Non-Invasive Triage for Intracranial Hypertension in Prehospital Care

Official title

Implementation of Non-Invasive Triage for Intracranial Hypertension Assessment in Prehospital Care

Overview

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

• Device Brain4care 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 test Optic 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.

Primary outcome measures

• Proportion of patients correctly referred to a hospital with neurosurgical capability [Time frame: From prehospital assessment (Phase 2) up to hospital admission and determination of neurosurgical need, assessed within 24 hours of hospital arrival]

Secondary outcome measures (6)

• Time from first medical contact to definitive neurosurgical intervention [Time frame: From first prehospital contact until neurosurgical intervention, up to 30 days]
• 30-day mortality [Time frame: 30 days after the acute brain injury event]
• Functional outcome at 90 days (modified Rankin Scale) [Time frame: 90 days after the acute brain injury event]
• Length of hospital stay [Time frame: From hospital admission to discharge, assessed up to 180 days]
• Adverse events related to use of the B4C device and ONSD ultrasound [Time frame: From prehospital assessment until hospital admission, assessed up to 24 hours]
• Cost-effectiveness of B4C/ONSD-assisted prehospital triage [Time frame: From prehospital assessment through hospital discharge, assessed up to 180 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07747636 · 89168125.1.0000.0040 · 89168125.1.0000.0040

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗