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Combining Observational and Physiologic Sedation Assessment Tools

Combining Observational and Physiologic Sedation Assessment Tools

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00538369
Acronym
COST
Enrollment
67
Registered
2007-10-02
Start date
2006-11-30
Completion date
2007-09-30
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury

Keywords

Nursing, critical care, sedation assessment, Bispectral index

Brief 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?

Interventions

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

While receiving sedation, subjects will receive BIS monitoring

Sponsors

University of North Carolina
CollaboratorOTHER
Medtronic - MITG
CollaboratorINDUSTRY
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
How much sedative was infusedlength of stay

Secondary

MeasureTime frame
How quickly the subject recovered from sedationonce
The number of undersedation eventslength of stay in ICU

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026