Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
NCT Number: NCT06504238
Acronym: NIMABI
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Brain Injury, Acute
Sponsor: Boston Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 720
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2030-09
Locations: Boston Medical Center, Boston, Massachusetts, 02118, United States

Summary:
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.

Primary Outcome Measures: Neurologic Deterioration, Neurologic deterioration will be assessed as a dichotomous variable (yes/no) defined as a negative change in any of the following: level of consciousness, agaze, arm motor function, leg motor function, or language. The participants' medical chart will be reviewed for documentation of persistent change., 5 years|Glasgow Coma Scores, The Glasgow Coma Scale (GCS) is a 15-point scale used to evaluate a person's state of consciousness. A score of 3 is the lowest possible and indicates a deep coma or death, while a score of 15 is the highest and indicates a fully awake person. A lower score generally means a deeper coma., 5 years
Secondary Outcome Measures: Number of participant deaths during hospitalization, This data will be abstracted from medical records.., 5 years|Functional outcome at hospital discharge, This will be assessed by Modified Rankin Scale (mRS), a 6 point disability scale with possible scores ranging from 0 to 5, higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence. A separate category of 6 is usually added for patients who expire. Data will be abstracted from medical records on review of patient notes and discharge summaries to obtain amRS for each participant., 5 years