Mount Sinai Hospital
New York, 10029, United States
Location status: Recruiting
Location contact
Leslie Melo, MPH
CONTACT
Neha S Dangayach
PRINCIPAL_INVESTIGATOR
Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21
CONTACT
NCT Number: NCT06718764
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10029, United States
Location status: Recruiting
Leslie Melo, MPH
CONTACT
Neha S Dangayach
PRINCIPAL_INVESTIGATOR
Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21
CONTACT
In the study population of sedated, intubated critically ill patients, the research team hypothesize the following:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3-4 times daily throughout participants NSICU stay (average 14 days)
Richmond Agitation Sedation Scale (RASS) for measuring the depth of sedation in sedated, intubated critically ill patients. RASS scoring -5 to +4, is a valid and reliable instrument to assess level of sedation and agitated behavior during sedation, where higher scores indicate higher levels of agitation.
4 Combative, violent, danger to staff 3 Pulls or removes tube(s) or catheters; aggressive 2 Frequent non-purposeful movement
1 Anxious, apprehensive, but not aggressive 0 Alert and calm
Time frame: 1-2 times daily throughout participants NSICU stay (average 14 days)
Confusion Assessment Method (CAM) for screening and diagnosing delirium in intubated, sedated critically ill patients. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
Contact information is provided by the study sponsor or research team.
Icahn School of Medicine at Mount Sinai
Other
Evaluating the Feasibility of Utilizing a Novel Brain Activity Monitor in the Neurosciences Intensive Care Unit
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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