Brain Monitoring Device for ICU Patients
Recruiting in Palo Alto (17 mi)
Overseen ByNeha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the clinical utility of Neurosteer's brain monitoring platform for monitoring delirium, sedation, and agitation in intubated and sedated ICU patients. The research team will be conducting a single-site study. The research team will enroll 100 patients admitted to the NSICU. 50 of these patients will have Acute Neurological Injuries (ANI) and the other 50 will not have an ANI. All enrolled patients will receive the intervention, the Neurosteer brain monitoring device.
The study intervention consists of the use of Neurosteer's innovative single-channel EEG monitoring device to determine if there is a good correlation and agreement between their signals/parameters to RASS, CAM-ICU, and continuous EEG monitoring readings. The Neurosteer device will be attached to their forehead and readings will be collected for the duration of their NSICU stay. The research team will adapt the current physical methods of detecting the depth of anesthesia i.e. through the Richmond Agitation-Sedation Scale (RASS) \& CAM-ICU, to auditory stimulation, which will be delivered through earphones with no physical contact, with the aim of achieving a high correlation between the methods. RASS and CAM-ICU will be collected hourly as standard of care and Neurosteer auditory stimulation will be done 3-4 times a day to coincide with RASS and 1-2 times a day to coincide with CAM-ICU. The research team will correlate collected hourly RASS and CAM-ICU assessments with Neurosteer derived signals and parameters.
What data supports the effectiveness of the Neurosteer Bedside Monitoring System for ICU patients?
Research shows that continuous EEG monitoring, like the Neurosteer system, can detect seizure activity and other brain function abnormalities in ICU patients, which helps in making better medical decisions. Similar EEG systems have been effective in monitoring brain activity and predicting outcomes in various critical care settings.
278910Is the Neurosteer Brain Monitoring Device safe for use in humans?
The research articles reviewed do not provide specific safety data for the Neurosteer Brain Monitoring Device or its variants. However, they discuss the use of EEG monitoring devices in intensive care settings, indicating that such devices are generally used safely for continuous brain monitoring in critically ill patients.
3561011How is the Neurosteer Bedside Monitoring System different from other treatments for ICU patients?
The Neurosteer Bedside Monitoring System is unique because it offers a single-channel EEG (electroencephalography) monitoring device that is portable and can be used at the bedside, making it more accessible and easier to use compared to traditional multi-channel EEG systems that require more complex setup and interpretation.
145710Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants are expected to be on sedative drips like propofol, midazolam, or fentanyl, so you may need to continue those if applicable.
Eligibility Criteria
This trial is for ICU patients, both with and without acute neurological injuries (ANI), who are intubated and sedated. It aims to include a total of 100 participants, split evenly between those with ANI and those without.Inclusion Criteria
I am 18 years old or older.
I am on a ventilator and expected to stay in the hospital for at least 2 days on sedatives.
Exclusion Criteria
I have severe memory loss that affects my daily life.
Participant Groups
The study tests Neurosteer's EEG device designed to monitor brain activity related to delirium, sedation, and agitation. All patients will use the device which will be compared against standard monitoring scales like RASS & CAM-ICU.
2Treatment groups
Active Control
Group I: NSICU Patients with Acute Neurological Injuries (ANI)Active Control1 Intervention
ANI are participants having Acute Ischemic Stroke (AIS), Intracerebral Hemorrhage, Subarachnoid Hemorrhage (SAH), Status Epileptics, Traumatic Brain Injury (TBI), Brain Tumors, Meningitis/encephalitis, post cardiac arrest hypoxic ischemic encephalopathy. All participants will be set up with the Neurosteer bedside monitoring system.
Group II: NSICU Patients without Acute Neurological Injuries (ANI)Active Control1 Intervention
Participants without ANI to have neuromuscular disorders such as myasthenia gravis, spine surgery, septic shock, acute respiratory distress syndrome, and Hemorrhagic shock ex. from gastrointestinal bleeding. All participants will be set up with the Neurosteer bedside monitoring system.
Neurosteer Bedside Monitoring System is already approved in United States for the following indications:
🇺🇸 Approved in United States as Neurosteer Bedside Monitoring System for:
- Monitoring delirium, sedation, and agitation in intubated and sedated ICU patients
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Mount Sinai HospitalNew York, NY
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
Neurosteer Ltd.Industry Sponsor
References
Electrophysiologic monitoring in the intensive care unit. [2015]Electroencephalography (EEG) and evoked potential studies are established monitoring tools in the neurological intensive care unit (ICU). These neurophysiologic techniques provide information on physiological state and response to therapy, and may aid diagnosis and prognosis. Serial studies or continuous monitoring may enable changes to be detected prior to irreversible deterioration in the patient's condition. Current computer technology allows simultaneous display and correlation of electrophysiologic parameters, cardiovascular state and intracranial pressure (ICP). Continuous EEG monitoring in the ICU has been shown to have a decisive or contributing impact on medical decision making in more than three-quarters of patients. In addition, continuous EEG monitoring has revealed previously unsuspected non-convulsive seizures in one-third of patients. SEPs and BAEPs can provide useful prognostic information in coma-however, these tests are etiologically nonspecific and must be carefully integrated into the clinical situation. Motor evoked potentials offer a potentially useful tool for evaluating motor system abnormalities in the ICU.
Continuous EEG and evoked potential monitoring in the neuroscience intensive care unit. [2022]As with other methods long used in intensive care units (ICU) and operating rooms (OR), the goal of neuroscience ICU continuous EEG (NICU-CEEG) and evoked potential (NICU-EP) monitoring is to extend our powers of observation to detect abnormalities at a reversible stage. EEG is an appropriate monitoring tool because it is linked to cerebral metabolism, is sensitive to ischemia and hypoxemia, correlates with cerebral topography, detects neuronal dysfunction at a reversible stage, and is the best method for detecting seizure activity. When applied systematically, it can impact medical decision-making in 81% of monitored patients. It is useful in monitoring precarious cerebral perfusion at the bedside, and it has revealed that nonconvulsive seizures, undetectable otherwise, occur in 34% of NICU patients. In convulsive status epilepticus, NICU-CEEG can help avoid undertreatment and overtreatment. In comatose patients, it can provide useful prognostic information as well as detect potentially treatable causes. Traditional impediments to its application are yielding to technological advances and educational efforts. Real-time digitized EEG in particular has been a major advance. Within limits, somatosensory evoked potential monitoring (ICU-SEP) is useful in the prognosis of coma, but it is less helpful in monitoring focal cerebral ischemia. Brainstem auditory evoked potential monitoring has a relatively restricted role in the NICU but is helpful in distinguishing structural from nonstructural causes of coma and can supplement ICU-SEP in predicting outcome.
Neurointensive care unit system for continuous electrophysiological monitoring with remote web-based review. [2019]There is a need in the neurological intensive care unit for a single integrated bedside monitor for continuously monitoring the function of the patient's central nervous system. In this paper, we demonstrate the feasibility of building such a system and operating it in the intensive care environment. We have developed a fully automated system that samples electrophysiological waveforms of various modalities according to a schedule of predefined intervals along with routinely monitored cardiac and respiratory parameters. The system provides stimulation and acquires responses without requiring supervision. The electrophysiological data include brainstem auditory and somatosensory evoked potentials and epochs of the electroencephalogram. The system applies peak detection and spectral analysis to extract salient parameters from the raw waveforms. The results are made available immediately in real time on the local network for local review and further analysis. A web-based interface makes review by a qualified neurologist possible anywhere within the hospital's secure intranet during and after monitoring. This system could potentially give an early warning of impending herniation, subclinical seizures, and brain or spinal cord ischemia. We demonstrate its application in a few diverse neurological intensive care cases and a case in the interventional neuroradiology suite.
Continuous EEG monitoring in patients with traumatic brain injury reveals a high incidence of epileptiform activity. [2006]EEG is the only available method for real time monitoring of the brain and is therefore of great interest in the neurointensive care. The present study describes our experiences from implying continuous EEG monitoring as a routine method. We also present EEG patterns observed on patients with traumatic brain injury (TBI).
Long-term EEG monitoring in the Neonatal Intensive Care Unit. [2020]Access, in neonatal intensive care units, to neurological monitoring facilities is often limited by the availability of expensive equipment, expert technicians to provide the biomedical support and neurologists, with neonatal experience, to interpret the data. EEG bedside monitoring is now available through the development of low cost portable bedside monitors. This paper discusses the clinical use of one of those monitors: the BRM2, manufactured by Brainz Instruments. A neonatal nurse can apply the electrodes and bedside interpretation is facilitated through an easily operated touch screen. Digital records can also be transferred to a remote expert for further reviewing. The availability of these devices should complement existing monitoring methods and lead to more efficient diagnosis and prognosis of neurological conditions in the neonatal intensive care unit.
Improving safety outcomes in the epilepsy monitoring unit. [2022]Long term video electroencephalography (EEG) in epilepsy monitoring units (EMU) is used to diagnose and treat patients with epilepsy. Injury occurs in the EMU, including reports of death. No standardized patient safety protocols exist. Our objective is to determine the frequency and contributing factors to injury in the EMU. We reviewed medical records and video EEG of patients with epilepsy admitted to our EMU from December 1, 2008 to June 1, 2009. Data was collected on seizure type, onset, length, and frequency. Seizure related falls, injury, and adverse events were recorded. Data regarding the physical environment and treatment during seizures were analyzed too. 20 patients with 170 seizures were collected. Of the 170 total seizures captured, only 1 injury (0.6%) and 6 falls occurred (3.5%). 5 of the 6 falls were related to patients being ambulatory. No seizures resulted in prolonged stay. Of the 170 seizures captured, other adverse events included 1 status epilepticus (0.6%), 2 postictal aggression (1.2%), 4 objects in mouth (2.4%), 14 ambulatory at seizure onset (8.2%) and 5 postictal ambulation from bed (2.9%). Staff responded to 69 out of 170 seizures (40.6%). Of the 101 seizures without staff response, 57 seizures were electrographic without seizure detection software or push button activation. Falls and adverse events that can lead to injury occur in the EMU, yet the degree of actual injury is minimal. To improve safety outcomes, standardized protocols with appropriate outlined nursing care and procedures for continuous monitoring of patients by staff need to be employed.
Conventional (continuous) EEG monitoring in the NICU. [2019]Conventional EEG is being used more frequently in NICUs in the U.S. with the advent of therapeutic hypothermia and the growth of neurocritical care intensivists & units. Historical applications have included assessing encephalopathy, seizure evaluation and prognosis. Past reluctance or limitation of the use in the NICU are receding with the digitization of EEG recordings and increasing interest in the neonatal brain. Continuous EEG monitoring is expanding the potential for its application as a brain monitoring tool to stratify initial injury severity, monitor seizure response to treatment, and detect sentinel neurologic events in the NICU, in addition to guiding neurotherapeutic options. The progression of the EEG background after an acute insult can also increase its prognostic specificity and provide another immediate marker of NICU neurologic outcome. The future of EEG monitoring in the NICU holds many possibilities and may greatly advance the new field of neuroprotection in the NICU.
The Feasibility and Utility of Continuous Sleep Monitoring in Critically Ill Patients Using a Portable Electroencephalography Monitor. [2020]Sleep disruption in critically ill adults can result in acute decrements in cognitive function, including delirium, but it is underdiagnosed in the setting of the intensive care unit (ICU). Although sleep stages can be assessed by polysomnography (PSG), acquisition and interpretation of PSG is costly, is labor intensive, is difficult to do over an extended period of time with critically ill patients (multiple days of continuous recording), and may interfere with patient care. In this pilot study, we investigated the feasibility and utility of monitoring sleep in the ICU setting using a portable electroencephalography (EEG) monitor, the SedLine brain monitor.
Predicting functional outcomes after stroke: an observational study of acute single-channel EEG. [2021]Background: Early and objective prediction of functional outcome after stroke is an important issue in rehabilitation. Electroencephalography (EEG) has long been utilized to describe and monitor brain function following neuro-trauma, and technological advances have improved usability in the acute setting. However, skepticism persists whether EEG can provide the same prognostic value as neurological examination.Objective: The current cohort study examined the relationship between acute single-channel EEG and functional outcomes after stroke.Methods: Resting-state EEG recorded at a single left pre-frontal EEG channel (FP1) was obtained from 16 adults within 72 h of first stroke. At 30 and 90 days, measures of disability (modified Rankin Scale; mRS) and involvement in daily activities (modified Barthel Index; mBI) were obtained. Acute EEG measures were correlated with functional outcomes and compared to an early neurological examination of stroke severity using the National Institute of Health Stroke Scale (NIHSS). Classification of good outcomes (mRS ≤1 or mBI ≥95) was also examined using Receiver Operator Curve analyses.Results: One-third to one-half of participants experienced incomplete post-stroke recovery, depending on the time point and measure. Functional outcomes correlated with acute theta values (rs 0.45-0.60), with the strength of associations equivalent to previously reported values obtained from conventional multi-channel systems. Acute theta values ≥0.25 were associated with good outcomes, with positive (67-83%) and negative predictive values (70-90%) comparable to those obtained using the NIHSS.Conclusions: Acute, single-channel EEG can provide unique, non-overlapping clinical information, which may facilitate objective prediction of functional outcome after stroke.
Evaluation of a new wireless technique for continuous electroencephalography monitoring in neurological intensive care patients. [2021]A novel wireless eight-channel electroencephalography (EEG) headset specially developed for ICUs was tested in regard of comparability with standard 10/20 EEG systems. The continuous EEG (cEEG) derivations via CerebAir EEG headset (Nihon Kohden Europe, Rosbach, Germany) and internationally standardized 10/20 reference EEGs as the diagnostic standard were performed in a mixed collective on a neurointensive care unit (neuro-ICU). The derivations were verified for comparability in detection of EEG background activity, epileptiform discharges, and seizure patterns. Fifty-two patients with vigilance reduction following serious neurological or metabolic diseases were included, and both methods were applied and further analyzed in 47. EEG background activity matched in 24 of 45 patients (53%; p = 0.126), epileptiform discharges matched in 32 (68%) patients (p = 0.162), and seizure activity matched in 98%. Overall, in 89% of the patients, cEEG detected the same or additional ICU-relevant EEG patterns. The tested wireless cEEG headset is a useful monitoring tool in patients with consciousness disorders. The present study indicates that long-term measurements with the wireless eight-channel cEEG lead to a higher seizure and epileptiform discharge detection compared to intermittent 10/20 EEG derivations in the ICU setting.
Integrating Neuromonitoring in Pediatric Emergency Medicine: Exploring Two Options for Point-of-Care Electroencephalogram (pocEEG) via Patient Monitors-A Technical Note. [2023]Central nervous system (CNS) disorders are among the most frequent presentations in critically ill children. Status epilepticus (SE) is a frequent scenario in the resuscitation bay. In patients with altered mental status, non-convulsive SE (NCSE) is often underrecognized and critically impacts the neurological outcome and duration of hospitalization. An electroencephalogram (EEG) is required to diagnose NCSE. However, standard EEG recordings are time- and staff-intensive, and their availability is limited, especially outside regular working hours. We aimed to improve patient care by developing a simplified EEG recording method, using a reduced lead montage (point-of-care EEG-pocEEG), that is suitable for use in pediatric emergency departments. The objective was to devise a cost-effective unit with low space requirements that fitted the existing technical infrastructure. We present two technical options for clinical pocEEG acquisition using patient monitors (GE Carescape, Philips IntelliVue) that enable data collection for educational and research purposes. A simplified, rapid response EEG like the pocEEG enables neuromonitoring of patients with CNS disorders in pediatric emergency settings, facilitating timely diagnosis and treatment initiation when standard EEG is not readily available.