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BIS Monitoring to Detect Deep Sedation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02203344
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : December 30, 2014
Beijing Municipal Health Bureau
Information provided by (Responsible Party):
Jian-Xin Zhou, Capital Medical University

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 45 participants
Time Perspective: Prospective
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
Light sedation is defined as RASS of +1 to -2.
Deep sedation
Deep sedation is defined as RASS of -3 to -5

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Incidence of deep sedation [ Time Frame: 24 hours after establishing of BIS monitoring ]
  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients admitted to a 22-bed general ICU in a University Affiliated Hospital will be screened daily and enrolled consecutively.

Inclusion Criteria:

  • Adult patients are intubated and ventilated within the previous 24 hours, are administered with continuous or intermittent intravenous sedatives and/or analgesics, and are expected to receive mechanical ventilation and sedation for longer than 24 hours

Exclusion Criteria:

  • Age under 18 or over 65 years;
  • Continuously infusion of muscle relaxants;
  • Diagnosed or suspected brain diseases, which including brain trauma, intracranial hemorrhage, stroke, brain tumors, hypoxic-ischemic encephalopathy, epilepsy and meningitis;
  • Diagnosed conditions that resulted in a decrease level of consciousness, which including hypoxemia with partial pressure of oxygen in arterial blood less than 60 mmHg, hypotension with systolic blood pressure less than 90 mmHg, hypoglycemia with blood glucose concentration less than 4.1 mmol/L, anemia with hemoglobin concentration less than 70 g/L, and body temperature below 36 °C.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02203344

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China, Beijing
Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University
Beijing, Beijing, China, 102600
Sponsors and Collaborators
Capital Medical University
Beijing Municipal Health Bureau
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Principal Investigator: Jian-Xin Zhou, MD Capital Medical University
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Responsible Party: Jian-Xin Zhou, Professor, Capital Medical University Identifier: NCT02203344    
Other Study ID Numbers: KY2014-05--013
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Consciousness Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders