Clinical trial NCT00538369: Combining Observational and Physiologic Sedation Assessment Tools
Official title: Combining Observational and Physiologic Sedation Assessment Tools
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Brain Injury
Keywords: Nursing
critical care
sedation assessment
Bispectral index
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: Medtronic - MITG
First posted: 2007-10-02
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

Eligibility criteria: 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

Primary outcomes:
measure: How much sedative was infused
timeFrame: length of stay
Secondary outcomes:
measure: How quickly the subject recovered from sedation
timeFrame: once
measure: The number of undersedation events
timeFrame: length of stay in ICU
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: DaiWai M Olson, PhD RN CCRN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Suzanne M Thoyre, PhD RN
role: STUDY_CHAIR
affiliation: Duke University
name: Carmelo Graffagnino, MD FRCPC
role: STUDY_DIRECTOR
References:
citation: Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.