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Behavioural Intervention

Brain Monitoring Device for ICU Patients

N/A

Recruiting

Led By Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Mechanically ventilated patients with an anticipated length of stay greater than or equal to 48 hours on any sedative drips including propofol, midazolam, dexmedetomidine, fentanyl, dialudid, ketamine

Must not have

Severe dementia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-4 times daily throughout participants nsicu stay (average 14 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if Neurosteer's brain monitoring device can effectively monitor delirium, sedation, and agitation in ICU patients who are intubated and sedated. The study will

Who is the study for?

This trial is for ICU patients, both with and without acute neurological injuries (ANI), who are intubated and sedated. It aims to include a total of 100 participants, split evenly between those with ANI and those without.

What is being tested?

The study tests Neurosteer's EEG device designed to monitor brain activity related to delirium, sedation, and agitation. All patients will use the device which will be compared against standard monitoring scales like RASS & CAM-ICU.

What are the potential side effects?

Since this trial involves non-invasive EEG monitoring through a forehead-attached device and auditory stimulation via earphones, side effects are expected to be minimal if any.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am on a ventilator and expected to stay in the hospital for at least 2 days on sedatives.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe memory loss that affects my daily life.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-4 times daily throughout participants nsicu stay (average 14 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-4 times daily throughout participants nsicu stay (average 14 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-4 times daily throughout participants nsicu stay (average 14 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sedation as measured by Richmond Agitation Sedation Scale

Secondary study objectives

Delirium as measured by Confusion Assessment Method (CAM)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: NSICU Patients with Acute Neurological Injuries (ANI)Active Control1 Intervention

ANI are participants 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. All participants will be set up with the Neurosteer bedside monitoring system.

Group II: NSICU Patients without Acute Neurological Injuries (ANI)Active Control1 Intervention

Participants 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. All participants will be set up with the Neurosteer bedside monitoring system.

0 / 3Eligibility criteria met