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

This study has been terminated.
(Technology used to obtain/measure cerebral state index is no longer manufactured)
Sponsor:
Information provided by:
CAMC Health System
ClinicalTrials.gov Identifier:
NCT00855075
First received: January 15, 2009
Last updated: December 23, 2010
Last verified: December 2010
  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

Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • 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:
  • Danmeter
  • Cerebral State Index

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
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855075

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
Sponsors and Collaborators
CAMC Health System
Investigators
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 September 16, 2014