Combining Observational and Physiologic Sedation Assessment Tools

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-09-30

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.

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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?

Conditions

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Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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standard-of-care

The standard-of-care group will receive sedation assessment and monitoring with the Ramsay scale, which is the accepted tool at this university

Group Type ACTIVE_COMPARATOR

Ramsay Scale

Intervention Type OTHER

While receiving sedation, subjects will be monitored with the Ramsay scale

standard + BIS

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.

Group Type EXPERIMENTAL

Ramsay Scale

Intervention Type OTHER

While receiving sedation, subjects will be monitored with the Ramsay scale

Bispectral index monitor

Intervention Type DEVICE

While receiving sedation, subjects will receive BIS monitoring

Interventions

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Ramsay Scale

While receiving sedation, subjects will be monitored with the Ramsay scale

Intervention Type OTHER

Bispectral index monitor

While receiving sedation, subjects will receive BIS monitoring

Intervention Type DEVICE

Other Intervention Names

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Ramsay sedation scale BIS

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