Combining Observational and Physiologic Sedation Assessment Tools (COST)

This study has been terminated.
(Lack of equipoise)
Sponsor:
Collaborators:
University of North Carolina
Covidien
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00538369
First received: October 1, 2007
Last updated: June 27, 2013
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Brain Injury
Other: Ramsay Scale
Device: Bispectral index monitor
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Combining Observational and Physiologic Sedation Assessment Tools

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • How much sedative was infused [ Time Frame: length of stay ]

Secondary Outcome Measures:
  • How quickly the subject recovered from sedation [ Time Frame: once ]
  • The number of undersedation events [ Time Frame: length of stay in ICU ]

Enrollment: 67
Study Start Date: November 2006
Study Completion Date: September 2007
Arms Assigned Interventions
Active Comparator: standard-of-care
The standard-of-care group will receive sedation assessment and monitoring with the Ramsay scale, which is the accepted tool at this university
Other: Ramsay Scale
While receiving sedation, subjects will be monitored with the Ramsay scale
Other Name: Ramsay sedation scale
Experimental: standard + BIS
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.
Other: Ramsay Scale
While receiving sedation, subjects will be monitored with the Ramsay scale
Other Name: Ramsay sedation scale
Device: Bispectral index monitor
While receiving sedation, subjects will receive BIS monitoring
Other Name: BIS

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538369

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
University of North Carolina
Covidien
Investigators
Principal Investigator: DaiWai M Olson, PhD RN CCRN Duke University
Study Chair: Suzanne M Thoyre, PhD RN University of North Carolina, Chapel Hill
Study Director: Carmelo Graffagnino, MD FRCPC Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00538369     History of Changes
Other Study ID Numbers: Pro00008519, 8771-06 - 8RO
Study First Received: October 1, 2007
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Nursing
critical care
sedation assessment
Bispectral index

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014