<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/NCT04445909</url>
  </required_header>
  <id_info>
    <org_study_id>456499</org_study_id>
    <nct_id>NCT04445909</nct_id>
  </id_info>
  <brief_title>Validation of Continuous Transcutaneous Carbon Dioxide Monitoring in VA-ECMO Patients</brief_title>
  <official_title>Validation of Continuously Determined Transcutaneous Carbon Dioxide Partial Pressures in Patients Supported With Veno-arterial Extracorporeal Membrane Oxygenation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      Carbon dioxide in patients on veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is&#xD;
      eliminated via respirator as well as via the oxygenator's membrane of the ECMO machine.&#xD;
      Consequently, monitoring of end-tidal carbon dioxide tensions is limited, which can result in&#xD;
      marked swings towards non-physiological values. Hyper- and hypocapnia, however, can have&#xD;
      detrimental effects on organ perfusion in a great number of patients supported with VA-ECMO.&#xD;
      Continuous, rapidly applicable monitoring of reliable carbon dioxide measures would therefore&#xD;
      be extremely helpful to prevent harmful deviations from the norm. The investigators therefore&#xD;
      try to assess the accuracy and the precision of continuously measured non-invasive&#xD;
      transcutaneous carbon dioxide partial pressures when compared with tensions determined by&#xD;
      blood gas analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After documenting the characteristics of participants, cannulation site, and the cause for&#xD;
      ECMO support, transcutaneous, arterial, venous, as well as end-tidal carbon dioxide partial&#xD;
      pressure values are measured simultaneously at steady state conditions and compared with each&#xD;
      other at various time points over a four-hour observation period. In addition, oxygen&#xD;
      tensions are registered transcutaneously and in arterial and venous blood while respirator&#xD;
      settings, sweep gas flow, ECMO flow, body temperature, volume status, and the dosage of&#xD;
      vasopressors are also being recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 18, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Agreement between transcutaneous carbon dioxide partial pressure measurement and arterial carbon dioxide partial pressures in VA-ECMO patients.</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>Bland Altman plot, Pearson correlation, Concordance analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reaction time from attachment of sensor to first reliable reading and its modifiers</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>Descriptive statistics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Agreement between transcutaneous oxygen partial pressure measurement and arterial oxygen partial pressures in VA-ECMO patients.</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>Bland Altman plot, Pearson correlation, Concordance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between transcutaneous carbon dioxide partial pressure level and brain saturation</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>Pearson correlation, Concordance analysis</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Carbon Dioxide</condition>
  <arm_group>
    <arm_group_label>VA-ECMO patients</arm_group_label>
    <description>VA-ECMO support because of low cardiac output.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VA-ECMO</intervention_name>
    <description>Deployment of extracorporeal membrane oxygenation cardiac assist device.</description>
    <arm_group_label>VA-ECMO patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with low cardiac output after ECMO deployment in tertiary care center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Low cardiac output requiring VA-ECMO support.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Dworschak, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martin Dworschak, MD, MBA</last_name>
    <phone>+43-1-40400</phone>
    <phone_ext>41090</phone_ext>
    <email>martin.dworschak@meduniwien.ac.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Dworschak, MD, MBA</last_name>
      <phone>+43-1-40400</phone>
      <phone_ext>41090</phone_ext>
      <email>martin.dworschak@meduniwien.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Martin Bernardi, MD</last_name>
      <phone>+43-1-40400</phone>
      <phone_ext>64100</phone_ext>
      <email>martin.bernardi@meduniwien.ac.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Dr. Martin Dworschak</investigator_full_name>
    <investigator_title>Assoc. Prof. of Anesthesia and Intensive Care Medicine</investigator_title>
  </responsible_party>
  <keyword>ECMO</keyword>
  <keyword>Carbon dioxide elimination</keyword>
  <keyword>Organ perfusion</keyword>
  <keyword>Low cardiac output</keyword>
  <keyword>Monitoring</keyword>
  <keyword>Critical Care</keyword>
  <!-- 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/NCT04445909
org study id: 456499
nct id: NCT04445909
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Carbon dioxide in patients on veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is
      eliminated via respirator as well as via the oxygenator's membrane of the ECMO machine.
      Consequently, monitoring of end-tidal carbon dioxide tensions is limited, which can result in
      marked swings towards non-physiological values. Hyper- and hypocapnia, however, can have
      detrimental effects on organ perfusion in a great number of patients supported with VA-ECMO.
      Continuous, rapidly applicable monitoring of reliable carbon dioxide measures would therefore
      be extremely helpful to prevent harmful deviations from the norm. The investigators therefore
      try to assess the accuracy and the precision of continuously measured non-invasive
      transcutaneous carbon dioxide partial pressures when compared with tensions determined by
      blood gas analysis.
After documenting the characteristics of participants, cannulation site, and the cause for
      ECMO support, transcutaneous, arterial, venous, as well as end-tidal carbon dioxide partial
      pressure values are measured simultaneously at steady state conditions and compared with each
      other at various time points over a four-hour observation period. In addition, oxygen
      tensions are registered transcutaneously and in arterial and venous blood while respirator
      settings, sweep gas flow, ECMO flow, body temperature, volume status, and the dosage of
      vasopressors are also being recorded.
observational model: Cohort
time perspective: Cross-Sectional
measure: Agreement between transcutaneous carbon dioxide partial pressure measurement and arterial carbon dioxide partial pressures in VA-ECMO patients.
time frame: Through study completion, an average of 2 years
description: Bland Altman plot, Pearson correlation, Concordance analysis
measure: Reaction time from attachment of sensor to first reliable reading and its modifiers
time frame: Through study completion, an average of 2 years
description: Descriptive statistics
measure: Agreement between transcutaneous oxygen partial pressure measurement and arterial oxygen partial pressures in VA-ECMO patients.
time frame: Through study completion, an average of 2 years
description: Bland Altman plot, Pearson correlation, Concordance analysis
measure: Correlation between transcutaneous carbon dioxide partial pressure level and brain saturation
time frame: Through study completion, an average of 2 years
description: Pearson correlation, Concordance analysis
arm group label: VA-ECMO patients
description: VA-ECMO support because of low cardiac output.
intervention type: Device
intervention name: VA-ECMO
description: Deployment of extracorporeal membrane oxygenation cardiac assist device.
arm group label: VA-ECMO patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Martin Dworschak, MD, MBA
role: Principal Investigator
affiliation: Medical University of Vienna
last name: Martin Dworschak, MD, MBA
phone: +43-1-40400
phone ext: 41090
email: martin.dworschak@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Dr. Martin Dworschak
investigator title: Assoc. Prof. of Anesthesia and Intensive Care Medicine