<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/NCT03832764</url>
  </required_header>
  <id_info>
    <org_study_id>2017/1517</org_study_id>
    <nct_id>NCT03832764</nct_id>
  </id_info>
  <brief_title>Non-invasive Pain Monitoring in Post-operative Patients</brief_title>
  <acronym>ANSPEC</acronym>
  <official_title>Observational Study for the Evaluation of a New Non-invasive Painmonitor Used in Clinic in Awakening, Postoperative Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Ghent</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>
      During the current pain monitoring system the patient is awake and he/she is asked to give a&#xD;
      numerical scale rating from 0 (no pain) to 10 (extreme pain). The purpose is to correlate the&#xD;
      non-invasive measurements of the prototype device ANSPEC-PRO with these numbers to develop&#xD;
      later a method/algorithm for automatic evaluation of pain (objective measurement of pain).&#xD;
      The measurement is done using standard ECG electrodes placed in the hand palm of the patient.&#xD;
      The patient feels nothing during the observations, perhaps irritation of skin may occur as&#xD;
      result of long time measurement. As a comparison to the investigators prototype, a commercial&#xD;
      device is also used in (randomly selected) patients, i.e. the MedStorm device.&#xD;
&#xD;
      The study will try to answer the following questions:&#xD;
&#xD;
        -  Are the measurements with the ANSPEC-PRO correlated with the NRS values?&#xD;
&#xD;
        -  What is the (mathematical) relationship between the measured values and the NRS?&#xD;
&#xD;
        -  Is there difference between the two devices in measuring pain levels? And what is this&#xD;
           difference if pain alleviation medication is given to the patient?&#xD;
&#xD;
        -  A number of 26 patients is envisaged for this study, equally distributed to be evaluated&#xD;
           with the two devices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">June 26, 2018</completion_date>
  <primary_completion_date type="Actual">June 26, 2018</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>Evaluation of a new non-invasive painmonitor used in clinic awakening, postoperative patients.</measure>
    <time_frame>140 minutes each patient</time_frame>
    <description>Pain monitoring of awake patients which are standardly treated for pain using the numerical rating scale. The main outcome is a correlation between ANSPEC-PRO device and the numerical rating scale.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">26</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>ANSPEC-PRO</arm_group_label>
    <description>These patients are selected (after randomized selection) to be monitored non-invasively for pain level via prototype ANSPEC-PRO - correlated to a NRS number given by the awake patient in PACU/ICU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDSTORM</arm_group_label>
    <description>These patients are selected (after randomized selection) to be monitored non-invasively for pain level via MEDSTORM - correlated to a NRS number given by the awake patient in PACU/ICU.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ANSPEC-PRO</intervention_name>
    <description>Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU</description>
    <arm_group_label>ANSPEC-PRO</arm_group_label>
    <arm_group_label>MEDSTORM</arm_group_label>
    <other_name>MEDSTORM</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients planned for operation, between 18 and 70 years old, not pregnant, not in chronic&#xD;
        pain and not taken anticonvulsants or antidepressants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients postoperative of a painfull operation&#xD;
&#xD;
          -  between 18 and70 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  day surgery patients&#xD;
&#xD;
          -  chronic pain patients&#xD;
&#xD;
          -  taken medication : anticonvulsants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clara Ionescu</name>
      <address>
        <city>Ghent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 11, 2018</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>skin impedance</keyword>
  <keyword>pain monitoring</keyword>
  <keyword>observational study</keyword>
  <keyword>PACU/ICU</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT03832764
org study id: 2017/1517
nct id: NCT03832764
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
During the current pain monitoring system the patient is awake and he/she is asked to give a
      numerical scale rating from 0 (no pain) to 10 (extreme pain). The purpose is to correlate the
      non-invasive measurements of the prototype device ANSPEC-PRO with these numbers to develop
      later a method/algorithm for automatic evaluation of pain (objective measurement of pain).
      The measurement is done using standard ECG electrodes placed in the hand palm of the patient.
      The patient feels nothing during the observations, perhaps irritation of skin may occur as
      result of long time measurement. As a comparison to the investigators prototype, a commercial
      device is also used in (randomly selected) patients, i.e. the MedStorm device.

      The study will try to answer the following questions:

        -  Are the measurements with the ANSPEC-PRO correlated with the NRS values?

        -  What is the (mathematical) relationship between the measured values and the NRS?

        -  Is there difference between the two devices in measuring pain levels? And what is this
           difference if pain alleviation medication is given to the patient?

        -  A number of 26 patients is envisaged for this study, equally distributed to be evaluated
           with the two devices.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of a new non-invasive painmonitor used in clinic awakening, postoperative patients.
time frame: 140 minutes each patient
description: Pain monitoring of awake patients which are standardly treated for pain using the numerical rating scale. The main outcome is a correlation between ANSPEC-PRO device and the numerical rating scale.
arm group label: ANSPEC-PRO
description: These patients are selected (after randomized selection) to be monitored non-invasively for pain level via prototype ANSPEC-PRO - correlated to a NRS number given by the awake patient in PACU/ICU.
arm group label: MEDSTORM
description: These patients are selected (after randomized selection) to be monitored non-invasively for pain level via MEDSTORM - correlated to a NRS number given by the awake patient in PACU/ICU.
intervention type: Device
intervention name: ANSPEC-PRO
description: Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU
arm group label: ANSPEC-PRO
arm group label: MEDSTORM
other name: MEDSTORM
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Pain, Postoperative