Combining Objective and Subjective Sedation Assessment Tools (COST_2)

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00734409
First received: June 3, 2008
Last updated: March 21, 2013
Last verified: August 2012
  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
Critical Illness
Device: Bispectral Index (BIS) Monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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: Intensive Care Unit (ICU) stay through discharge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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:
  • bispectral Index (BIS) Monitor
  • 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.

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734409

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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734409     History of Changes
Other Study ID Numbers: PRO00002117, DUHS parent 3930938
Study First Received: June 3, 2008
Results First Received: August 10, 2012
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014