<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/NCT03840577</url>
  </required_header>
  <id_info>
    <org_study_id>3880</org_study_id>
    <nct_id>NCT03840577</nct_id>
  </id_info>
  <brief_title>BIS-Guided Sedation in Critically Ill Patients Under Deep Sedation</brief_title>
  <official_title>Effect of Bispectral Index (BIS)-Guided Sedation on Delirium and Sedative Drug Requirements in Critically Ill Patients Under Deep Sedation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Italiano de Buenos Aires</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Italiano de Buenos Aires</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical trial is to investigate the effectiveness of sedation guided by the&#xD;
      bispectral index (BIS) in reducing the incidence of delirium and the doses of sedative drugs&#xD;
      used in critical patients who require deep sedation. The main questions this study aims to&#xD;
      answer are:&#xD;
&#xD;
        -  Does sedation guided by BIS lead to higher delirium and coma-free days compared to&#xD;
           clinical monitoring?&#xD;
&#xD;
        -  Does sedation guided by BIS result in reduced doses of sedative drugs compared to&#xD;
           clinical monitoring?&#xD;
&#xD;
      Participants in this study will be randomly assigned to one of two groups:&#xD;
&#xD;
      Clinical Monitoring Group: Participants in this group will receive sedation based on clinical&#xD;
      scales. These participants will also be fitted with a BIS sensor, but the sensor will be&#xD;
      covered.&#xD;
&#xD;
      Sedation Guided by BIS Group: Participants in this group will receive sedation guided by the&#xD;
      bispectral index.&#xD;
&#xD;
      The study will be conducted as a prospective, controlled, blind intervention trial with&#xD;
      random distribution and intention to treat. The primary outcomes to be evaluated include:&#xD;
&#xD;
        -  Delirium and coma-free days after the end of deep sedation using the Confusion&#xD;
           Assessment Method for the ICU (CAM-ICU) scale.&#xD;
&#xD;
        -  Total dose of sedative drugs administered.&#xD;
&#xD;
        -  BIS values&#xD;
&#xD;
      Researchers will compare the two groups to determine if sedation guided by BIS is associated&#xD;
      with a higher number of delirium and coma-free days, reduced sedative drug doses, and higher&#xD;
      values of BIS compared to clinical monitoring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase 4, randomized (1:1), controlled, double-blind, unicenter clinical trial aims to&#xD;
      assess the effectiveness of sedation guided by the Bispectral Index (BIS) compared to&#xD;
      sedation guided by clinical scales in critically ill patients under deep sedation. The&#xD;
      primary objective is to investigate whether BIS-guided sedation can reduce the incidence of&#xD;
      delirium and decrease the doses of sedative drugs administered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Actual">April 22, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will be assigned according to the randomization to clinical monitoring groups or Bispectral Index (BIS) monitoring group. The ranzomization will be stratified randomization by neuromuscular bloquers.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The primary outcome &quot;Compare delirium and coma-free days until 14 days after the end of deep sedation&quot; will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale. The evaluations will be conducted by blinded evaluators who are unaware of the patient's assigned sedation management group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Compare delirium and coma free days until 14 days after end of deep sedation</measure>
    <time_frame>Up to 14 days post end of deep sedation</time_frame>
    <description>To compare the number of Delirium and Coma-Free Days until day 14 after the cessation of deep sedation in patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales. Delirium will be assessed using the CAM-ICU scale (Ely EW et al.) by non-ICU researchers who are blinded to the randomization allocation. The delirium evaluation will begin when the patient reaches a Richmond Agitation-Sedation Scale (RASS) score of &gt; -3.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare the doses of sedative drugs received</measure>
    <time_frame>From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days</time_frame>
    <description>To compare the total doses of Propofol, Midazolam, and Remifentanil (calculated in mg/kg) received during the period of deep sedation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare values of BIS</measure>
    <time_frame>From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days</time_frame>
    <description>To compare the values of Bispectral Index (BIS) in patients receiving sedation guided by the Bispectral Index (BIS) versus sedation guided by clinical scales. This outcome will assess the BIS values recorded during the period of deep sedation and compare them between the two groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time with values of BIS less than 40</measure>
    <time_frame>From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days</time_frame>
    <description>To compare the number of hours that patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales had registered Bispectral Index (BIS) values below 40 during the period of deep sedation. The duration of time with BIS values below 40 will be recorded for each patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare days alive and free of the ICU</measure>
    <time_frame>From date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 120 days</time_frame>
    <description>To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on days alive and free of the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare days alive and free of the hospital</measure>
    <time_frame>From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 120 days</time_frame>
    <description>To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on days alive and free of the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare days alive and free of mechanical ventilation through Study Day 30</measure>
    <time_frame>From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 30 days</time_frame>
    <description>To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on the number of days alive and free of mechanical ventilation through Study Day 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare days alive and free of mechanical ventilation through Study Day 60</measure>
    <time_frame>From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 60 days</time_frame>
    <description>To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on the number of days alive and free of mechanical ventilation through Study Day 60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare delirium and coma free days until 14 days after end of deep sedation in patients who had more than 24 hours of deep sedation</measure>
    <time_frame>Up to 14 days post end of deep sedation</time_frame>
    <description>To compare the number of Delirium and Coma-Free Days until day 14 after the cessation of deep sedation in patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales. Delirium will be assessed using the CAM-ICU scale (Ely EW et al.) by non-ICU researchers who are blinded to the randomization allocation. The delirium evaluation will begin when the patient reaches a Richmond Agitation-Sedation Scale (RASS) score of &gt; -3, in patients who had more than 24 hours of deep sedation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Compare mortality at 60 days after randomization</measure>
    <time_frame>Until 60 days after randomization</time_frame>
    <description>To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on mortality at 60 days after randomization</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Delirium</condition>
  <condition>Sedative Overdose</condition>
  <arm_group>
    <arm_group_label>Sedation guided by Clinical Scales</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Sedative guided by RASS (Richmond Agitation-Sedation Scale) score. Target RASS: -4 / -5.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sedation guided by Bispectral Index</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sedation guided by the Bispectral Index (BIS). Target BIS between 40 to 60.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Monitorization of sedation by Bispectral Index</intervention_name>
    <description>The sedative dose administered through a continuous infusion pump will be adjusted based on the BIS value to maintain a target range of 40 to 60. If the BIS value is below the target range, the dose will be increased, and if it exceeds the range, the dose will be decreased, aiming to keep the BIS within the desired range.</description>
    <arm_group_label>Sedation guided by Bispectral Index</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years.&#xD;
&#xD;
          -  Under mechanical ventilation in the intensive care unit&#xD;
&#xD;
          -  Indication of deep sedation (RASS objective -4, -5)&#xD;
&#xD;
          -  Admission to the ICU or indication of deep sedation up to 8 hours prior to&#xD;
             randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with end-of-life care.&#xD;
&#xD;
          -  Family refusal to participate in the study.&#xD;
&#xD;
          -  Impossibility to place the BIS sensor (burns, extensive lesions on the forehead, prone&#xD;
             position, etc.).&#xD;
&#xD;
          -  Patients with intracranial hypertension or convulsive status, in whom sedation has the&#xD;
             objective of suppressing electroencephalographic waves.&#xD;
&#xD;
          -  Patients who, following a decrease in sedation, have a coma, vegetative state or a&#xD;
             state of minimal consciousness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sergio Giannasi, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Italiano de Buenos Aires</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Federico Carini, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Italiano de Buenos Aires</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ivan A. Huespe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Italiano de Buenos Aires</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Italiano de Buenos Aires</name>
      <address>
        <city>Capital Federal</city>
        <zip>1173</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <reference>
    <citation>MacKenzie KK, Britt-Spells AM, Sands LP, Leung JM. Processed Electroencephalogram Monitoring and Postoperative Delirium: A Systematic Review and Meta-analysis. Anesthesiology. 2018 Sep;129(3):417-427. doi: 10.1097/ALN.0000000000002323.</citation>
    <PMID>29912008</PMID>
  </reference>
  <reference>
    <citation>Salluh JI, Soares M, Teles JM, Ceraso D, Raimondi N, Nava VS, Blasquez P, Ugarte S, Ibanez-Guzman C, Centeno JV, Laca M, Grecco G, Jimenez E, Arias-Rivera S, Duenas C, Rocha MG; Delirium Epidemiology in Critical Care Study Group. Delirium epidemiology in critical care (DECCA): an international study. Crit Care. 2010;14(6):R210. doi: 10.1186/cc9333. Epub 2010 Nov 23.</citation>
    <PMID>21092264</PMID>
  </reference>
  <reference>
    <citation>Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.</citation>
    <PMID>11445689</PMID>
  </reference>
  <reference>
    <citation>Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.</citation>
    <PMID>30113379</PMID>
  </reference>
  <reference>
    <citation>Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.</citation>
    <PMID>12421743</PMID>
  </reference>
  <reference>
    <citation>Shetty RM, Bellini A, Wijayatilake DS, Hamilton MA, Jain R, Karanth S, Namachivayam A. BIS monitoring versus clinical assessment for sedation in mechanically ventilated adults in the intensive care unit and its impact on clinical outcomes and resource utilization. Cochrane Database Syst Rev. 2018 Feb 21;2(2):CD011240. doi: 10.1002/14651858.CD011240.pub2.</citation>
    <PMID>29464690</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>February 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Italiano de Buenos Aires</investigator_affiliation>
    <investigator_full_name>Ivan A Huespe, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Deep Sedation</keyword>
  <keyword>Bispectral index</keyword>
  <keyword>Critical care patients</keyword>
  <keyword>Delirium</keyword>
  <keyword>Sedatives</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data will be made available upon reasonable request.</ipd_description>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>The data will be made available at the end of the study, in 2024.</ipd_time_frame>
    <ipd_access_criteria>All data requirements will be evaluated by the principal investigator and the local Institutional Review Board to ensure compliance with ethical and regulatory guidelines regarding data access and protection</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03840577
org study id: 3880
nct id: NCT03840577
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The goal of this clinical trial is to investigate the effectiveness of sedation guided by the
      bispectral index (BIS) in reducing the incidence of delirium and the doses of sedative drugs
      used in critical patients who require deep sedation. The main questions this study aims to
      answer are:

        -  Does sedation guided by BIS lead to higher delirium and coma-free days compared to
           clinical monitoring?

        -  Does sedation guided by BIS result in reduced doses of sedative drugs compared to
           clinical monitoring?

      Participants in this study will be randomly assigned to one of two groups:

      Clinical Monitoring Group: Participants in this group will receive sedation based on clinical
      scales. These participants will also be fitted with a BIS sensor, but the sensor will be
      covered.

      Sedation Guided by BIS Group: Participants in this group will receive sedation guided by the
      bispectral index.

      The study will be conducted as a prospective, controlled, blind intervention trial with
      random distribution and intention to treat. The primary outcomes to be evaluated include:

        -  Delirium and coma-free days after the end of deep sedation using the Confusion
           Assessment Method for the ICU (CAM-ICU) scale.

        -  Total dose of sedative drugs administered.

        -  BIS values

      Researchers will compare the two groups to determine if sedation guided by BIS is associated
      with a higher number of delirium and coma-free days, reduced sedative drug doses, and higher
      values of BIS compared to clinical monitoring.
A Phase 4, randomized (1:1), controlled, double-blind, unicenter clinical trial aims to
      assess the effectiveness of sedation guided by the Bispectral Index (BIS) compared to
      sedation guided by clinical scales in critically ill patients under deep sedation. The
      primary objective is to investigate whether BIS-guided sedation can reduce the incidence of
      delirium and decrease the doses of sedative drugs administered.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be assigned according to the randomization to clinical monitoring groups or Bispectral Index (BIS) monitoring group. The ranzomization will be stratified randomization by neuromuscular bloquers.
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
masking description: The primary outcome "Compare delirium and coma-free days until 14 days after the end of deep sedation" will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale. The evaluations will be conducted by blinded evaluators who are unaware of the patient's assigned sedation management group
measure: Compare delirium and coma free days until 14 days after end of deep sedation
time frame: Up to 14 days post end of deep sedation
description: To compare the number of Delirium and Coma-Free Days until day 14 after the cessation of deep sedation in patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales. Delirium will be assessed using the CAM-ICU scale (Ely EW et al.) by non-ICU researchers who are blinded to the randomization allocation. The delirium evaluation will begin when the patient reaches a Richmond Agitation-Sedation Scale (RASS) score of > -3.
measure: Compare the doses of sedative drugs received
time frame: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
description: To compare the total doses of Propofol, Midazolam, and Remifentanil (calculated in mg/kg) received during the period of deep sedation
measure: Compare values of BIS
time frame: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
description: To compare the values of Bispectral Index (BIS) in patients receiving sedation guided by the Bispectral Index (BIS) versus sedation guided by clinical scales. This outcome will assess the BIS values recorded during the period of deep sedation and compare them between the two groups
measure: Time with values of BIS less than 40
time frame: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
description: To compare the number of hours that patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales had registered Bispectral Index (BIS) values below 40 during the period of deep sedation. The duration of time with BIS values below 40 will be recorded for each patient.
measure: Compare days alive and free of the ICU
time frame: From date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 120 days
description: To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on days alive and free of the ICU
measure: Compare days alive and free of the hospital
time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 120 days
description: To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on days alive and free of the hospital
measure: Compare days alive and free of mechanical ventilation through Study Day 30
time frame: From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 30 days
description: To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on the number of days alive and free of mechanical ventilation through Study Day 30
measure: Compare days alive and free of mechanical ventilation through Study Day 60
time frame: From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 60 days
description: To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on the number of days alive and free of mechanical ventilation through Study Day 60
measure: Compare delirium and coma free days until 14 days after end of deep sedation in patients who had more than 24 hours of deep sedation
time frame: Up to 14 days post end of deep sedation
description: To compare the number of Delirium and Coma-Free Days until day 14 after the cessation of deep sedation in patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales. Delirium will be assessed using the CAM-ICU scale (Ely EW et al.) by non-ICU researchers who are blinded to the randomization allocation. The delirium evaluation will begin when the patient reaches a Richmond Agitation-Sedation Scale (RASS) score of > -3, in patients who had more than 24 hours of deep sedation
measure: Compare mortality at 60 days after randomization
time frame: Until 60 days after randomization
description: To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on mortality at 60 days after randomization
arm group label: Sedation guided by Clinical Scales
arm group type: No Intervention
description: Sedative guided by RASS (Richmond Agitation-Sedation Scale) score. Target RASS: -4 / -5.
arm group label: Sedation guided by Bispectral Index
arm group type: Experimental
description: Sedation guided by the Bispectral Index (BIS). Target BIS between 40 to 60.
intervention type: Device
intervention name: Monitorization of sedation by Bispectral Index
description: The sedative dose administered through a continuous infusion pump will be adjusted based on the BIS value to maintain a target range of 40 to 60. If the BIS value is below the target range, the dose will be increased, and if it exceeds the range, the dose will be decreased, aiming to keep the BIS within the desired range.
arm group label: Sedation guided by Bispectral Index
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sergio Giannasi, MD
role: Study Chair
affiliation: Hospital Italiano de Buenos Aires
last name: Federico Carini, MD
role: Study Director
affiliation: Hospital Italiano de Buenos Aires
last name: Ivan A. Huespe, MD
role: Principal Investigator
affiliation: Hospital Italiano de Buenos Aires
facility: 
country: Argentina
citation: MacKenzie KK, Britt-Spells AM, Sands LP, Leung JM. Processed Electroencephalogram Monitoring and Postoperative Delirium: A Systematic Review and Meta-analysis. Anesthesiology. 2018 Sep;129(3):417-427. doi: 10.1097/ALN.0000000000002323.
PMID: 29912008
citation: Salluh JI, Soares M, Teles JM, Ceraso D, Raimondi N, Nava VS, Blasquez P, Ugarte S, Ibanez-Guzman C, Centeno JV, Laca M, Grecco G, Jimenez E, Arias-Rivera S, Duenas C, Rocha MG; Delirium Epidemiology in Critical Care Study Group. Delirium epidemiology in critical care (DECCA): an international study. Crit Care. 2010;14(6):R210. doi: 10.1186/cc9333. Epub 2010 Nov 23.
PMID: 21092264
citation: Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.
PMID: 11445689
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responsible party type: Principal Investigator
investigator affiliation: Hospital Italiano de Buenos Aires
investigator full name: Ivan A Huespe, MD
investigator title: Principal Investigator
mesh term: Delirium
sharing ipd: Yes
ipd description: Individual participant data will be made available upon reasonable request.
ipd info type: Analytic Code
ipd time frame: The data will be made available at the end of the study, in 2024.
ipd access criteria: All data requirements will be evaluated by the principal investigator and the local Institutional Review Board to ensure compliance with ethical and regulatory guidelines regarding data access and protection