An observational study in Disorder; Mental, Sedative, Depressed Level of Consciousness and Mechanical Ventilation Complication, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-12-30.
Sponsored by Capital Medical University · Observational
Studies have shown that prolonged deep sedation is associated with adverse clinical outcomes in adult intensive care unit (ICU) patients. The revised guidelines for management of pain, agitation and delirium by the Society of Critical Care Medicine in 2013 also recommended that adult ICU patients should be maintained at a light level of sedation. The key point in light sedation strategy is the assessment of depth of sedation. At present, sedation is monitored mainly by the subjective clinical score systems, such as the Ramsay Scale, the Riker's Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS). However, the subjective and intermittent nature of these scales instruments has limited their application in light sedation algorithm. Consequently, objective and continuous measurement of the level of sedation would be more desirable in clinical practice. In recent years, objective measures of brain function have been of great interests in the evaluation of sedation level, and bispectral index (BIS) has been the most investigated instrument.
Several studies compared BIS with subjective sedation scales in adult ICU patients, and yielded conflicting results. The different approaches to select BIS value may be the most important reason for these inconsistent agreements between BIS and subjective sedation scales. A formal scheme of subjective assessment of the depth of sedation and level of consciousness should incorporate exerting verbal and physical stimuli and observation of the patient's subsequent responses. Our primary aim is to clarify the diagnostic accuracy of BIS in detecting early deep sedation against the reference standard of subjective scale instrument. We hypothesize that BIS monitoring will provide accurate, subjective and continuous evaluation of deepen sedation.
236 studies on the registry are indexed under Consciousness Disorders; 101 are open to participants now.
This study's enrollment of 45 is below the median of 79 across 86 observational studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.
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Adult patients admitted to a 22-bed general ICU in a University Affiliated Hospital will be screened daily and enrolled consecutively.
Exclusion Criteria:
Light sedation is defined as RASS of +1 to -2.
Deep sedation is defined as RASS of -3 to -5
The primary aim of present study is to determine the diagnostic accuracy of BIS monitoring for detecting deep sedation against the reference standard of RASS.
According to RASS evaluation, observations in each time point will be stratified into 2 situations: light sedation (RASS= 0 to -2) and deep sedation (RASS= -3 to -5). Receiver operator characteristic (ROC) curve analysis will be applied to determine the probability of BIS values in predicting deep sedation.
Time frame: 15 minutes before and after RASS evaluation
Incidence of deep sedation
Time frame: 24 hours after establishing of BIS monitoring
Occurrence of deep sedation during day- and night-time
Day-time is defined as 8AM to 8PM, and night-time as 8PM to 8AM.
Time frame: 24 hours after establishing of BIS monitoring
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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