Combining Objective and Subjective Sedation Assessment Tools - Second Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- Duke University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Mean Sedative Use
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Mean Sedative Use
Time Frame: Intensive Care Unit (ICU) stay through discharge
The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.
Secondary Outcomes
- Unplanned Self-device Removal Events(ICU stay through discharge)
- Mean Days on Mechanical Ventilation(ICU stay- through discharge)