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

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00855075
• Other study ID #: 08-03-2038
• Status: Terminated
• Phase: Phase 4
• First received: January 15, 2009
• Last updated: July 27, 2015
• Start date: May 2008
• Est. completion date: February 2010

Study information

• Verified date: July 2015
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Analgesia
• Sedation

Intervention

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.

Locations

Country	Name	City	State
United States	Charleston Area Medical Center Health System	Charleston	West Virginia
United States	Charleston Area Medical Center, General Hospital	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

Hernández-Gancedo C, Pestaña D, Pérez-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. Epub 2007 Aug 16. — View Citation

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. Erratum in: Crit Care Med 2002 Mar;30(3):726. — View Citation

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. — View Citation

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. — View Citation

Sydow M, Neumann P. Sedation for the critically ill. Intensive Care Med. 1999 Jun;25(6):634-6. Review. — View Citation

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. — View Citation

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. Epub 2005 Oct 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of cerebral state index and Richmond Agitation-Sedation Scale		Two years	No