<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/NCT03273244</url>
  </required_header>
  <id_info>
    <org_study_id>FWOAL768</org_study_id>
    <nct_id>NCT03273244</nct_id>
  </id_info>
  <brief_title>Measuring Comfort During Palliative Sedation</brief_title>
  <acronym>COMPAS</acronym>
  <official_title>Towards a Better Understanding of What Palliative Sedated Patients Experience: Linking Numbers to Experiences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vrije Universiteit Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vrije Universiteit Brussel</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>
      Background. In case of untreatable suffering at the end of life, palliative sedation may be&#xD;
      chosen to assure comfort by reducing the patient's level of consciousness. An important&#xD;
      question here is whether such sedated patients are certainly completely free of pain. Because&#xD;
      these patients cannot communicate anymore, caregivers have to rely on observation to assess&#xD;
      the patient's comfort. Recently however, more sophisticated techniques from the neurosciences&#xD;
      (fMRI, EEG) have shown that sometimes consciousness and pain is undetectable with these&#xD;
      traditional behavioral methods.&#xD;
&#xD;
      Therefore there is an urgent need for a more reliable way of assessment by combining existing&#xD;
      observational scales, subjective assessments of caregivers and family and neuroimaging&#xD;
      techniques.&#xD;
&#xD;
      Aim. The aim of this study is to better understand how unconscious palliative sedated&#xD;
      patients experience the last days of their life and to find out if they are really free of&#xD;
      pain.&#xD;
&#xD;
      Methods In this study the investigators will observe 40 patients starting with initiation of&#xD;
      palliative sedation until death.&#xD;
&#xD;
      Assessment of comfort based on behavioural observations will be related with the results from&#xD;
      a NeuroSense monitor, an EEG-based brain monitor used for evaluation of the adequacy of&#xD;
      anesthesia and sedation in the operating room and an ECG-based Analgesia Nociception Index&#xD;
      (ANI) monitor, which informs about the comfort or discomfort condition of the organism, based&#xD;
      on the parasympathetic tone (including calculation of ANI). Additionally, the researchers&#xD;
      will investigate whether changes of these measures can be linked to changes in the patients'&#xD;
      experience as observed by caregivers and relatives, especially in the last moments of life.&#xD;
      An innovative and challenging aspect of this study is its qualitative approach, implying all&#xD;
      the different types of data will be used to link &quot;objective&quot; and &quot;subjective&quot; data to achieve&#xD;
      a holistic understanding of the study topics.&#xD;
&#xD;
      The following data will be collected:&#xD;
&#xD;
        -  assessment of pain/comfort by the patients themselves before loss of consciousness due&#xD;
           to deep continuous sedation (if possible) by scoring a Visual Analogue Scale (VAS)&#xD;
&#xD;
        -  brain function monitoring (NeuroSense monitor)&#xD;
&#xD;
        -  monitoring of parasympathetic tone (ANI monitor)&#xD;
&#xD;
        -  assessment by caregivers on 3 VAS scales (different scales or 3 different caregivers?)&#xD;
&#xD;
        -  relatives' perception of the quality of the dying process on 3 VAS scales (idem)&#xD;
&#xD;
        -  assessment by 2 trained investigators using observational scales&#xD;
&#xD;
        -  observation: video and audio registration&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 12, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Level of awareness</measure>
    <time_frame>From date of enrollment until the date of death, on average less than 1 week.</time_frame>
    <description>Level of awareness as measured by a NeuroSense monitor and expressed as the WAVcns index (Wavelet-based Anesthetic Value for Central Nervous System). The WAVcns is based on cortical EEG.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of pain and discomfort</measure>
    <time_frame>From date of enrollment until the date of death, on average less than 1 week.</time_frame>
    <description>Level of pain and discomfort as measured by an ANI-monitor and expressed by the analgesia nociception index (ANI). The ANI is based on HRV (heart rate variability).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.</time_frame>
    <description>Visual analog score assessment by nurse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Awareness</measure>
    <time_frame>From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.</time_frame>
    <description>Visual analog score assessment by nurse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Communication</measure>
    <time_frame>From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.</time_frame>
    <description>Visual analog score assessment by nurse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.</time_frame>
    <description>Visual analog score assessment by family member</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Awareness</measure>
    <time_frame>From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.</time_frame>
    <description>Visual analog score assessment by family member</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Communication</measure>
    <time_frame>From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.</time_frame>
    <description>Visual analog score assessment by family member</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Palliative Sedation</condition>
  <arm_group>
    <arm_group_label>Device monitoring</arm_group_label>
    <description>NeuroSense monitoring and ANI monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NeuroSense monitoring and ANI monitoring</intervention_name>
    <description>From the start of palliative sedation, monitoring of EEG with NeuroSense device (WAVcns: Wavelet Anesthetic Value of the Central Nervous System) and ANI-monitoring (Analgesia Nociception Index) will be initiated.</description>
    <arm_group_label>Device monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients older than 18 years where palliative sedation is expected to be initiated,&#xD;
        regardless of underlying diseases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients may be included if they are considered by their treating physician as:&#xD;
&#xD;
          1. in their last week of life&#xD;
&#xD;
          2. in conditions that might, when not treated, cause high levels of distress&#xD;
&#xD;
          3. sedated&#xD;
&#xD;
          4. unable to communicate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Reginald Deschepper, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Vrije Universiteit Brussel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Sint-Blasius</name>
      <address>
        <city>Dendermonde</city>
        <state>Oost-Vlaanderen</state>
        <zip>9200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>October 17, 2019</last_update_submitted>
  <last_update_submitted_qc>October 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vrije Universiteit Brussel</investigator_affiliation>
    <investigator_full_name>Stefaan Six</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03273244
org study id: FWOAL768
nct id: NCT03273244
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background. In case of untreatable suffering at the end of life, palliative sedation may be
      chosen to assure comfort by reducing the patient's level of consciousness. An important
      question here is whether such sedated patients are certainly completely free of pain. Because
      these patients cannot communicate anymore, caregivers have to rely on observation to assess
      the patient's comfort. Recently however, more sophisticated techniques from the neurosciences
      (fMRI, EEG) have shown that sometimes consciousness and pain is undetectable with these
      traditional behavioral methods.

      Therefore there is an urgent need for a more reliable way of assessment by combining existing
      observational scales, subjective assessments of caregivers and family and neuroimaging
      techniques.

      Aim. The aim of this study is to better understand how unconscious palliative sedated
      patients experience the last days of their life and to find out if they are really free of
      pain.

      Methods In this study the investigators will observe 40 patients starting with initiation of
      palliative sedation until death.

      Assessment of comfort based on behavioural observations will be related with the results from
      a NeuroSense monitor, an EEG-based brain monitor used for evaluation of the adequacy of
      anesthesia and sedation in the operating room and an ECG-based Analgesia Nociception Index
      (ANI) monitor, which informs about the comfort or discomfort condition of the organism, based
      on the parasympathetic tone (including calculation of ANI). Additionally, the researchers
      will investigate whether changes of these measures can be linked to changes in the patients'
      experience as observed by caregivers and relatives, especially in the last moments of life.
      An innovative and challenging aspect of this study is its qualitative approach, implying all
      the different types of data will be used to link "objective" and "subjective" data to achieve
      a holistic understanding of the study topics.

      The following data will be collected:

        -  assessment of pain/comfort by the patients themselves before loss of consciousness due
           to deep continuous sedation (if possible) by scoring a Visual Analogue Scale (VAS)

        -  brain function monitoring (NeuroSense monitor)

        -  monitoring of parasympathetic tone (ANI monitor)

        -  assessment by caregivers on 3 VAS scales (different scales or 3 different caregivers?)

        -  relatives' perception of the quality of the dying process on 3 VAS scales (idem)

        -  assessment by 2 trained investigators using observational scales

        -  observation: video and audio registration
observational model: Other
time perspective: Prospective
measure: Level of awareness
time frame: From date of enrollment until the date of death, on average less than 1 week.
description: Level of awareness as measured by a NeuroSense monitor and expressed as the WAVcns index (Wavelet-based Anesthetic Value for Central Nervous System). The WAVcns is based on cortical EEG.
measure: Level of pain and discomfort
time frame: From date of enrollment until the date of death, on average less than 1 week.
description: Level of pain and discomfort as measured by an ANI-monitor and expressed by the analgesia nociception index (ANI). The ANI is based on HRV (heart rate variability).
measure: Pain
time frame: From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.
description: Visual analog score assessment by nurse
measure: Awareness
time frame: From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.
description: Visual analog score assessment by nurse
measure: Communication
time frame: From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.
description: Visual analog score assessment by nurse
measure: Pain
time frame: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.
description: Visual analog score assessment by family member
measure: Awareness
time frame: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.
description: Visual analog score assessment by family member
measure: Communication
time frame: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.
description: Visual analog score assessment by family member
arm group label: Device monitoring
description: NeuroSense monitoring and ANI monitoring
intervention type: Device
intervention name: NeuroSense monitoring and ANI monitoring
description: From the start of palliative sedation, monitoring of EEG with NeuroSense device (WAVcns: Wavelet Anesthetic Value of the Central Nervous System) and ANI-monitoring (Analgesia Nociception Index) will be initiated.
arm group label: Device monitoring
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Reginald Deschepper, PhD
role: Study Chair
affiliation: Vrije Universiteit Brussel
facility: 
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Vrije Universiteit Brussel
investigator full name: Stefaan Six
investigator title: Principal Investigator