Patients Who Are Mechanically Ventilated and Sedated Clinical Trial
Official title:
BIS-Guided Sedation Monitoring: A Prospective Randomized Study
This study looks to assess whether monitoring sedation status in mechanically-ventilated
Medical Surgical Intensive Care Unit (MSICU) patients using Bispectral index (BIS)
monitor-augmented sedation monitoring as opposed to Richmond Agitation Sedation Scale (RASS)
score is associated with decreased duration of mechanical ventilation.
Investigators hypothesize that using BIS monitors to help monitor depth of sedation in
mechanically ventilated ICU patient will result in a decreased duration of mechanical
ventilation when compared to solely utilizing clinical sedation scales such as RASS.
Participants will be randomized into two groups, the intervention group will receive
sedation monitoring with BIS monitoring plus RASS. The control group will receive sedation
monitoring with RASS score only. Randomization will be accomplished through online
randomization software.
For randomization purposes, the intervention group will be labeled as the "A" group. The
control group will labeled as the "B" group. In the BIS-augmented group, sedation
requirement will be titrated according to an average of BIS reading in the 5 minute period
prior to assessment with a goal of maintaining a value of (60-70) in addition to a RASS
score goal of (-1 to -2), provided no noxious stimulation such as endotracheal suctioning
and/or wound dressing has occurred for at least 30 minutes, BIS values have been stable for
at least 5 minutes, signal quality index (>80%), minimal EMG interference (<50%), patient is
not shivering, and patient does not have warmer or other devices that may produce an
electric current on their body or nearby. In the RASS group, sedation requirements will be
titrated to maintain a RASS score of (-1 to -2), will be assessed via the nurse taking care
of the patient provided no noxious stimulation has occurred for at least 30 minutes prior to
assessment.
Both groups will have sedation assessment at least every 6 hours during a 12 hour shift and
as needed as per ICU RN and/or physician. Nurses will be free to exercise their judgment if
they deem that their patients require more or less sedation that is inconsistent with
patient's BIS or RASS score, they will, however, be required to provide a rationale for
their judgment and record such events on a special form created for this study.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care