Correlation of Cerebral State Index With the Richmond Agitation-Sedation Scale in Mechanically Ventilated ICU Patients

Study Overview
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Brief Summary
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The purpose of this study is to correlate the cerebral state index obtained from a cerebral state monitor with the Richmond Agitation-Sedation Scale assessment performed on sedated and mechanically ventilated intensive care patients.

Detailed Description
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Currently there are no objective methods to measure levels of sedation in all ICU patient populations. This generally does not become problematic in most patients. However, certain populations cannot be assessed by standard means. These populations would include patients who are quadriplegic and those who are being treated with neuromuscular blocking agents. The current norm is to use a sedation scale such as the Richmond Agitation-Sedation Scale to assess the patient's level of sedation. An alternative to this would be to use an EEG based method that monitors brain activity. New methods of monitoring brain activity, using cerebral state monitors may provide an effective means of monitoring sedation. The cerebral state monitor, however, and the parameters it provides, the cerebral state index, has not been tested in an ICU setting. Correlating the measurements gained from the cerebral state monitor with the RASS assessment from sedated ICU patients may allow us to develop a method of monitoring sedation in populations that were impossible to monitor previously. Accurately monitoring the level of sedation in these patients may help decrease the incidence of over-sedation and under-sedation.

Official Title
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Correlation of the Cerebral State Index With the Richmond Agitation-Sedation Scale in ICU Patients Who Are Sedated and Mechanically Ventilated: A Pilot Study

Conditions
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Sedation, Analgesia

Intervention / Treatment
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* Device: Cerebral State Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission the surgical-trauma intensive care unit at the Charleston Area Medical Center General Hospital Adult (18-85 years of age) Anticipated duration of mechanical ventilation of at least 72 hours Exclusion Criteria: Patients admitted with paralysis or a brain injury Patients who are deaf, blind, or have pre-existing dementia/delirium

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Cerebral State Monitor<br>A cerebral state monitor will provide a cerebral state index for mechanically ventilated intensive care patients. Recorded cerebral state indexes will be correlated with clinical assessments of sedation using the Richmond Agitation-Sedation Scale. | Device: Cerebral State Monitor<br>* A cerebral state monitor will provide a cerebral state index for mechanically ventilated intensive care patients. Recorded cerebral state indexes will be correlated with clinical assessments of sedation using the Richmond Agitation-Sedation Scale.<br>* Other names: Cerebral State Index;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of cerebral state index and Richmond Agitation-Sedation Scale |  | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, Analgesia, Mechanical ventilation, Cerebral State Monitor, Cerebral State Index