Non-Invasive Monitoring Methods in Patients With Acute Brain Injury

Conditions

• Brain Injury, Acute

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

Life-threatening mass effect (LTME) arises when brain swelling displaces or compresses crucial midline structures subsequent to acute brain injuries (ABIs) like traumatic brain injury (TBI), ischemic stroke (IS), and intraparenchymal hemorrhage (IPH), which can manifest rapidly within hours or more gradually over days. Despite advancements in surgical management, significant gaps in understanding persist regarding optimal monitoring and therapeutic approaches. The current standard for identifying LTME involves neurologic decline in conjunction with radiographic evidence or increased intracranial pressure (ICP) indicating space-occupying mass effect. However, in critically ill patients, reliance on subjective physical exam findings, such as decreased arousal, often leads to delayed recognition, occurring only after catastrophic shifts have already occurred. The goal of this study is to determine the association of non-invasive biomarkers with neurologic deterioration, and to determine whether non-invasive biomarker inclusion improves detection of outcome and decline. The investigators propose to use various non-invasive methods to monitor ICP as adjuncts in detecting deteriorating mass effect. These methods include quantitative pupillometry, radiographic data, laboratory data, and other bedside diagnostic tests available including electroencephalography (EEG), skull vibrations detected via brain4care device, optic nerve sheath diameter assessment (ONSD), and ultrasound-guided eyeball compression. Some of these methods will be measured \*only\* for the purposes of the research study (such as skull vibrations via brain4care). Other measurements, such as quantitative pupillometry, will represent additional measurements beyond those already being collected for clinical care. This research study is necessary to understand the association of these non-invasive biomarkers with neurological decline and outcomes while considering potential confounding factors.

Key Dates

Start date

Sep 26, 2024

Status verified

Oct 2025

Primary completion

Sep 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

720 participants (estimated)

Arms

• Arm: NIMABI Group
  Eligible patients will be recruited on admission to the ICU followed by the Neurointensive care team. Demographic, invasive ICP monitoring data, clinical, laboratory, diagnostic, treatment (medical and surgical) and outcome data will be collected. Data will be collected from non-invasive devices using either clinical review from the chart, or if not available and/or used for additional measurements, from the device (smartguard for pupillometry, imaging, EEG data, Brain4care data).

Primary Outcome Measure

Neurologic Deterioration [ Time Frame: 5 years ]

Central Contacts

• Charlene Ong, MD MPHS
  617 638 5351
  [email protected]
• Leigh Mallinger, BA
  617-638-7732
  [email protected]

Locations (1)

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