Clinical trial NCT06718764: Neurosteer Bedside Monitoring System
Official title: Evaluating the Feasibility of Utilizing a Novel Brain Activity Monitor in the Neurosciences Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium
Sedation
Agitation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Neurosteer Ltd.
First posted: 2024-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: In the study population of sedated, intubated critically ill patients, the research team hypothesize the following:

* Neurosteer's derived signals and parameters will be correlated to and will have at least fair agreement with the Richmond Agitation Sedation Scale (RASS) for measuring depth of sedation.
* Neurosteer's derived signals and parameters will be correlated to and have at least fair agreement with the Confusion Assessment Method (CAM-ICU) to screen for and diagnose delirium.
* For enrolled patients undergoing cEEG monitoring as standard of care, the detection of burst suppression, seizures, and ictal-interictal continuum between Neurosteer's derived signals and parameters and continuous EEG monitoring readings will be correlated and have at least fair agreement.
* There will be no significant difference in the correlations determined in our primary objective between NSICU patients with and without ANI.

The research team will be conducting a single-site study to evaluate these hypotheses. The research team will enroll 100 patients admitted to the NSICU. 50 of these patients will have an ANI and the other 50 will not have an ANI. The research team will define ANI as subjects 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. The research team will define subject 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. The research team will obtain written informed consent from all patients and/or their Legally Authorized Representative (LAR) to conduct the study. All enrolled patients will receive the intervention, the Neurosteer brain monitoring platform. Intra-individual comparisons will be made between standard of care assessments and the findings of the Neurosteer device. Inter-individual comparisons between patients with and without ANI will also be made. Statistical analyses will be conducted halfway through study enrollment and upon completion of enrollment and data entry. The study intervention will span the duration of the patient's admission in the NSICU. Patients will be screened for consented and screened for eligibility as they get admitted to the NSICU.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form from patient and/or LAR, including stated willingness to comply with all study procedures and availability for the duration of the study
* Any assigned sex at birth, including individuals who are transgender or intersex
* Age 18 years or older
* Mechanically ventilated patients with an anticipated LOS \>/=48 hours on any sedative drips including propofol, midazolam, dexmedetomidine, fentanyl, dialudid, ketamine

Exclusion Criteria:

* Has known hearing problems and usage of hearing aids
* Has a rash on forehead
* History of polysubstance abuse
* Severe dementia
* Anticipated Withdrawing Life-Sustaining Therapy (WLST) within the next 24-48 hours

Primary outcomes:
measure: Sedation as measured by Richmond Agitation Sedation Scale
timeFrame: 3-4 times daily throughout participants NSICU stay (average 14 days)
Secondary outcomes:
measure: Delirium as measured by Confusion Assessment Method (CAM)
timeFrame: 1-2 times daily throughout participants NSICU stay (average 14 days)
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21
role: PRINCIPAL_INVESTIGATOR
References: