NCT00855075

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

1.6 years

First QC Date

January 15, 2009

Last Update Submit

July 27, 2015

Conditions

SedationAnalgesia

Keywords

SedationAnalgesiaMechanical ventilationCerebral State MonitorCerebral State Index

Outcome Measures

Primary Outcomes (1)

  • Correlation of cerebral state index and Richmond Agitation-Sedation Scale

    Two years

Study Arms (1)

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

Interventions

Cerebral State MonitorDEVICE

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.

Also known as: Danmeter, Cerebral State Index
Cerebral State Monitor

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients admitted with paralysis or a brain injury
  • Patients who are deaf, blind, or have pre-existing dementia/delirium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charleston Area Medical Center, General Hospital

Charleston, West Virginia, 25301, United States

Location

Charleston Area Medical Center Health System

Charleston, West Virginia, 25304, United States

Location

Related Publications (9)

  • 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.

    PMID: 12421743BACKGROUND

  • 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.

    PMID: 12799407BACKGROUND

  • 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.

    PMID: 16809991BACKGROUND

  • 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.

    PMID: 16210310BACKGROUND

  • 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.

    PMID: 16430792BACKGROUND

  • 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.

    PMID: 17701384BACKGROUND

  • 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.

    PMID: 10416920BACKGROUND

  • 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.

    PMID: 11902253BACKGROUND

  • 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.

    PMID: 17122575BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Consciousness Monitors

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Audis Bethea, PharmD, BCPS

    Charleston Area Medical Center Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacy Specialist

Study Record Dates

First Submitted

January 15, 2009

First Posted

March 4, 2009

Study Start

May 1, 2008

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

US(2)