NCT00538369

Combining Observational and Physiologic Sedation Assessment Tools

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 * Is there less sedation drug use for patients when nurses monitor sedation with BIS augmentation of Ramsay than when nurses monitor patients with Ramsay alone? * Is sedation assessment augmented by BIS use associated with a decreased time to wake-up (recovery time) when nurses are instructed to interrupt sedation and obtain a neurologic examination, compared to use of Ramsay alone? * Are there differences in the number of events associated with undersedation (e.g., self-extubation) for patients assigned to BIS augmentation compared to patients assigned to Ramsay alone?

Conditions

• Brain Injury

Interventions

Type	Name	Description
OTHER	Ramsay Scale	While receiving sedation, subjects will be monitored with the Ramsay scale
DEVICE	Bispectral index monitor	While receiving sedation, subjects will receive BIS monitoring

Timeline

• Start date: 2006-11-01
• Completion: 2007-09-01
• First posted: 2007-10-02
• Last updated: 2015-10-14

Locations

1 site across 1 country: United States