<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02203344</url>
  </required_header>
  <id_info>
    <org_study_id>KY2014-05--013</org_study_id>
    <nct_id>NCT02203344</nct_id>
  </id_info>
  <brief_title>BIS Monitoring to Detect Deep Sedation</brief_title>
  <official_title>Use of Bispectral Index Monitoring as an Alert to Detect Deep Sedation in Mechanical Ventilated Patients: a Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Municipal Health Bureau</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Capital Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies have shown that prolonged deep sedation is associated with adverse clinical outcomes&#xD;
      in adult intensive care unit (ICU) patients. The revised guidelines for management of pain,&#xD;
      agitation and delirium by the Society of Critical Care Medicine in 2013 also recommended that&#xD;
      adult ICU patients should be maintained at a light level of sedation. The key point in light&#xD;
      sedation strategy is the assessment of depth of sedation. At present, sedation is monitored&#xD;
      mainly by the subjective clinical score systems, such as the Ramsay Scale, the Riker's&#xD;
      Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS). However, the&#xD;
      subjective and intermittent nature of these scales instruments has limited their application&#xD;
      in light sedation algorithm. Consequently, objective and continuous measurement of the level&#xD;
      of sedation would be more desirable in clinical practice. In recent years, objective measures&#xD;
      of brain function have been of great interests in the evaluation of sedation level, and&#xD;
      bispectral index (BIS) has been the most investigated instrument.&#xD;
&#xD;
      Several studies compared BIS with subjective sedation scales in adult ICU patients, and&#xD;
      yielded conflicting results. The different approaches to select BIS value may be the most&#xD;
      important reason for these inconsistent agreements between BIS and subjective sedation&#xD;
      scales. A formal scheme of subjective assessment of the depth of sedation and level of&#xD;
      consciousness should incorporate exerting verbal and physical stimuli and observation of the&#xD;
      patient's subsequent responses. Our primary aim is to clarify the diagnostic accuracy of BIS&#xD;
      in detecting early deep sedation against the reference standard of subjective scale&#xD;
      instrument. We hypothesize that BIS monitoring will provide accurate, subjective and&#xD;
      continuous evaluation of deepen sedation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>15 minutes before and after RASS evaluation</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of deep sedation</measure>
    <time_frame>24 hours after establishing of BIS monitoring</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of deep sedation during day- and night-time</measure>
    <time_frame>24 hours after establishing of BIS monitoring</time_frame>
    <description>Day-time is defined as 8AM to 8PM, and night-time as 8PM to 8AM.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Disorder; Mental, Sedative</condition>
  <condition>Depressed Level of Consciousness</condition>
  <condition>Mechanical Ventilation Complication</condition>
  <condition>Psychosis Associated With Intensive Care</condition>
  <arm_group>
    <arm_group_label>Light sedation</arm_group_label>
    <description>Light sedation is defined as RASS of +1 to -2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deep sedation</arm_group_label>
    <description>Deep sedation is defined as RASS of -3 to -5</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients admitted to a 22-bed general ICU in a University Affiliated Hospital will be&#xD;
        screened daily and enrolled consecutively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients are intubated and ventilated within the previous 24 hours, are&#xD;
             administered with continuous or intermittent intravenous sedatives and/or analgesics,&#xD;
             and are expected to receive mechanical ventilation and sedation for longer than 24&#xD;
             hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18 or over 65 years;&#xD;
&#xD;
          -  Continuously infusion of muscle relaxants;&#xD;
&#xD;
          -  Diagnosed or suspected brain diseases, which including brain trauma, intracranial&#xD;
             hemorrhage, stroke, brain tumors, hypoxic-ischemic encephalopathy, epilepsy and&#xD;
             meningitis;&#xD;
&#xD;
          -  Diagnosed conditions that resulted in a decrease level of consciousness, which&#xD;
             including hypoxemia with partial pressure of oxygen in arterial blood less than 60&#xD;
             mmHg, hypotension with systolic blood pressure less than 90 mmHg, hypoglycemia with&#xD;
             blood glucose concentration less than 4.1 mmol/L, anemia with hemoglobin concentration&#xD;
             less than 70 g/L, and body temperature below 36 °C.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jian-Xin Zhou, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Capital Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>102600</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>December 24, 2014</last_update_submitted>
  <last_update_submitted_qc>December 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Jian-Xin Zhou</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Consciousness Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02203344
org study id: KY2014-05--013
nct id: NCT02203344
lead sponsor: 
collaborator: 
has dmc: Yes
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.
time perspective: Prospective
measure: 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
description: 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.
measure: Incidence of deep sedation
time frame: 24 hours after establishing of BIS monitoring
measure: Occurrence of deep sedation during day- and night-time
time frame: 24 hours after establishing of BIS monitoring
description: Day-time is defined as 8AM to 8PM, and night-time as 8PM to 8AM.
arm group label: Light sedation
description: Light sedation is defined as RASS of +1 to -2.
arm group label: Deep sedation
description: Deep sedation is defined as RASS of -3 to -5
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jian-Xin Zhou, MD
role: Principal Investigator
affiliation: Capital Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Jian-Xin Zhou
investigator title: Professor
mesh term: Consciousness Disorders
mesh term: Mental Disorders