BIS Monitoring to Detect Deep Sedation
|ClinicalTrials.gov Identifier: NCT02203344|
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : December 30, 2014
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.
|Condition or disease|
|Disorder; Mental, Sedative Depressed Level of Consciousness Mechanical Ventilation Complication Psychosis Associated With Intensive Care|
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Official Title:||Use of Bispectral Index Monitoring as an Alert to Detect Deep Sedation in Mechanical Ventilated Patients: a Prospective Observational Study|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||December 2014|
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. [ Time Frame: 15 minutes before and after RASS evaluation ]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.
- Incidence of deep sedation [ Time Frame: 24 hours after establishing of BIS monitoring ]
- Occurrence of deep sedation during day- and night-time [ Time Frame: 24 hours after establishing of BIS monitoring ]Day-time is defined as 8AM to 8PM, and night-time as 8PM to 8AM.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203344
|Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University|
|Beijing, Beijing, China, 102600|
|Principal Investigator:||Jian-Xin Zhou, MD||Capital Medical University|