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/NCT06004466</url>
    </required_header>
    <id_info>
      <org_study_id>202203103DIND</org_study_id>
      <nct_id>NCT06004466</nct_id>
    </id_info>
    <brief_title>Noninvasive Internal Jugular Venous Oximetry</brief_title>
    <official_title>The Development of Novel Noninvasive Internal Jugular Venous Oximetry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study, we are developing a novel plethysmographic monitoring device which&#xD;
        incorporates several key techniques: inclusion of structural information (ultrasound image),&#xD;
        coupling with the estimation of local tissue optical parameters, consideration of the tissue&#xD;
        scattering absorption coefficient of each subject, to finally calculate the noninvasive&#xD;
        continuous internal jugular venous saturation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Central venous oxygen (ScvO2) is an important index for evaluating tissue perfusion in&#xD;
        clinical care. To obtain the ScvO2 value, blood analysis must be obtained through a central&#xD;
        venous catheter (CVC). Although CVC placement has a low incidence of complications, however,&#xD;
        detrimental complications such as pneumothorax, hemothorax, infection and arrhythmia, are&#xD;
        often fatal. In addition, continuous monitoring of ScvO2 often requires expensive equipment,&#xD;
        so usually clinical caregivers can only take blood tests at specific care intervals, and may&#xD;
        miss the opportunity to detect disease deterioration. In terms of anatomical structure and&#xD;
        physiology, the values of internal jugular blood oxygen (SijvO2) and ScvO2 should be very&#xD;
        close, and the evidence in the literature also points out that SijvO2 is not only highly&#xD;
        similar to ScvO2, but also related to changes in cerebral blood oxygen. The internal jugular&#xD;
        vein location is also an easier location for non-invasive continuous monitoring and thus it&#xD;
        is interested to develop the novel technique for noninvasive continuous SijvO2 monitoring.&#xD;
  &#xD;
        In this study, we are developing a novel plethysmographic monitoring device which&#xD;
        incorporates several key techniques: inclusion of structural information (ultrasound image),&#xD;
        coupling with the estimation of local tissue optical parameters, consideration of the tissue&#xD;
        scattering absorption coefficient of each subject, to finally calculate the noninvasive&#xD;
        continuous internal jugular venous saturation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Internal jugular venous saturation</measure>
      <time_frame>20 min</time_frame>
      <description>To validate the estimation of noninvasive internal jugular venous saturation and the real value by obtaing the internal jugular venous blood during central venous catheter placement</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Neoplasms</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adult cancer patients without organ dysfunction undergong planned central venous catheter&#xD;
          placement for cancer surgery or totally implantable venous access device placement for&#xD;
          future chemotherapy. During the central venous line placement, 3 ml blood sample from the&#xD;
          internal jugular vein is obtained for internal validation of internal jugular venous&#xD;
          saturation for our device.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing major cancer surgery that requires central venous catheter&#xD;
               placement&#xD;
  &#xD;
            -  Cancer patients undergoing totally implantable venous access device placement&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Susepct infectious symptoms and signs (eg. white blood cell count count &gt;10000 ; fever&#xD;
               &gt;38.3℃)&#xD;
  &#xD;
            -  impaired liver functions (aspartate aminotransferase&gt; 100 U/L); impaired renal&#xD;
               function (estimated glomerular filtration rate &lt;60 mL/min/1.73 m2)&#xD;
  &#xD;
            -  heart failure, with New York Heart Associatation class 2 or more&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chun-Yu Wu</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Taiwan University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chun-Yu Wu</last_name>
      <phone>886976653376</phone>
      <email>b001089018@tmu.edu.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <zip>100</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chun-Yu Wu</last_name>
        <phone>886976653376</phone>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06004466
  org study id: 202203103DIND
  nct id: NCT06004466
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this study, we are developing a novel plethysmographic monitoring device which
        incorporates several key techniques: inclusion of structural information (ultrasound image),
        coupling with the estimation of local tissue optical parameters, consideration of the tissue
        scattering absorption coefficient of each subject, to finally calculate the noninvasive
        continuous internal jugular venous saturation.
  Central venous oxygen (ScvO2) is an important index for evaluating tissue perfusion in
        clinical care. To obtain the ScvO2 value, blood analysis must be obtained through a central
        venous catheter (CVC). Although CVC placement has a low incidence of complications, however,
        detrimental complications such as pneumothorax, hemothorax, infection and arrhythmia, are
        often fatal. In addition, continuous monitoring of ScvO2 often requires expensive equipment,
        so usually clinical caregivers can only take blood tests at specific care intervals, and may
        miss the opportunity to detect disease deterioration. In terms of anatomical structure and
        physiology, the values of internal jugular blood oxygen (SijvO2) and ScvO2 should be very
        close, and the evidence in the literature also points out that SijvO2 is not only highly
        similar to ScvO2, but also related to changes in cerebral blood oxygen. The internal jugular
        vein location is also an easier location for non-invasive continuous monitoring and thus it
        is interested to develop the novel technique for noninvasive continuous SijvO2 monitoring.
  
        In this study, we are developing a novel plethysmographic monitoring device which
        incorporates several key techniques: inclusion of structural information (ultrasound image),
        coupling with the estimation of local tissue optical parameters, consideration of the tissue
        scattering absorption coefficient of each subject, to finally calculate the noninvasive
        continuous internal jugular venous saturation.
  observational model: Case-Only
  time perspective: Prospective
  measure: Internal jugular venous saturation
  time frame: 20 min
  description: To validate the estimation of noninvasive internal jugular venous saturation and the real value by obtaing the internal jugular venous blood during central venous catheter placement
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Chun-Yu Wu
  role: Principal Investigator
  affiliation: National Taiwan University Hospital
  last name: Chun-Yu Wu
  phone: 886976653376
  email: b001089018@tmu.edu.tw
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor