Combining Objective and Subjective Sedation Assessment Tools (COST_2)
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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 |
- 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.
| 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:
|
|
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 |
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| United States, North Carolina | |
| Duke University Health System | |
| Durham, North Carolina, United States, 27710 | |
| 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 June 13, 2013