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Combining Objective and Subjective Sedation Assessment Tools (COST_2)

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bispectral Index (BIS) Monitor
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Mechanical ventilation, Human, conscious sedation, bispectral index, monitoring, critical care, propofol

Eligibility Criteria

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

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)

Sites / Locations

  • Duke University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RASS plus (BIS)

RASS only

Arm Description

Participants in this arm will receive sedation assessment with the RASS scale augmented with Bispectral Index (BIS) Monitor

Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution

Outcomes

Primary Outcome Measures

Mean Sedative Use
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
The number of unplanned self-device removal events that took place during the study period.
Mean Days on Mechanical Ventilation
The mean number of days that the patients were on mechanical ventilation.

Full Information

First Posted
June 3, 2008
Last Updated
March 21, 2013
Sponsor
Duke University
Collaborators
Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT00734409
Brief Title
Combining Objective and Subjective Sedation Assessment Tools
Acronym
COST_2
Official Title
Combining Objective and Subjective Sedation Assessment Tools - Second Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Medtronic - MITG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Mechanical ventilation, Human, conscious sedation, bispectral index, monitoring, critical care, propofol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RASS plus (BIS)
Arm Type
Experimental
Arm Description
Participants in this arm will receive sedation assessment with the RASS scale augmented with Bispectral Index (BIS) Monitor
Arm Title
RASS only
Arm Type
No Intervention
Arm Description
Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
Intervention Type
Device
Intervention Name(s)
Bispectral Index (BIS) Monitor
Other Intervention Name(s)
Richmond agitation sedation scale, neurofunction monitor
Intervention Description
BIS monitoring in addition to RASS assessments
Primary Outcome Measure Information:
Title
Mean Sedative Use
Description
The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.
Time Frame
Intensive Care Unit (ICU) stay through discharge
Secondary Outcome Measure Information:
Title
Unplanned Self-device Removal Events
Description
The number of unplanned self-device removal events that took place during the study period.
Time Frame
ICU stay through discharge
Title
Mean Days on Mechanical Ventilation
Description
The mean number of days that the patients were on mechanical ventilation.
Time Frame
ICU stay- through discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DaiWai M Olson, PhD RN
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Combining Objective and Subjective Sedation Assessment Tools

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