Sedation Monitoring Using Frontal Electroencephalogram, Electromyogram and Hemodynamic Responses to Pain in Critical Care

Study Overview
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Brief Summary
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Purpose: Assessing nociception and sedation in mechanically ventilated patients in the ICU is challenging, with few reliable methods available for continuous monitoring. Measurable cardiovascular and neurophysiological variables, such as blood pressure, heart rate, frontal EEG, and frontal EMG, might provide a medium for sedation and nociception monitoring. The hypothesis of this explorative study is that the aforementioned variables correlate with the level of sedation, as described by the Richmond Agitation-Sedation score (RASS). Methods: Thirty adult postoperative ICU patients on mechanical ventilation and receiving intravenous sedation, excluding patients with primary neurological disorders, head injury, or need for continuous neuromuscular blockage. Continuous measurements of bispectral index (BIS), EMG power (EMG), EMG-derived Responsiveness Index (RI), averaged blood pressure variability (ARV), and Surgical Pleth Index (SPI) were tested against repeated RASS measurements, and separately against responsiveness to painful stimuli at varying RASS levels.

Official Title
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Sedation Monitoring Using Frontal Electroencephalogram, Electromyogram and Hemodynamic Responses to Pain in Critical Care

Conditions
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Electroencephalography, Critical Care, Electromyography

Intervention / Treatment
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* Diagnostic Test: Continuous EEG and EMG monitoring, with derived variables


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (over 18 years old) Postoperative ICU admission (planned and un-planned admissions), on mechanical ventilation via an endotracheal tube, with invasive hemodynamic monitoring via an arterial line receiving intravenous sedation by continuous infusion (propofol, midazolam). Exclusion Criteria: primary neurological disorders (including stroke, cardiac arrest with probable hypoxic brain injury, intracranial hemorrhage, and head injury with reduced level of consciousness prior to intubation), the continuous use of neuromuscular blocking agents during monitoring, confirmed meningitis or encephalitis, or a short data collection time (less than 12 hours).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critical Care Patients<br>Critical care patients requiring mechanical ventilation via an endotracheal tube, with invasive hemodynamic monitoring via an arterial line, and receiving intravenous sedation by continuous infusion (propofol, midazolam). | Diagnostic Test: Continuous EEG and EMG monitoring, with derived variables<br>* All patients are monitored during their ICU stay by frontal EEG and EMG measuring devides, which are already in clinical use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG and EMG variables correlate with the level of sedation (as measured by the established RASS score), and are reactive with nociceptive stimulation. | Noninvasive neuromonitoring variables are collected and analysed against the RASS score, which quantifies patient's sedation level. | 2 (1-3) days from admission to ICU |