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

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ClinicalTrials.gov Identifier: NCT00855075
Recruitment Status : Terminated (Technology used to obtain/measure cerebral state index is no longer manufactured)
First Posted : March 4, 2009
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Sedation Analgesia Device: Cerebral State Monitor Phase 4

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.

Study Design

Study Type : Observational
Actual Enrollment : 3 participants
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
Study Start Date : May 2008
Primary Completion Date : December 2009
Study Completion Date : February 2010
Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Correlation of cerebral state index and Richmond Agitation-Sedation Scale [ Time Frame: Two years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Pharm.D., Clinical Pharmacy Specialist, CAMC Health System
ClinicalTrials.gov Identifier: NCT00855075     History of Changes
Other Study ID Numbers: 08-03-2038
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by Audis Bethea, Pharm.D., CAMC Health System:
Sedation
Analgesia
Mechanical ventilation
Cerebral State Monitor
Cerebral State Index