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Combining Objective and Subjective Sedation Assessment Tools (COST_2)
This study is currently recruiting participants.
Verified by Duke University, August 2008
First Received: June 3, 2008   Last Updated: August 13, 2008   History of Changes
Sponsors and Collaborators: Duke University
Aspect Medical Systems
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00734409
  Purpose

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
Sedation
Device: Bispectral Index Monitor

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: Combining Objective and Subjective Sedation Assessment Tools - Second Study

Further study details as provided by Duke University:

Primary Outcome Measures:
  • mean sedative use [ Time Frame: ICU discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of unplanned self-device removal events [ Time Frame: ICU discharge ] [ Designated as safety issue: Yes ]
  • mean time to wake up after sedation is turned off [ Time Frame: first day of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: May 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
RASS plus BIS: Experimental
Participants in this arm will receive sedation assessement with the RASS scale augmented with BIS monitoring.
Device: Bispectral Index Monitor
BIS monitoring in addition to RASS assessments
RASS only: No Intervention
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 EEG monitoring
  • bifrontal brain injury
  • barbiturate coma therapy
  • known hypersensitivity to study medications
  • high risk for ETOH withdrawal
  • resuscitation from cardiac arrest without recovery of mental status
  • moribund clinical state (death expected within 48 hours)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734409

Contacts
Contact: DaiWai M Olson, PhD RN 919/668-3751 Olson006@mc.duke.edu
Contact: Coretta L Miller 919/668-3751 Coretta.miller@duke.edu

Locations
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: DaiWai M Olson, PhD RN     919-668-3751     Olson006@mc.duke.edu    
Contact: Coretta L Miller     919/668-3751     coretta.miller@duke.edu    
Sponsors and Collaborators
Duke University
Aspect Medical Systems
Investigators
Principal Investigator: DaiWai M Olson, PhD RN Duke University
  More Information

No publications provided

Responsible Party: Duke University Hospital ( DaiWai Olson )
Study ID Numbers: PRO00002117, DUHS parent 3930938
Study First Received: June 3, 2008
Last Updated: August 13, 2008
ClinicalTrials.gov Identifier: NCT00734409     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Propofol

ClinicalTrials.gov processed this record on September 04, 2009