xml: <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/NCT05962996</url>
    </required_header>
    <id_info>
      <org_study_id>DR230092</org_study_id>
      <secondary_id>2023-A00712-43</secondary_id>
      <nct_id>NCT05962996</nct_id>
    </id_info>
    <brief_title>Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit (PUPICAT)</brief_title>
    <acronym>PUPICAT</acronym>
    <official_title>Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Régional Universitaire de Tours</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centre Hospitalier Régional d'Orléans</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre Hospitalier Régional Universitaire de Tours</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>
        Pain is common in intensive care and gives rise to multiple consequences that can impact the&#xD;
        future of patients. The placement of deep venous catheters are painful gestures of common&#xD;
        practice in intensive care. However, some patients are ventilated and sedated and their level&#xD;
        of pain is difficult to judge. Quantitative pupillometry seems to be a reliable tool for&#xD;
        assessing pain in these patients unable to communicate. The method is already common practice&#xD;
        in the operating room for this indication and recent studies increasingly validate its use in&#xD;
        intensive care.&#xD;
  &#xD;
        The aim of the study is to validate the different levels of pain that can be assessed by&#xD;
        pupillometry within this population during catheterization and to identify any non-responding&#xD;
        subgroups (in order to conduct future clinical trials evaluating pain therapies).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Three groups of patients will be studied : with aminergic drugs / with curare / without&#xD;
        aminergic drugs nor curare.&#xD;
  &#xD;
        The measurement of pain levels by quantitative pupillometry (NPi®-200 pupillometer,&#xD;
        NeurOptics® USA) will be made in intubated, sedated patients, unable to communicate on their&#xD;
        level of pain during the placement of a deep venous catheter.&#xD;
  &#xD;
        Pain will be evaluated before starting the placement of the catheter, at puncture(s), at&#xD;
        dilation(s), and during the suture of the catheter.&#xD;
  &#xD;
        Simultaneously, RASS and BPS scores as well as the patient's vital parameters and the&#xD;
        cumulative doses of sedation-analgesia, curare and aminergic drugs will be collected.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>Change in variation of pupillary diameter by quantitative pupillometry</measure>
      <time_frame>During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)</time_frame>
      <description>Pupillary variation (%) = [maximum pupil diameter (mm) - minimum pupil diameter (mm)] / maximum pupil diameter (mm)]</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in pupillary reflex latency by quantitative pupillometry</measure>
      <time_frame>During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)</time_frame>
      <description>Latency of pupillary reflex in seconds</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in pupil constriction by quantitative pupillometry</measure>
      <time_frame>During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)</time_frame>
      <description>Pupil constriction speed in mm/s</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in pupil dilatation by quantitative pupillometry</measure>
      <time_frame>During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)</time_frame>
      <description>Pupil dilation speed in mm/s</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in NPi by quantitative pupillometry</measure>
      <time_frame>During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)</time_frame>
      <description>Neurological Pupil Index (NPi), from 0 to 4.9, higher scores meaning a better outcome (normal pupillary light reflex)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in BPS scores</measure>
      <time_frame>During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)</time_frame>
      <description>Behavioural Pain Scale scores : from 3 to 12, higher scores meaning a worse outcome (more pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in respiratory rate</measure>
      <time_frame>During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)</time_frame>
      <description>Respiratory rate (cycles per minute)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in heart rate</measure>
      <time_frame>During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)</time_frame>
      <description>Heart rate (beats per minute)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in blood pressure</measure>
      <time_frame>During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)</time_frame>
      <description>Blood pressure (mmHg)</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Critical Illness</condition>
    <arm_group>
      <arm_group_label>Amines</arm_group_label>
      <description>Sedated and intubated patients requiring a deep venous catheter, unable to communicate their level of pain, and treated with aminergic drugs (no curare) Assessment of pain levels by pupillometry during the placement of the deep venous catheter</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Curares</arm_group_label>
      <description>Sedated and intubated patients requiring a deep venous catheter, unable to communicate their level of pain, and treated with curares (no aminergic drug) Assessment of pain levels by pupillometry during the placement of the deep venous catheter</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sedation alone</arm_group_label>
      <description>Sedated and intubated patients requiring a deep venous catheter, unable to communicate their level of pain, without any aminergic drug nor curare Assessment of pain levels by pupillometry during the placement of the deep venous catheter</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Pupillometry</intervention_name>
      <description>Measurement of pain levels by pupillometry during the insertion of a deep venous catheter</description>
      <arm_group_label>Amines</arm_group_label>
      <arm_group_label>Curares</arm_group_label>
      <arm_group_label>Sedation alone</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients admitted in ICU, sedated, intubated, unable to communicate their levels of pain&#xD;
          and requiring the placement of a deep venous catheter&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient aged over 18 hospitalized in Intensive Care Unit&#xD;
  &#xD;
            -  Requiring the placement of a deep venous catheter (central venous catheter or dialysis&#xD;
               catheter)&#xD;
  &#xD;
            -  Sedated, intubated, unable to communicate about pain&#xD;
  &#xD;
            -  No opposition to participation in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any ophthalmological pathology (lesion of the orbital cavity, edematous soft tissue or&#xD;
               with an open lesion)&#xD;
  &#xD;
            -  Any intracranial pathology (stroke, subarachnoid hemorrhage, tumour, etc.)&#xD;
  &#xD;
            -  Patient post-cardio-respiratory arrest within the first 48 hours&#xD;
  &#xD;
            -  Medicines interfering with the pupillary reflex: clonidine dexmedetomidine,&#xD;
               droperidol, metoclopramide, nitric oxide, scopolamine, atropine&#xD;
  &#xD;
            -  Patient protected within the law&#xD;
  &#xD;
            -  Previous participation in the study&#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_contact>
      <last_name>Ambre Sauvage</last_name>
      <phone>247474747</phone>
      <phone_ext>+33</phone_ext>
      <email>asauvage.isp@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sophie Jacquier, MD</last_name>
      <email>S.JACQUIER@chu-tours.fr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Centre Hospitalier Régional Universitaire de Tours</investigator_affiliation>
      <investigator_full_name>Ambre Sauvage</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Pupillometry</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>
  
  
text: 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/NCT05962996
  org study id: DR230092
  secondary id: 2023-A00712-43
  nct id: NCT05962996
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Pain is common in intensive care and gives rise to multiple consequences that can impact the
        future of patients. The placement of deep venous catheters are painful gestures of common
        practice in intensive care. However, some patients are ventilated and sedated and their level
        of pain is difficult to judge. Quantitative pupillometry seems to be a reliable tool for
        assessing pain in these patients unable to communicate. The method is already common practice
        in the operating room for this indication and recent studies increasingly validate its use in
        intensive care.
  
        The aim of the study is to validate the different levels of pain that can be assessed by
        pupillometry within this population during catheterization and to identify any non-responding
        subgroups (in order to conduct future clinical trials evaluating pain therapies).
  Three groups of patients will be studied : with aminergic drugs / with curare / without
        aminergic drugs nor curare.
  
        The measurement of pain levels by quantitative pupillometry (NPi®-200 pupillometer,
        NeurOptics® USA) will be made in intubated, sedated patients, unable to communicate on their
        level of pain during the placement of a deep venous catheter.
  
        Pain will be evaluated before starting the placement of the catheter, at puncture(s), at
        dilation(s), and during the suture of the catheter.
  
        Simultaneously, RASS and BPS scores as well as the patient's vital parameters and the
        cumulative doses of sedation-analgesia, curare and aminergic drugs will be collected.
  observational model: Other
  time perspective: Prospective
  measure: Change in variation of pupillary diameter by quantitative pupillometry
  time frame: During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)
  description: Pupillary variation (%) = [maximum pupil diameter (mm) - minimum pupil diameter (mm)] / maximum pupil diameter (mm)]
  measure: Changes in pupillary reflex latency by quantitative pupillometry
  time frame: During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)
  description: Latency of pupillary reflex in seconds
  measure: Changes in pupil constriction by quantitative pupillometry
  time frame: During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)
  description: Pupil constriction speed in mm/s
  measure: Changes in pupil dilatation by quantitative pupillometry
  time frame: During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)
  description: Pupil dilation speed in mm/s
  measure: Changes in NPi by quantitative pupillometry
  time frame: During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)
  description: Neurological Pupil Index (NPi), from 0 to 4.9, higher scores meaning a better outcome (normal pupillary light reflex)
  measure: Changes in BPS scores
  time frame: During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)
  description: Behavioural Pain Scale scores : from 3 to 12, higher scores meaning a worse outcome (more pain)
  measure: Changes in respiratory rate
  time frame: During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)
  description: Respiratory rate (cycles per minute)
  measure: Changes in heart rate
  time frame: During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)
  description: Heart rate (beats per minute)
  measure: Changes in blood pressure
  time frame: During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)
  description: Blood pressure (mmHg)
  arm group label: Amines
  description: Sedated and intubated patients requiring a deep venous catheter, unable to communicate their level of pain, and treated with aminergic drugs (no curare) Assessment of pain levels by pupillometry during the placement of the deep venous catheter
  arm group label: Curares
  description: Sedated and intubated patients requiring a deep venous catheter, unable to communicate their level of pain, and treated with curares (no aminergic drug) Assessment of pain levels by pupillometry during the placement of the deep venous catheter
  arm group label: Sedation alone
  description: Sedated and intubated patients requiring a deep venous catheter, unable to communicate their level of pain, without any aminergic drug nor curare Assessment of pain levels by pupillometry during the placement of the deep venous catheter
  intervention type: Device
  intervention name: Pupillometry
  description: Measurement of pain levels by pupillometry during the insertion of a deep venous catheter
  arm group label: Amines
  arm group label: Curares
  arm group label: Sedation alone
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ambre Sauvage
  phone: 247474747
  phone ext: +33
  email: asauvage.isp@gmail.com
  last name: Sophie Jacquier, MD
  email: S.JACQUIER@chu-tours.fr
  responsible party type: Principal Investigator
  investigator affiliation: Centre Hospitalier Régional Universitaire de Tours
  investigator full name: Ambre Sauvage
  investigator title: Principal Investigator
  mesh term: Critical Illness