Combining Objective and Subjective Sedation Assessment Tools
COST_2
2 other identifiers
interventional
300
1 country
1
Brief Summary
The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 3, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
September 11, 2012
CompletedMarch 29, 2013
August 1, 2012
2.9 years
June 3, 2008
August 10, 2012
March 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Sedative Use
The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.
Intensive Care Unit (ICU) stay through discharge
Secondary Outcomes (2)
Unplanned Self-device Removal Events
ICU stay through discharge
Mean Days on Mechanical Ventilation
ICU stay- through discharge
Study Arms (2)
RASS plus (BIS)
EXPERIMENTALParticipants in this arm will receive sedation assessment with the RASS scale augmented with Bispectral Index (BIS) Monitor
RASS only
NO INTERVENTIONParticipants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
Interventions
BIS monitoring in addition to RASS assessments
Eligibility Criteria
You may qualify if:
- patient in the ICU
- continuous IV sedation with propofol midazolam or dexmedetomidine
- age \> 18
- expected to require mechanical ventilation for \>=48 hours
You may not qualify if:
- prisoners
- no available space on forehead
- continuous electroencephalography(EEG) monitoring
- bifrontal brain injury
- barbiturate coma therapy
- known hypersensitivity to study medications
- high risk for ethanol (ETOH) withdrawal
- resuscitation from cardiac arrest without recovery of mental status
- moribund clinical state (death expected within 48 hours)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Medtronic - MITGcollaborator
Study Sites (1)
Duke University Health System
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- DaiWai M Olson, PhD RN
- Organization
- Duke University Health System
Study Officials
- PRINCIPAL INVESTIGATOR
DaiWai M Olson, PhD RN
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2008
First Posted
August 14, 2008
Study Start
May 1, 2008
Primary Completion
April 1, 2011
Study Completion
July 1, 2011
Last Updated
March 29, 2013
Results First Posted
September 11, 2012
Record last verified: 2012-08