Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
ConditionBrain Injury, Acute
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admitted under Neuro intensivist primary or consultative care.
At least one head computed tomography (CT) scan demonstrating intracranial pathology that may lead to life-threatening mass effect (i.e. traumatic brain injury, ischemic or hemorrhagic stroke, epidural or subdural hematoma, subarachnoid hemorrhage, diffuse hypoxic injury, metabolic cerebral edema, tumor)
Concern for Life Threatening Mass Effect
Glasgow Coma Score (GCS) <9
Disqualifiers
Comfort measure only
Any other criteria that the PI deems that makes the patient inadequate for the study
Orbital injury (pupillometry, ONSD)
Traumatic injury or surgery that precludes use of B4C device
Trial population
Eligible patients will be recruited on admission to the intensive care unit (ICU) at Boston Medica Center followed by the Neurointensive care team.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
720 Participants
are grouped into 1 trial groupGroup A: NIMABI Group
Trial outcomes
Primary outcomes
1
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.
Time frame
5 years2
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.
Time frame
5 yearsSecondary outcomes
1
Number of participant deaths during hospitalization
This data will be abstracted from medical records..
Time frame
5 years2
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.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov