Neurosteer Bedside Monitoring System

ID#: NCT06718764

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: July 08, 2024

End Date: July 01, 2025

Contact Information:
Leslie Melo, MPH
212-241-3376
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.
Eligibility:

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
Find a Clinical Trial Find Cancer Clinical Trials