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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Start Date
January 1, 2014
Primary Completion Date
June 1, 2015
Completion Date
December 1, 2015
Last Updated
February 19, 2016
19
ACTUAL participants
sedation monitoring with RASS score
OTHER
sedation monitoring with BIS-Guided monitoring
OTHER
Lead Sponsor
Englewood Hospital and Medical Center
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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