<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/NCT04472247</url>
  </required_header>
  <id_info>
    <org_study_id>Responsiveness</org_study_id>
    <nct_id>NCT04472247</nct_id>
  </id_info>
  <brief_title>Sedation Monitoring Using Frontal Electroencephalogram, Electromyogram and Hemodynamic Responses to Pain in Critical Care</brief_title>
  <official_title>Sedation Monitoring Using Frontal Electroencephalogram, Electromyogram and Hemodynamic Responses to Pain in Critical Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Helsinki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Helsinki</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: Assessing nociception and sedation in mechanically ventilated patients in the ICU is&#xD;
      challenging, with few reliable methods available for continuous monitoring. Measurable&#xD;
      cardiovascular and neurophysiological variables, such as blood pressure, heart rate, frontal&#xD;
      EEG, and frontal EMG, might provide a medium for sedation and nociception monitoring. The&#xD;
      hypothesis of this explorative study is that the aforementioned variables correlate with the&#xD;
      level of sedation, as described by the Richmond Agitation-Sedation score (RASS).&#xD;
&#xD;
      Methods: Thirty adult postoperative ICU patients on mechanical ventilation and receiving&#xD;
      intravenous sedation, excluding patients with primary neurological disorders, head injury, or&#xD;
      need for continuous neuromuscular blockage. Continuous measurements of bispectral index&#xD;
      (BIS), EMG power (EMG), EMG-derived Responsiveness Index (RI), averaged blood pressure&#xD;
      variability (ARV), and Surgical Pleth Index (SPI) were tested against repeated RASS&#xD;
      measurements, and separately against responsiveness to painful stimuli at varying RASS&#xD;
      levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 7, 2007</start_date>
  <completion_date type="Actual">April 1, 2009</completion_date>
  <primary_completion_date type="Actual">April 1, 2009</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>EEG and EMG variables correlate with the level of sedation (as measured by the established RASS score), and are reactive with nociceptive stimulation.</measure>
    <time_frame>2 (1-3) days from admission to ICU</time_frame>
    <description>Noninvasive neuromonitoring variables are collected and analysed against the RASS score, which quantifies patient's sedation level.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Electroencephalography</condition>
  <condition>Critical Care</condition>
  <condition>Electromyography</condition>
  <arm_group>
    <arm_group_label>Critical Care Patients</arm_group_label>
    <description>Critical care patients requiring mechanical ventilation via an endotracheal tube, with invasive hemodynamic monitoring via an arterial line, and receiving intravenous sedation by continuous infusion (propofol, midazolam).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Continuous EEG and EMG monitoring, with derived variables</intervention_name>
    <description>All patients are monitored during their ICU stay by frontal EEG and EMG measuring devides, which are already in clinical use.</description>
    <arm_group_label>Critical Care Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Postoperative patients, requiring postoperative critical care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (over 18 years old)&#xD;
&#xD;
          -  Postoperative ICU admission (planned and un-planned admissions), on mechanical&#xD;
             ventilation via an endotracheal tube, with invasive hemodynamic monitoring via an&#xD;
             arterial line&#xD;
&#xD;
          -  receiving intravenous sedation by continuous infusion (propofol, midazolam).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        primary neurological disorders (including stroke, cardiac arrest with probable hypoxic&#xD;
        brain injury, intracranial hemorrhage, and head injury with reduced level of consciousness&#xD;
        prior to intubation), the continuous use of neuromuscular blocking agents during&#xD;
        monitoring, confirmed meningitis or encephalitis, or a short data collection time (less&#xD;
        than 12 hours).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care</name>
      <address>
        <city>Helsinki</city>
        <state>Uudenmaan Lääni</state>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsinki University Central Hospital, Department of Cardiac Surgery</name>
      <address>
        <city>Helsinki</city>
        <state>Uudenmaan Lääni</state>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <results_reference>
    <citation>Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.</citation>
    <PMID>23269131</PMID>
  </results_reference>
  <results_reference>
    <citation>Ball J. How useful is the bispectral index in the management of ICU patients? Minerva Anestesiol. 2002 Apr;68(4):248-51.</citation>
    <PMID>12024092</PMID>
  </results_reference>
  <results_reference>
    <citation>Fraser GL, Riker RR. Bispectral index monitoring in the intensive care unit provides more signal than noise. Pharmacotherapy. 2005 May;25(5 Pt 2):19S-27S. doi: 10.1592/phco.2005.25.5_part_2.19s.</citation>
    <PMID>15899745</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 11, 2020</last_update_submitted>
  <last_update_submitted_qc>July 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Helsinki</investigator_affiliation>
    <investigator_full_name>Juhani Akseli Stewart</investigator_full_name>
    <investigator_title>Dr. Juhani Stewart, MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04472247
org study id: Responsiveness
nct id: NCT04472247
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose: Assessing nociception and sedation in mechanically ventilated patients in the ICU is
      challenging, with few reliable methods available for continuous monitoring. Measurable
      cardiovascular and neurophysiological variables, such as blood pressure, heart rate, frontal
      EEG, and frontal EMG, might provide a medium for sedation and nociception monitoring. The
      hypothesis of this explorative study is that the aforementioned variables correlate with the
      level of sedation, as described by the Richmond Agitation-Sedation score (RASS).

      Methods: Thirty adult postoperative ICU patients on mechanical ventilation and receiving
      intravenous sedation, excluding patients with primary neurological disorders, head injury, or
      need for continuous neuromuscular blockage. Continuous measurements of bispectral index
      (BIS), EMG power (EMG), EMG-derived Responsiveness Index (RI), averaged blood pressure
      variability (ARV), and Surgical Pleth Index (SPI) were tested against repeated RASS
      measurements, and separately against responsiveness to painful stimuli at varying RASS
      levels.
observational model: Cohort
time perspective: Prospective
measure: EEG and EMG variables correlate with the level of sedation (as measured by the established RASS score), and are reactive with nociceptive stimulation.
time frame: 2 (1-3) days from admission to ICU
description: Noninvasive neuromonitoring variables are collected and analysed against the RASS score, which quantifies patient's sedation level.
arm group label: Critical Care Patients
description: Critical care patients requiring mechanical ventilation via an endotracheal tube, with invasive hemodynamic monitoring via an arterial line, and receiving intravenous sedation by continuous infusion (propofol, midazolam).
intervention type: Diagnostic Test
intervention name: Continuous EEG and EMG monitoring, with derived variables
description: All patients are monitored during their ICU stay by frontal EEG and EMG measuring devides, which are already in clinical use.
arm group label: Critical Care Patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Finland
citation: Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
PMID: 23269131
citation: Ball J. How useful is the bispectral index in the management of ICU patients? Minerva Anestesiol. 2002 Apr;68(4):248-51.
PMID: 12024092
citation: Fraser GL, Riker RR. Bispectral index monitoring in the intensive care unit provides more signal than noise. Pharmacotherapy. 2005 May;25(5 Pt 2):19S-27S. doi: 10.1592/phco.2005.25.5_part_2.19s.
PMID: 15899745
responsible party type: Principal Investigator
investigator affiliation: University of Helsinki
investigator full name: Juhani Akseli Stewart
investigator title: Dr. Juhani Stewart, MD
sharing ipd: No