Clinical trial NCT06504238: Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
Official title: Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Injury, Acute
Keywords: Life-threatening mass effect (LIME)
Traumatic brain injury (TBI)
Ischemic stroke (IS)
Intraparenchymal hemorrhage (IPH)
Neurologic deterioration
Intracranial Pressure (ICP)
Glasgow Coma Scores
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be recruited on admission to the intensive care unit (ICU) at Boston Medica Center followed by the Neurointensive care team.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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
* Anticipated stay \>24 hours

Exclusion Criteria:

* Comfort measure only
* Any other criteria that the PI deems that makes the patient inadequate for the study
* Sub-exclusion criteria for specific non-invasive measurements include:

  * Orbital injury (pupillometry, ONSD)
  * Traumatic injury or surgery that precludes use of B4C device
* Presence of supratentorial craniectomy or craniotomy that has not healed and is mobile/bone defects/scalp injury \[EEGelectroencephalogram (EEG), Brain4Care\]
* Presence of extensive scalp injury

Primary outcomes:
measure: Neurologic Deterioration
timeFrame: 5 years
measure: Glasgow Coma Scores
timeFrame: 5 years
Secondary outcomes:
measure: Number of participant deaths during hospitalization
timeFrame: 5 years
measure: Functional outcome at hospital discharge
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Neurology
name: Charlene Ong, MD MPHS
role: PRINCIPAL_INVESTIGATOR
References: