<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/NCT01669486</url>
  </required_header>
  <id_info>
    <org_study_id>1514</org_study_id>
    <nct_id>NCT01669486</nct_id>
  </id_info>
  <brief_title>The Pain in Intensive Care Unit: Different Rating System Comparing</brief_title>
  <acronym>ICPain</acronym>
  <official_title>The Pain in Intensive Care Unit: An Experimental Research to Compare Behavioural Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi dell'Insubria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi dell'Insubria</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to find the best system for assessing the pain of critically&#xD;
      ill patient in Intensive Care Unit (ICU).&#xD;
&#xD;
      At first the investigators assess the sedation of the patient with the scale&#xD;
      sedation-agitation scale (SAS) or the delirium with the confusion assessment method, if the&#xD;
      patient is too sedated or delirious the investigators consider him unable to use the Visual&#xD;
      Analogic Scale (VAS).&#xD;
&#xD;
      The investigators compare two different scales Critical Care Pain Observation Tool (CPOT) and&#xD;
      Behavioural Pain Scale (BPS) which include no verbal items. Each items has been evaluated in&#xD;
      three different moments: before, during and after the nurses' care.&#xD;
&#xD;
      The investigators compare the scales between them. Then, every time the investigators value&#xD;
      the score of these scales with the self-report of patients with the VAS scale (when it is&#xD;
      possible) and finally with the physiological parameters (blood pressure, heart rate and&#xD;
      respiratory rate).&#xD;
&#xD;
      In the end, the investigators compare two different classes of patient: the surgical and&#xD;
      medical one. The investigators search for some differences in the perception of the pain&#xD;
      between these two classes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has specific aims:&#xD;
&#xD;
        1. to find the best method to evaluate the pain in critically ill patients;&#xD;
&#xD;
        2. to compare the perception of pain analysed trough CPOT and BPS;&#xD;
&#xD;
        3. to compare CPOT and BPS between medical and surgical patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>The evaluation of pain in critically ill patients</measure>
    <time_frame>Participants will be followed for 3 days</time_frame>
    <description>The measurement of pain with no verbal items of different pain scales: facial expression, movements of the body, muscle tone, compliance of mechanical ventilation, movements of the arms. We'll evaluate the level of pain before and after nurses manoeuvers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The comparisation beetween the CPOT and the BPS scales</measure>
    <time_frame>Participants will be followed for 3 days</time_frame>
    <description>The comparisation beetween the different items of two scales: CPOT (facial expression, movements of the body, muscle tone, compliance of mechanical ventilation) and BPS (facial expression, movements of the arms, compliance of mechanical ventilation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The comparisation of CPOT and BPS between medical and surgical critically ill patients</measure>
    <time_frame>Participants will be followed for 3 days</time_frame>
    <description>We'll measure facial expression, movements of the body, muscle tone, compliance of mechanical ventilation, movements of the arms, according with BPS and CPOT scores in two classes of patient: the surgical and medical critically ill patients.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>ICU patients</arm_group_label>
    <description>All patients admitted to ICU for a minimal hospitalization of 24 hours, invasive mechanically ventilated, will be evaluated with CPOT and BPS scores, during nurses work, in particular before and after nurses manoeuvers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CPOT, BPS</intervention_name>
    <description>Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.</description>
    <arm_group_label>ICU patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult male and female Critically ill patients Mechanically ventilated patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male and female&#xD;
&#xD;
          -  require of Mechanical Ventilation (MV)&#xD;
&#xD;
          -  Hospitalization on ICU &gt; 24 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Tetraplegic&#xD;
&#xD;
          -  Neuromuscolar disease&#xD;
&#xD;
          -  Neuromuscolar blocking agents by continuous infusion&#xD;
&#xD;
          -  Spontaneous breathing without Mechanical Ventilation (MV)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paolo MD Severgnini, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Universita' degli Studi dell'Insubria, Varese, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda ospedaliera ospedale Circolo e Fondazione Macchi</name>
      <address>
        <city>Varese</city>
        <zip>21100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>June 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>April 22, 2013</last_update_submitted>
  <last_update_submitted_qc>April 22, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 23, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi dell'Insubria</investigator_affiliation>
    <investigator_full_name>Paolo Severgnini</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>ICU</keyword>
  <keyword>Mechanical ventilation</keyword>
  <keyword>CPOT</keyword>
  <keyword>BPS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT01669486
org study id: 1514
nct id: NCT01669486
lead sponsor: 
has dmc: Yes
The purpose of this research is to find the best system for assessing the pain of critically
      ill patient in Intensive Care Unit (ICU).

      At first the investigators assess the sedation of the patient with the scale
      sedation-agitation scale (SAS) or the delirium with the confusion assessment method, if the
      patient is too sedated or delirious the investigators consider him unable to use the Visual
      Analogic Scale (VAS).

      The investigators compare two different scales Critical Care Pain Observation Tool (CPOT) and
      Behavioural Pain Scale (BPS) which include no verbal items. Each items has been evaluated in
      three different moments: before, during and after the nurses' care.

      The investigators compare the scales between them. Then, every time the investigators value
      the score of these scales with the self-report of patients with the VAS scale (when it is
      possible) and finally with the physiological parameters (blood pressure, heart rate and
      respiratory rate).

      In the end, the investigators compare two different classes of patient: the surgical and
      medical one. The investigators search for some differences in the perception of the pain
      between these two classes.
This study has specific aims:

        1. to find the best method to evaluate the pain in critically ill patients;

        2. to compare the perception of pain analysed trough CPOT and BPS;

        3. to compare CPOT and BPS between medical and surgical patients.
observational model: Cohort
time perspective: Prospective
measure: The evaluation of pain in critically ill patients
time frame: Participants will be followed for 3 days
description: The measurement of pain with no verbal items of different pain scales: facial expression, movements of the body, muscle tone, compliance of mechanical ventilation, movements of the arms. We'll evaluate the level of pain before and after nurses manoeuvers
measure: The comparisation beetween the CPOT and the BPS scales
time frame: Participants will be followed for 3 days
description: The comparisation beetween the different items of two scales: CPOT (facial expression, movements of the body, muscle tone, compliance of mechanical ventilation) and BPS (facial expression, movements of the arms, compliance of mechanical ventilation).
measure: The comparisation of CPOT and BPS between medical and surgical critically ill patients
time frame: Participants will be followed for 3 days
description: We'll measure facial expression, movements of the body, muscle tone, compliance of mechanical ventilation, movements of the arms, according with BPS and CPOT scores in two classes of patient: the surgical and medical critically ill patients.
arm group label: ICU patients
description: All patients admitted to ICU for a minimal hospitalization of 24 hours, invasive mechanically ventilated, will be evaluated with CPOT and BPS scores, during nurses work, in particular before and after nurses manoeuvers.
intervention type: Other
intervention name: CPOT, BPS
description: Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.
arm group label: ICU patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Paolo MD Severgnini, Prof.
role: Study Director
affiliation: Universita' degli Studi dell'Insubria, Varese, Italy
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi dell'Insubria
investigator full name: Paolo Severgnini
investigator title: Prof.
mesh term: Critical Illness