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Combining Objective and Subjective Sedation Assessment Tools (COST_2)

This study has been completed.
Medtronic - MITG
Information provided by (Responsible Party):
Duke University Identifier:
First received: June 3, 2008
Last updated: March 21, 2013
Last verified: August 2012
The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation.

Condition Intervention
Critical Illness Device: Bispectral Index (BIS) Monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combining Objective and Subjective Sedation Assessment Tools - Second Study

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Mean Sedative Use [ Time Frame: Intensive Care Unit (ICU) stay through discharge ]
    The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.

Secondary Outcome Measures:
  • Unplanned Self-device Removal Events [ Time Frame: ICU stay through discharge ]
    The number of unplanned self-device removal events that took place during the study period.

  • Mean Days on Mechanical Ventilation [ Time Frame: ICU stay- through discharge ]
    The mean number of days that the patients were on mechanical ventilation.

Enrollment: 300
Study Start Date: May 2008
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RASS plus (BIS)
Participants in this arm will receive sedation assessment with the RASS scale augmented with Bispectral Index (BIS) Monitor
Device: Bispectral Index (BIS) Monitor
BIS monitoring in addition to RASS assessments
Other Names:
  • Richmond agitation sedation scale
  • neurofunction monitor
No Intervention: RASS only
Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution

Detailed Description:

Patients in the intensive care unit (ICU) who require a ventilator to help them breathe also require sedation in order to keep them comfortable and prevent injury. The national guidelines for sedation management include a daily interruption of sedation performed once each morning. To determine the amount of sedation needed, the current standard practice is to use a system called the Richmond Agitation-Sedation Scale (RASS). The patient is stimulated by calling their name or by tapping their shoulder until the patient's responses indicate that a satisfactory level of sedation has been achieved.

The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the RASS will give better assessment of a subject's level of sedation. The BIS monitor is a sensor strip taped to the forehead and attached to a device that reads electrical activity from the brain. It is approved by the U.S. Food and Drug Administration (FDA) for monitoring patients under sedation.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patient in the ICU
  • continuous IV sedation with propofol midazolam or dexmedetomidine
  • age > 18
  • expected to require mechanical ventilation for >=48 hours

Exclusion Criteria:

  • prisoners
  • no available space on forehead
  • continuous electroencephalography(EEG) monitoring
  • bifrontal brain injury
  • barbiturate coma therapy
  • known hypersensitivity to study medications
  • high risk for ethanol (ETOH) withdrawal
  • resuscitation from cardiac arrest without recovery of mental status
  • moribund clinical state (death expected within 48 hours)
  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 identifier: NCT00734409

United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Medtronic - MITG
Principal Investigator: DaiWai M Olson, PhD RN Duke University
  More Information

Responsible Party: Duke University Identifier: NCT00734409     History of Changes
Other Study ID Numbers: PRO00002117
DUHS parent 3930938 ( Other Grant/Funding Number: Covidien )
Study First Received: June 3, 2008
Results First Received: August 10, 2012
Last Updated: March 21, 2013

Keywords provided by Duke University:
Mechanical ventilation
conscious sedation
bispectral index
critical care

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes processed this record on September 19, 2017