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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
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injury focused on measuring Nursing, critical care, sedation assessment, Bispectral index

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
October 1, 2007
Last Updated
October 11, 2015
Sponsor
Duke University
Collaborators
University of North Carolina, Medtronic - MITG
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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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