Combining Objective and Subjective Sedation Assessment Tools (COST_2)
|ClinicalTrials.gov Identifier: NCT00734409|
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : September 11, 2012
Last Update Posted : March 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Device: Bispectral Index (BIS) Monitor||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combining Objective and Subjective Sedation Assessment Tools - Second Study|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||July 2011|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734409
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||DaiWai M Olson, PhD RN||Duke University|