Combining Objective and Subjective Sedation Assessment Tools (COST_2)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|