<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/NCT03024528</url>
  </required_header>
  <id_info>
    <org_study_id>POL-CPOT</org_study_id>
    <nct_id>NCT03024528</nct_id>
  </id_info>
  <brief_title>Validation of the Polish Version of CPOT</brief_title>
  <acronym>POL-CPOT</acronym>
  <official_title>Validation of the Polish Version of CPOT (Critical Care Pain Observation Tool) to Assess Pain Intensity in Adult, Intubated ICU Patients, POL-CPOT.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pomeranian Medical University Szczecin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pomeranian Medical University Szczecin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain experienced by critically ill patients is a major problem affecting nearly 50% of the&#xD;
      patients. Assessing pain in critically ill patients is a challenge even in an intensive care&#xD;
      unit (ICU) with a minimal opioid-based sedation protocol. In patients who are unable to&#xD;
      self-report pain, behavioural scales are used, such as CPOT - Critical Care Pain Observation&#xD;
      Tool.&#xD;
&#xD;
      Aim: The aim of this study was to validate the Polish version of a behavioural pain&#xD;
      assessment method - CPOT in an ICU with a minimal sedation protocol (opioid-based) versus&#xD;
      self-report pain using Numeric rating scale (NRS) in both delirious and non-delirious&#xD;
      patients (assessed using Confusion Assessment Method for ICU, CAM-ICU).&#xD;
&#xD;
      Method: A prospective observational cohort study will include 70 patients. The patients will&#xD;
      be observed during a non-nociceptive procedure (wash of an arm) and a nociceptive procedure&#xD;
      (turning). Patients will be observed 5 minutes before, during, and 15 min after the two&#xD;
      interventions (six assessments). Each CPOT assessment will be carried out by two observers&#xD;
      blinded to each other. To validate the Polish CPOT translation calculations of interrater&#xD;
      reliability, criterion validity and discriminant validity will be performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Critically ill patients frequently suffer from pain during their stay in the intensive care&#xD;
      unit, as nearly 30% of those patients experience pain at rest and up to 50% experience pain&#xD;
      during nursing procedures. Pain experienced by critically ill patients falls into four&#xD;
      categories that coexist and overlap: pre-existing chronic pain, acute illness-related pain,&#xD;
      continuous ICU treatment-related pain or discomfort and intermittent procedural pain.&#xD;
      Moreover, acute pain experienced in the ICU may become a chronic problem after discharge from&#xD;
      the unit, as a lifelong ICU footprint. Everyday nursing procedures and interventions (i.e.&#xD;
      positioning, mouth and trachea suctioning, wound care, catheter removal or placement,&#xD;
      cannulation or intubation) performed in the ICU may be a potential source of pain, therefore&#xD;
      there is a clinical need for a simple and easy ICU pain scale to evaluate this condition in&#xD;
      patients unable to self-report pain.&#xD;
&#xD;
      Assessment of pain in patients treated in the ICU becomes a daily clinical challenge for the&#xD;
      ICU team, especially in those units where deep levels of sedation are used, but also in the&#xD;
      minimal sedation environment based on analgesia. Various guidelines and recommendations exist&#xD;
      to guide the ICU care team in the pain management and assessment process. Nevertheless, the&#xD;
      gold standard for pain assessment is patient's self-report of pain (using numeric raing scale&#xD;
      - NRS or visual analog scale - VAS), which can be aided with behavioural scales only when the&#xD;
      self-report is unreliable or impossible to obtain. Those observational pain scales include&#xD;
      the Critical-Care Pain Observation Tool (CPOT) and the Behavioural Pain Scale (BPS) and have&#xD;
      been recommended for clinical use in the critically ill adults. However, their validation in&#xD;
      a given patient population (cardiac, burn, different languages) is strongly recommended and&#xD;
      required.&#xD;
&#xD;
      The need to equip critical care teams with dedicated monitoring tools is clear as early&#xD;
      identification warrants early treatment. The CPOT has been developed by ICU professionals,&#xD;
      yet it has not been translated or validated in Polish until now.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</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>Interrater variability for Polish CPOT</measure>
    <time_frame>Through study completion and up to 24 weeks.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Criterion validity for Polish CPOT</measure>
    <time_frame>Through study completion and up to 24 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminant validity for Polish CPOT</measure>
    <time_frame>Through study completion and up to 24 weeks.</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">71</enrollment>
  <condition>Pain</condition>
  <condition>ICU Delirium</condition>
  <arm_group>
    <arm_group_label>CAM-ICU (+)</arm_group_label>
    <description>Delirious patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAM-ICU (-)</arm_group_label>
    <description>Non-delirious patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CPOT assessment</intervention_name>
    <description>Polish version of Critical care pain observation tool validation.</description>
    <arm_group_label>CAM-ICU (+)</arm_group_label>
    <arm_group_label>CAM-ICU (-)</arm_group_label>
    <other_name>Pain assessment in non-verbal patients</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Intubated adult ICU patients at the Intensive Care Unit of the Department of Anaesthesia,&#xD;
        Intensive Care and Acute Poisoning of the tertiary teaching hospital at the Pomeranian&#xD;
        Medical University in Szczecin, Poland undergoing minimal analgesia-based sedation protocol&#xD;
        (fentanyl or morphine intravenous infusion).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 18 years,&#xD;
&#xD;
          -  Ability to communicate in the Polish language,&#xD;
&#xD;
          -  Intubated or with tracheostomy for more than 48 hours before inclusion with or without&#xD;
             mechanical ventilation (controlled modes, spontaneous modes),&#xD;
&#xD;
          -  Richmond Agitation Sedation Scale (RASS) above or equal to -3,&#xD;
&#xD;
          -  Unrestricted sight and hearing,&#xD;
&#xD;
          -  No limitations for body position changing,&#xD;
&#xD;
          -  With no important intervention within last 48 hours prior to inclusion into the study&#xD;
             (i.e. operation, tracheostomy).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A medical need for deep sedation - treatment of severe respiratory failure associated&#xD;
             with patient-ventilator dyssynchrony, preventing awareness during neuromuscular&#xD;
             blockade, status epilepticus, certain surgical conditions requiring immobility , cases&#xD;
             of severe brain injury with intracranial hypertension&#xD;
&#xD;
          -  Facial trauma (unable to evaluate facial expression),&#xD;
&#xD;
          -  Richmond Agitation Sedation Scale (RASS) -4 or -5&#xD;
&#xD;
          -  Neurological or psychiatric disorders,&#xD;
&#xD;
          -  Use of neuromuscular blocking agents,&#xD;
&#xD;
          -  Regular narcotic users,&#xD;
&#xD;
          -  Chronic pain syndrome patients.&#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>Katarzyna L Kotfis, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pomeranian Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pomeranian Medical University</name>
      <address>
        <city>Szczecin</city>
        <zip>70-111</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>April 20, 2017</last_update_submitted>
  <last_update_submitted_qc>April 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pomeranian Medical University Szczecin</investigator_affiliation>
    <investigator_full_name>Katarzyna Kotfis</investigator_full_name>
    <investigator_title>MD, PhD, DESA</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>CPOT</keyword>
  <keyword>ICU Delirium</keyword>
  <keyword>Critical Care Pain Observation Tool</keyword>
  <keyword>NRS</keyword>
  <keyword>Behaviour</keyword>
  <keyword>Critical care</keyword>
  <keyword>Intensive Care</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>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 8, 2019</submitted>
    <returned>July 18, 2019</returned>
  </pending_results>
  <!-- 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/NCT03024528
org study id: POL-CPOT
nct id: NCT03024528
lead sponsor: 
has dmc: No
Pain experienced by critically ill patients is a major problem affecting nearly 50% of the
      patients. Assessing pain in critically ill patients is a challenge even in an intensive care
      unit (ICU) with a minimal opioid-based sedation protocol. In patients who are unable to
      self-report pain, behavioural scales are used, such as CPOT - Critical Care Pain Observation
      Tool.

      Aim: The aim of this study was to validate the Polish version of a behavioural pain
      assessment method - CPOT in an ICU with a minimal sedation protocol (opioid-based) versus
      self-report pain using Numeric rating scale (NRS) in both delirious and non-delirious
      patients (assessed using Confusion Assessment Method for ICU, CAM-ICU).

      Method: A prospective observational cohort study will include 70 patients. The patients will
      be observed during a non-nociceptive procedure (wash of an arm) and a nociceptive procedure
      (turning). Patients will be observed 5 minutes before, during, and 15 min after the two
      interventions (six assessments). Each CPOT assessment will be carried out by two observers
      blinded to each other. To validate the Polish CPOT translation calculations of interrater
      reliability, criterion validity and discriminant validity will be performed.
Critically ill patients frequently suffer from pain during their stay in the intensive care
      unit, as nearly 30% of those patients experience pain at rest and up to 50% experience pain
      during nursing procedures. Pain experienced by critically ill patients falls into four
      categories that coexist and overlap: pre-existing chronic pain, acute illness-related pain,
      continuous ICU treatment-related pain or discomfort and intermittent procedural pain.
      Moreover, acute pain experienced in the ICU may become a chronic problem after discharge from
      the unit, as a lifelong ICU footprint. Everyday nursing procedures and interventions (i.e.
      positioning, mouth and trachea suctioning, wound care, catheter removal or placement,
      cannulation or intubation) performed in the ICU may be a potential source of pain, therefore
      there is a clinical need for a simple and easy ICU pain scale to evaluate this condition in
      patients unable to self-report pain.

      Assessment of pain in patients treated in the ICU becomes a daily clinical challenge for the
      ICU team, especially in those units where deep levels of sedation are used, but also in the
      minimal sedation environment based on analgesia. Various guidelines and recommendations exist
      to guide the ICU care team in the pain management and assessment process. Nevertheless, the
      gold standard for pain assessment is patient's self-report of pain (using numeric raing scale
      - NRS or visual analog scale - VAS), which can be aided with behavioural scales only when the
      self-report is unreliable or impossible to obtain. Those observational pain scales include
      the Critical-Care Pain Observation Tool (CPOT) and the Behavioural Pain Scale (BPS) and have
      been recommended for clinical use in the critically ill adults. However, their validation in
      a given patient population (cardiac, burn, different languages) is strongly recommended and
      required.

      The need to equip critical care teams with dedicated monitoring tools is clear as early
      identification warrants early treatment. The CPOT has been developed by ICU professionals,
      yet it has not been translated or validated in Polish until now.
observational model: Cohort
time perspective: Prospective
measure: Interrater variability for Polish CPOT
time frame: Through study completion and up to 24 weeks.
measure: Criterion validity for Polish CPOT
time frame: Through study completion and up to 24 weeks.
measure: Discriminant validity for Polish CPOT
time frame: Through study completion and up to 24 weeks.
arm group label: CAM-ICU (+)
description: Delirious patients.
arm group label: CAM-ICU (-)
description: Non-delirious patients
intervention type: Behavioral
intervention name: CPOT assessment
description: Polish version of Critical care pain observation tool validation.
arm group label: CAM-ICU (+)
arm group label: CAM-ICU (-)
other name: Pain assessment in non-verbal patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katarzyna L Kotfis, MD,PhD
role: Principal Investigator
affiliation: Pomeranian Medical University
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Pomeranian Medical University Szczecin
investigator full name: Katarzyna Kotfis
investigator title: MD, PhD, DESA
mesh term: Delirium
sharing ipd: No
submitted: May 8, 2019
returned: July 18, 2019