Correlation of Cerebral State Index With the Richmond Agitation-Sedation Scale in Mechanically Ventilated ICU Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sedation Analgesia |
Device: Cerebral State Monitor |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Correlation of the Cerebral State Index With the Richmond Agitation-Sedation Scale in ICU Patients Who Are Sedated and Mechanically Ventilated: A Pilot Study |
- Correlation of cerebral state index and Richmond Agitation-Sedation Scale [ Time Frame: Two years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Cerebral State Monitor
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
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.
Other Names:
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Critically ill adults admitted to the surgical-trauma unit at Charleston Area Medical Center with an anticipated duration of mechanical ventilation of at least 72 hours.
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
Contacts and Locations| United States, West Virginia | |
| Charleston Area Medical Center, General Hospital | |
| Charleston, West Virginia, United States, 25301 | |
| Charleston Area Medical Center Health System | |
| Charleston, West Virginia, United States, 25304 | |
| Principal Investigator: | Audis Bethea, PharmD, BCPS | Charleston Area Medical Center Health System |
More Information
Publications:
| Responsible Party: | Audis Bethea, PharmD, BCPS, Charleston Area Medical Center Health System |
| ClinicalTrials.gov Identifier: | NCT00855075 History of Changes |
| Other Study ID Numbers: | 08-03-2038 |
| Study First Received: | January 15, 2009 |
| Last Updated: | December 23, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by CAMC Health System:
|
Sedation Analgesia Mechanical ventilation Cerebral State Monitor Cerebral State Index |
ClinicalTrials.gov processed this record on June 17, 2013