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/NCT06025370</url>
    </required_header>
    <id_info>
      <org_study_id>CHRO-2022-13</org_study_id>
      <nct_id>NCT06025370</nct_id>
    </id_info>
    <brief_title>Pressures During Prone Positions in Healthy Volunteers</brief_title>
    <acronym>HEALTHY-PRONE</acronym>
    <official_title>Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Régional d'Orléans</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Régional d'Orléans</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>
        Prone positioning (PP) reduces mortality in the most severe cases of acute respiratory&#xD;
        distress syndrome (ARDS) (GUERIN NEJM 2013). Despite the benefits of PP, this technique&#xD;
        presents adverse effects such as an increased risk of bedsores, linked to the duration, which&#xD;
        must be around 16 consecutive hours (SUD, ICM, 2010).&#xD;
  &#xD;
        There are 2 PP techniques:&#xD;
  &#xD;
          1. Positioning with arms alongside the body&#xD;
  &#xD;
          2. Swimmer's position At present, no study compares or has compared (medline source,&#xD;
             October 2022) prospectively, the impact of the type of position used during ventral&#xD;
             decubitus on mortality and the incidence of pressure sores, nor on secondary effects in&#xD;
             intensive care.&#xD;
  &#xD;
        Pressure transducers are available for instantaneous measurement of pressures between 2&#xD;
        interfaces. We have acquired a pressure-measuring device, a mattress topper which is attached&#xD;
        to the resuscitation mattress and which, connected to a PC, provides a live display of the&#xD;
        pressures between the patient and the mattress.&#xD;
  &#xD;
        We would like to use our device to measure pressures during these 2 PP in healthy volunteers,&#xD;
        which would enable us to obtain the world's first data on the real pressures generated during&#xD;
        PP.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Skin/Bed pressures</measure>
      <time_frame>5 minutes</time_frame>
      <description>Obtain pressure values for both prone position techniques on pressure sore risk zones (face/shoulders/hips/knees/feet)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Pressure Ulcer</condition>
    <arm_group>
      <arm_group_label>Swimmer Position</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Arms at side</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Prone Position</intervention_name>
      <description>All healthy volunteers will be positioned in prone position, on a bed equipped with a mapping pressure system.&#xD;
  The volunteers will spend 5 minutes in each of the positions corresponding to the study groups.</description>
      <arm_group_label>Arms at side</arm_group_label>
      <arm_group_label>Swimmer Position</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  Major volunteer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Volunteers with cervical mobility problems preventing them from rotating their head&#xD;
               90°&#xD;
  &#xD;
            -  Volunteers with scapulohumeral joint mobility problems preventing them from performing&#xD;
               90° elevation/abduction.&#xD;
  &#xD;
            -  Pregnant volunteer (confirmed by a blood sample test or a positive pregnancy test).&#xD;
  &#xD;
            -  Volunteer not affiliated to a French social security system&#xD;
  &#xD;
            -  Volunteer protected by law&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guillaume FOSSAT, Msc</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU ORLEANS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aurelie DESPUJOLS</last_name>
      <phone>0238744071</phone>
      <phone_ext>+33</phone_ext>
      <email>aurelie.despujols@chr-orleans.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centre Hospitalier Régional d'Orléans</name>
        <address>
          <city>Orléans</city>
          <state>Centre Val De Loire</state>
          <zip>45067</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Healthy Volunteer</keyword>
    <keyword>Pressure Mapping</keyword>
    <keyword>ARDS</keyword>
    <keyword>Prone Position</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pressure Ulcer</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06025370
  org study id: CHRO-2022-13
  nct id: NCT06025370
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Prone positioning (PP) reduces mortality in the most severe cases of acute respiratory
        distress syndrome (ARDS) (GUERIN NEJM 2013). Despite the benefits of PP, this technique
        presents adverse effects such as an increased risk of bedsores, linked to the duration, which
        must be around 16 consecutive hours (SUD, ICM, 2010).
  
        There are 2 PP techniques:
  
          1. Positioning with arms alongside the body
  
          2. Swimmer's position At present, no study compares or has compared (medline source,
             October 2022) prospectively, the impact of the type of position used during ventral
             decubitus on mortality and the incidence of pressure sores, nor on secondary effects in
             intensive care.
  
        Pressure transducers are available for instantaneous measurement of pressures between 2
        interfaces. We have acquired a pressure-measuring device, a mattress topper which is attached
        to the resuscitation mattress and which, connected to a PC, provides a live display of the
        pressures between the patient and the mattress.
  
        We would like to use our device to measure pressures during these 2 PP in healthy volunteers,
        which would enable us to obtain the world's first data on the real pressures generated during
        PP.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Skin/Bed pressures
  time frame: 5 minutes
  description: Obtain pressure values for both prone position techniques on pressure sore risk zones (face/shoulders/hips/knees/feet)
  arm group label: Swimmer Position
  arm group type: Experimental
  arm group label: Arms at side
  arm group type: Active Comparator
  intervention type: Other
  intervention name: Prone Position
  description: All healthy volunteers will be positioned in prone position, on a bed equipped with a mapping pressure system.
  The volunteers will spend 5 minutes in each of the positions corresponding to the study groups.
  arm group label: Arms at side
  arm group label: Swimmer Position
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Guillaume FOSSAT, Msc
  role: Principal Investigator
  affiliation: CHU ORLEANS
  last name: Aurelie DESPUJOLS
  phone: 0238744071
  phone ext: +33
  email: aurelie.despujols@chr-orleans.fr
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Pressure Ulcer
  sharing ipd: No