Combining Observational and Physiologic Sedation Assessment Tools (COST)
Primary Purpose
Brain Injury
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ramsay Scale
Bispectral index monitor
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injury focused on measuring Nursing, critical care, sedation assessment, Bispectral index
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard-of-care
standard + BIS
Arm Description
The standard-of-care group will receive sedation assessment and monitoring with the Ramsay scale, which is the accepted tool at this university
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.
Outcomes
Primary Outcome Measures
How much sedative was infused
Secondary Outcome Measures
How quickly the subject recovered from sedation
The number of undersedation events
Full Information
NCT ID
NCT00538369
First Posted
October 1, 2007
Last Updated
October 11, 2015
Sponsor
Duke University
Collaborators
University of North Carolina, Medtronic - MITG
1. Study Identification
Unique Protocol Identification Number
NCT00538369
Brief Title
Combining Observational and Physiologic Sedation Assessment Tools
Acronym
COST
Official Title
Combining Observational and Physiologic Sedation Assessment Tools
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Terminated
Why Stopped
Lack of equipoise
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
University of North Carolina, Medtronic - MITG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury
Keywords
Nursing, critical care, sedation assessment, Bispectral index
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard-of-care
Arm Type
Active Comparator
Arm Description
The standard-of-care group will receive sedation assessment and monitoring with the Ramsay scale, which is the accepted tool at this university
Arm Title
standard + BIS
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Ramsay Scale
Other Intervention Name(s)
Ramsay sedation scale
Intervention Description
While receiving sedation, subjects will be monitored with the Ramsay scale
Intervention Type
Device
Intervention Name(s)
Bispectral index monitor
Other Intervention Name(s)
BIS
Intervention Description
While receiving sedation, subjects will receive BIS monitoring
Primary Outcome Measure Information:
Title
How much sedative was infused
Time Frame
length of stay
Secondary Outcome Measure Information:
Title
How quickly the subject recovered from sedation
Time Frame
once
Title
The number of undersedation events
Time Frame
length of stay in ICU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DaiWai M Olson, PhD RN CCRN
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suzanne M Thoyre, PhD RN
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carmelo Graffagnino, MD FRCPC
Organizational Affiliation
Duke University
Official's Role
Study Director
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
4835444
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.
Results Reference
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Combining Observational and Physiologic Sedation Assessment Tools
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