Combining Objective and Subjective Sedation Assessment Tools (COST_2)

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00734409
First received: June 3, 2008
Last updated: March 21, 2013
Last verified: August 2012
  Purpose

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.


Condition Intervention
Critical Illness
Device: Bispectral Index (BIS) Monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combining Objective and Subjective Sedation Assessment Tools - Second Study

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Mean Sedative Use [ Time Frame: Intensive Care Unit (ICU) stay through discharge ] [ Designated as safety issue: No ]
    The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.


Secondary Outcome Measures:
  • Unplanned Self-device Removal Events [ Time Frame: ICU stay through discharge ] [ Designated as safety issue: Yes ]
    The number of unplanned self-device removal events that took place during the study period.

  • Mean Days on Mechanical Ventilation [ Time Frame: ICU stay- through discharge ] [ Designated as safety issue: No ]
    The mean number of days that the patients were on mechanical ventilation.


Enrollment: 300
Study Start Date: May 2008
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RASS plus (BIS)
Participants in this arm will receive sedation assessment with the RASS scale augmented with Bispectral Index (BIS) Monitor
Device: Bispectral Index (BIS) Monitor
BIS monitoring in addition to RASS assessments
Other Names:
  • bispectral Index (BIS) Monitor
  • Richmond agitation sedation scale
  • neurofunction monitor
No Intervention: RASS only
Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution

Detailed Description:

Patients in the intensive care unit (ICU) who require a ventilator to help them breathe also require sedation in order to keep them comfortable and prevent injury. The national guidelines for sedation management include a daily interruption of sedation performed once each morning. To determine the amount of sedation needed, the current standard practice is to use a system called the Richmond Agitation-Sedation Scale (RASS). The patient is stimulated by calling their name or by tapping their shoulder until the patient's responses indicate that a satisfactory level of sedation has been achieved.

The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the RASS will give better assessment of a subject's level of sedation. The BIS monitor is a sensor strip taped to the forehead and attached to a device that reads electrical activity from the brain. It is approved by the U.S. Food and Drug Administration (FDA) for monitoring patients under sedation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient in the ICU
  • continuous IV sedation with propofol midazolam or dexmedetomidine
  • age > 18
  • expected to require mechanical ventilation for >=48 hours

Exclusion Criteria:

  • 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)
  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: NCT00734409

Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Covidien
Investigators
Principal Investigator: DaiWai M Olson, PhD RN Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734409     History of Changes
Other Study ID Numbers: PRO00002117, DUHS parent 3930938
Study First Received: June 3, 2008
Results First Received: August 10, 2012
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Mechanical ventilation
Human
conscious sedation
bispectral index
monitoring
critical care
propofol

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014