Combining Objective and Subjective Sedation Assessment Tools (COST_2)
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.
|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|
- 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.
- 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.
|Study Start Date:||May 2008|
|Study Completion Date:||July 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
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
No Intervention: RASS only
Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734409
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||DaiWai M Olson, PhD RN||Duke University|