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

Terminated

• Conditions: Analgesia; Sedation

• Registration Number: NCT00855075
• Lead Sponsor: CAMC Health System

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-03-03
• Study First Posted: 2009-03-04
• Primary Completion: 2009-12
• Study Completion: 2010-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of cerebral state index and Richmond Agitation-Sedation Scale	Two years

Trial Locations

Locations (2)

Charleston Area Medical Center, General Hospital; 🇺🇸 Charleston, West Virginia, United States

Charleston Area Medical Center Health System; 🇺🇸 Charleston, West Virginia, United States