Neurosteer Bedside Monitoring System

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Has known hearing problems and usage of hearing aids

Has a rash on forehead

History of polysubstance abuse

Severe dementia

Trial design

Treatments tested in this trial

  • Neurosteer's single-channel EEG monitoring device

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators