Evaluating the Feasibility of Utilizing a Novel Brain Activity Monitor in the Neurosciences Intensive Care Unit
Icahn School of Medicine at Mount Sinai
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.
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, s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * Histor…
Interventions
- DeviceNeurosteer's single-channel EEG monitoring device
Neurosteer device will be attached to participants forehead and readings will be collected for the duration of their NSICU stay. 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.
Location
- Mount Sinai HospitalNew York, New York