Clinical trial NCT00855075: Correlation of Cerebral State Index With the Richmond Agitation-Sedation Scale in Mechanically Ventilated ICU Patients
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sedation
Analgesia
Keywords: Sedation
Analgesia
Mechanical ventilation
Cerebral State Monitor
Cerebral State Index
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Correlation of cerebral state index and Richmond Agitation-Sedation Scale
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Charleston Area Medical Center, General Hospital
state: West Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center Health System
state: West Virginia
Study officials:
affiliation: Charleston Area Medical Center Health System
name: Audis Bethea, PharmD, BCPS
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1164/rccm.2107138.
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. doi: 10.1001/jama.289.22.2983.
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. doi: 10.1097/00000542-200607000-00009.
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. doi: 10.1093/bja/aei253. Epub 2005 Oct 6.
citation: 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.
citation: 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.
citation: 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.
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. doi: 10.1097/00003246-200201000-00020. No abstract available.
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. doi: 10.1097/00000542-200612000-00012.