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

NCT ID: NCT00855075

Last Updated: 2015-07-29

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-02-28

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.

Conditions

Sedation; Analgesia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cerebral State Monitor

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Other Intervention Names

Danmeter; Cerebral State Index

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CAMC Health System

OTHER

Sponsor Role: lead

Responsible Party

Audis Bethea, Pharm.D.

Clinical Pharmacy Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Audis Bethea, PharmD, BCPS

Role: PRINCIPAL_INVESTIGATOR

Charleston Area Medical Center Health System

Locations

Charleston Area Medical Center, General Hospital

Charleston, West Virginia, United States

Charleston Area Medical Center Health System

Charleston, West Virginia, United States

Countries

United States

References

Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. doi: 10.1097/00003246-200201000-00020. No abstract available.

Reference Type: BACKGROUND

PMID: 11902253 (View on PubMed)

Vereecke HE, Vanluchene AL, Mortier EP, Everaert K, Struys MM. The effects of ketamine and rocuronium on the A-Line auditory evoked potential index, Bispectral Index, and spectral entropy monitor during steady state propofol and remifentanil anesthesia. Anesthesiology. 2006 Dec;105(6):1122-34. doi: 10.1097/00000542-200612000-00012.

Reference Type: BACKGROUND

PMID: 17122575 (View on PubMed)

Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.

Reference Type: BACKGROUND

PMID: 12421743 (View on PubMed)

Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.

Reference Type: BACKGROUND

PMID: 12799407 (View on PubMed)

Jensen EW, Litvan H, Revuelta M, Rodriguez BE, Caminal P, Martinez P, Vereecke H, Struys MM. Cerebral state index during propofol anesthesia: a comparison with the bispectral index and the A-line ARX index. Anesthesiology. 2006 Jul;105(1):28-36. doi: 10.1097/00000542-200607000-00009.

Reference Type: BACKGROUND

PMID: 16809991 (View on PubMed)

Zhong T, Guo QL, Pang YD, Peng LF, Li CL. Comparative evaluation of the cerebral state index and the bispectral index during target-controlled infusion of propofol. Br J Anaesth. 2005 Dec;95(6):798-802. doi: 10.1093/bja/aei253. Epub 2005 Oct 6.

Reference Type: BACKGROUND

PMID: 16210310 (View on PubMed)

Anderson RE, Jakobsson JG. Cerebral state monitor, a new small handheld EEG monitor for determining depth of anaesthesia: a clinical comparison with the bispectral index during day-surgery. Eur J Anaesthesiol. 2006 Mar;23(3):208-12. doi: 10.1017/S0265021505002206.

Reference Type: BACKGROUND

PMID: 16430792 (View on PubMed)

Hernandez-Gancedo C, Pestana D, Perez-Chrzanowska H, Martinez-Casanova E, Criado A. Comparing Entropy and the Bispectral index with the Ramsay score in sedated ICU patients. J Clin Monit Comput. 2007 Oct;21(5):295-302. doi: 10.1007/s10877-007-9087-7. Epub 2007 Aug 16.

Reference Type: BACKGROUND

PMID: 17701384 (View on PubMed)

Sydow M, Neumann P. Sedation for the critically ill. Intensive Care Med. 1999 Jun;25(6):634-6. doi: 10.1007/s001340050917. No abstract available.

Reference Type: BACKGROUND

PMID: 10416920 (View on PubMed)

Other Identifiers

08-03-2038

Identifier Type: -

Identifier Source: org_study_id