Combining Observational and Physiologic Sedation Assessment Tools

Study Overview
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Brief Summary
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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.

Detailed Description
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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?

Official Title
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Combining Observational and Physiologic Sedation Assessment Tools

Conditions
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Brain Injury

Intervention / Treatment
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* Other: Ramsay Scale
* Device: Bispectral index monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult admitted with a neurological or neurosurgical diagnosis intubated and on mechanical ventilatory support receiving continuous sedation with propofol Glasgow Coma Score <12 Exclusion Criteria: bifrontal brain injury status epilepticus barbiturate coma therapy continuous benzodiazepine administration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard-of-care<br>The standard-of-care group will receive sedation assessment and monitoring with the Ramsay scale, which is the accepted tool at this university | Other: Ramsay Scale<br>* While receiving sedation, subjects will be monitored with the Ramsay scale<br>* Other names: Ramsay sedation scale;|
| Experimental: standard + BIS<br>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. | Other: Ramsay Scale<br>* While receiving sedation, subjects will be monitored with the Ramsay scale<br>* Other names: Ramsay sedation scale;Device: Bispectral index monitor<br>* While receiving sedation, subjects will receive BIS monitoring<br>* Other names: BIS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How much sedative was infused |  | length of stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How quickly the subject recovered from sedation |  | once | 
| The number of undersedation events |  | length of stay in ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nursing, critical care, sedation assessment, Bispectral index