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| ID | Type | Description | Link |
|---|---|---|---|
| 8771-06 - 8RO |
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Lack of equipoise
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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
| Medtronic - MITG | INDUSTRY |
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When a physiologic tool to measure the patient's hypnotic state is added to current practice tools is there a decrease in the amount of drug the patient receives.
The purposes of this study were to examine the effect of combining a physiologic measure of consciousness (BIS) with observational assessment of sedation (Ramsay) on infused sedation drug volumes, undersedation events, and the recovery time to arouse from sedation, in a group of neurocritically ill patients. During a 12-hour data collection period, patients received sedation assessment and management with either the current standard of care (sedation assessment with the Ramsay scale), or the standard of care plus the addition of physiologic data from BIS monitoring. Planned research questions explored how BIS monitoring impacts short-term sedation-related outcomes.
Research Questions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard-of-care | Active Comparator | The standard-of-care group will receive sedation assessment and monitoring with the Ramsay scale, which is the accepted tool at this university |
|
| standard + BIS | Experimental | Subjects in the standard-of-care + BIS group will receive sedation assessment and monitoring using the Ramsay scale and values from the bispectral index (BIS) monitor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramsay Scale | Other | While receiving sedation, subjects will be monitored with the Ramsay scale |
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| Measure | Description | Time Frame |
|---|---|---|
| How much sedative was infused | length of stay |
| Measure | Description | Time Frame |
|---|---|---|
| How quickly the subject recovered from sedation | once | |
| The number of undersedation events | length of stay in ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DaiWai M Olson, PhD RN CCRN | Duke University | Principal Investigator |
| Suzanne M Thoyre, PhD RN | University of North Carolina, Chapel Hill | Study Chair |
| Carmelo Graffagnino, MD FRCPC | Duke University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4835444 | Background | Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656. |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D056805 | Consciousness Monitors |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Bispectral index monitor | Device | While receiving sedation, subjects will receive BIS monitoring |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |