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CompletedNCT02203344Updated Dec 30, 2014

BIS Monitoring to Detect Deep Sedation

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

Study type
Observational
Time perspective
Prospective
Enrollment
45
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Disorder; Mental, Sedative
  • Depressed Level of Consciousness
  • Mechanical Ventilation Complication
  • Psychosis Associated With Intensive Care
03

In context

Consciousness Disorders

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 →

Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
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Study design

Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • Light sedation

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

  • Deep sedation

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

06

What researchers measure

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.

    Time frame: 15 minutes before and after RASS evaluation

Secondary outcomes

  1. Incidence of deep sedation

    Time frame: 24 hours after establishing of BIS monitoring

  2. 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

07

Study locations

1 site
  • Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University
    Beijing, Beijing 102600, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02203344
Lead sponsor
Capital Medical University
Collaborators
Beijing Municipal Health Bureau
Responsible party
Jian-Xin Zhou (Professor, Capital Medical University) — Principal investigator
First posted
Jul 29, 2014
Start date
Aug 2014
Primary completion
Nov 2014
Completion
Dec 2014
Last update
Dec 30, 2014

Study contacts

Jian-Xin Zhou, MD
principal investigator · Capital Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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