brain injury). Both B4C and ONSD will be applied to all eligible patients, but results will not be used for clinical decision-making. Investigators interpreting reference-standard neuroimaging or invasive intracranial pressure monitoring will be blinded to the B4C and ONSD results. This phase will assess the diagnostic accuracy and operational feasibility of both methods in the prehospital environment. Phase 2 is an open-label, randomized, controlled, parallel-group clinical trial. Eligible patients will be randomized to standard prehospital care (control group) or prehospital triage assisted by B4C and ONSD (intervention group). The primary outcome is the proportion of patients correctly referred to hospitals with neurosurgical capability. Secondary outcomes include time to neurosurgical intervention, 30-day mortality, 90-day functional outcome, length of hospital stay, adverse events, and cost-effectiveness. This project was approved by the Research Ethics Committee of the Gonçalo Moniz Research Center - Fiocruz Bahia (CEP Opinion No. 8,050,683).
Interventions
DEVICEBrain4care non-invasive intracranial pressure monitor
A wearable, non-invasive sensor (FDA 510(k) cleared, K240821) placed on the scalp that detects micrometric skull deformations associated with fluctuations in intracranial pressure. The device analyzes the pulse waveform morphology to estimate intracranial compliance and infer changes in intracranial pressure, without requiring any invasive procedure. Application time is estimated at up to 5 minutes.
DIAGNOSTIC_TESTOptic nerve sheath diameter ultrasound
A point-of-care ultrasound measurement of the diameter of the optic nerve sheath, which correlates with intracranial pressure. Although it does not provide an absolute measurement of intracranial pressure, an enlarged optic nerve sheath diameter is a recognized bedside indicator of intracranial hypertension.
Sponsors
Juliana Caldas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Phase 2 is open-label. In Phase 1, outcomes assessors interpreting reference-standard neuroimaging or invasive intracranial pressure monitoring were blinded to the B4C and ONSD results.
Intervention model description
This study has two sequential phases. Phase 1 is a single-group observational proof-of-concept study (n=60) assessing the diagnostic accuracy of the B4C and ONSD methods, with no influence on clinical care. Phase 2 is a parallel-group randomized controlled trial (n=120) comparing standard prehospital care to B4C/ONSD-assisted triage.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Attended by the Mobile Emergency Care Service (SAMU) in the metropolitan area of Salvador, Brazil * Clinical presentation suggestive of acute stroke (sudden focal neurological deficit or sudden and severe headache) OR moderate/severe traumatic brain injury (Glasgow Coma Scale)
Exclusion criteria
* Individuals with brain injuries of other etiologies, such as prior traumatic brain injury (TBI) and/or stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, and illicit drug use; * Individuals with scalp and/or skin lacerations that prevent positioning of the brain4care sensor; * Individuals with craniectomy; * Severe debilitating mental health disorders and/or severe debilitating neurological diseases; * Agitated, aggressive, or uncooperative individuals whose condition prevents follow-up and outcome assessment; * Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients correctly referred to a hospital with neurosurgical capability | From prehospital assessment (Phase 2) up to hospital admission and determination of neurosurgical need, assessed within 24 hours of hospital arrival | Proportion of patients appropriately directed to a hospital with neurosurgical support, based on imaging findings and/or the need for neurosurgical intervention, compared between the intervention (B4C/ONSD-assisted triage) and control (standard prehospital care) groups. This outcome assesses whether non-invasive triage reduces both under-referral (patients needing neurosurgery sent to centers without this capability) and over-referral (unnecessary burden on specialized centers). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from first medical contact to definitive neurosurgical intervention | From first prehospital contact until neurosurgical intervention, up to 30 days | Time elapsed between first prehospital medical contact and definitive neurosurgical intervention (when indicated), compared between patients triaged with and without the assistance of the B4C and ONSD devices. |
| 30-day mortality | 30 days after the acute brain injury event | All-cause mortality within 30 days after the acute brain injury event, compared between patients triaged with and without the assistance of the B4C and ONSD devices. |
| Functional outcome at 90 days (modified Rankin Scale) | 90 days after the acute brain injury event | Functional status assessed using the modified Rankin Scale (mRS), a 7-point scale ranging from 0 (no symptoms) to 6 (death), evaluated 90 days after the acute brain injury event and compared between patients triaged with and without the assistance of the B4C and ONSD devices. |
| Length of hospital stay | From hospital admission to discharge, assessed up to 180 days | Total duration of hospitalization, from admission to discharge, compared between patients triaged with and without the assistance of the B4C and ONSD devices. |
| Adverse events related to use of the B4C device and ONSD ultrasound | From prehospital assessment until hospital admission, assessed up to 24 hours | Number and proportion of participants experiencing adverse events related to the application of the Brain4care device or optic nerve sheath diameter ultrasound during prehospital care, including minor discomfort during sensor application or any delay in care attributable to device use. |
| Cost-effectiveness of B4C/ONSD-assisted prehospital triage | From prehospital assessment through hospital discharge, assessed up to 180 days | Cost-effectiveness analysis of implementing B4C/ONSD-assisted triage compared to standard prehospital care, considering direct and indirect costs associated with patient care, including transport, hospitalization, and neurosurgical intervention. |
Contacts
CONTACTDavi J Fontoura Solla, PhD
Outcome results
None listed