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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
BIS monitoring in addition to RASS assessments
Duke University Health System
Durham, North Carolina, United States
Mean Sedative Use
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
Unplanned Self-device Removal Events
The number of unplanned self-device removal events that took place during the study period.
Time frame: ICU stay through discharge
Mean Days on Mechanical Ventilation
The mean number of days that the patients were on mechanical ventilation.
Time frame: ICU stay- through discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.