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

June 3, 2008
March 21, 2013
May 2008
April 2011   (final data collection date for primary outcome measure)
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.
mean sedative use [ Time Frame: ICU discharge ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00734409 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
Combining Objective and Subjective Sedation Assessment Tools
Combining Objective and Subjective Sedation Assessment Tools - Second Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Critical Illness
Device: Bispectral Index (BIS) Monitor
BIS monitoring in addition to RASS assessments
Other Names:
  • bispectral Index (BIS) Monitor
  • Richmond agitation sedation scale
  • neurofunction monitor
  • Experimental: RASS plus (BIS)
    Participants in this arm will receive sedation assessment with the RASS scale augmented with Bispectral Index (BIS) Monitor
    Intervention: Device: Bispectral Index (BIS) Monitor
  • No Intervention: RASS only
    Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
July 2011
April 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00734409
PRO00002117, DUHS parent 3930938
No
Duke University
Duke University
Covidien
Principal Investigator: DaiWai M Olson, PhD RN Duke University
Duke University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP