Combining Observational and Physiologic Sedation Assessment Tools (COST)

Duke University

Status and phase: Terminated; Phase 4

Conditions: Brain Injury

Treatments: Other: Ramsay Scale; Device: Bispectral index monitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00538369

Pro00008519

8771-06 - 8RO

Details and patient eligibility

About

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.

Full 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?

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups

standard-of-care

Active Comparator group

Description:

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

Treatment:

Other: Ramsay Scale

standard + BIS

Experimental group

Description:

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.

Treatment:

Device: Bispectral index monitor

Other: Ramsay Scale