BIS Monitoring to Detect Deep Sedation

NCT02203344 | Completed DMC

• 1 other identifier: KY2014-05--013
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder; Mental, Sedative; Depressed Level of Consciousness; Mechanical Ventilation Complication; Psychosis Associated With Intensive Care

Outcome Measures

Primary Outcomes (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.

  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.

  15 minutes before and after RASS evaluation

Secondary Outcomes (2)

• Incidence of deep sedation

  24 hours after establishing of BIS monitoring

• Occurrence of deep sedation during day- and night-time

  24 hours after establishing of BIS monitoring

Study Arms (2)

Light sedation

Light sedation is defined as RASS of +1 to -2.

Deep sedation

Deep sedation is defined as RASS of -3 to -5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead
• Beijing Municipal Health Bureau: collaborator

Study Sites (1)

Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University

Beijing, Beijing Municipality, 102600, China

Location

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jian-Xin Zhou, MD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 29, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

CN (1)