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Sponsors and Collaborators: |
Duke University Aspect Medical Systems |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00734409 |
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 |
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Sedation |
Device: Bispectral Index Monitor |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Combining Objective and Subjective Sedation Assessment Tools - Second Study |
Estimated Enrollment: | 350 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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RASS plus BIS: Experimental
Participants in this arm will receive sedation assessement with the RASS scale augmented with BIS monitoring.
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Device: Bispectral Index Monitor
BIS monitoring in addition to RASS assessments
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RASS only: No Intervention
Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: DaiWai M Olson, PhD RN | 919/668-3751 | Olson006@mc.duke.edu |
Contact: Coretta L Miller | 919/668-3751 | Coretta.miller@duke.edu |
United States, North Carolina | |
Duke University Health System | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: DaiWai M Olson, PhD RN 919-668-3751 Olson006@mc.duke.edu | |
Contact: Coretta L Miller 919/668-3751 coretta.miller@duke.edu |
Principal Investigator: | DaiWai M Olson, PhD RN | Duke University |
Responsible Party: | Duke University Hospital ( DaiWai Olson ) |
Study ID Numbers: | PRO00002117, DUHS parent 3930938 |
Study First Received: | June 3, 2008 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00734409 History of Changes |
Health Authority: | United States: Institutional Review Board |
Mechanical ventilation Human conscious sedation bispectral index |
monitoring critical care propofol |
Propofol |