Duke University Health System
Durham, North Carolina, 27710, United States
NCT Number: NCT00734409
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BIS monitoring in addition to RASS assessments
Other names: Richmond agitation sedation scale, neurofunction monitor
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.
Time frame: ICU stay through discharge
The number of unplanned self-device removal events that took place during the study period.
Time frame: ICU stay- through discharge
The mean number of days that the patients were on mechanical ventilation.
Duke University
Other
Combining Objective and Subjective Sedation Assessment Tools - Second Study
Acronym: COST_2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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