<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/NCT01714258</url>
  </required_header>
  <id_info>
    <org_study_id>CaraMat</org_study_id>
    <nct_id>NCT01714258</nct_id>
  </id_info>
  <brief_title>A Non Invasive Estimation of Cardiac Output in Mechanically Ventilated Patients</brief_title>
  <official_title>A Non Invasive Estimation of Cardiac Output in Mechanically Ventilated Patients: a Prolonged Expiration Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Campus Bio-Medico University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Campus Bio-Medico University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The two gold standard for cardiac output (CO) measurements, i.e., the Fick method and&#xD;
      pulmonary artery thermodilution , are both invasive methods, requiring the use of central&#xD;
      venous catheter and Swan-Ganz catheter, respectively.&#xD;
&#xD;
      With the aim to reduce the risks for the patient, a big research effort has been made to&#xD;
      investigate minimally invasive or non-invasive methods. Investigators sought to evaluate the&#xD;
      effectiveness of a non invasive method to estimate CO in mechanically ventilated patients.The&#xD;
      method is based on prolonged expiration, and relies on measurement of gas concentrations and&#xD;
      flow rate. Investigators designed, realized, and characterized a system to induce passive&#xD;
      prolonged expirations when connected to the patient circuit.&#xD;
&#xD;
      CO is then calculated using an algorithm based a modified version of the Fick equation and&#xD;
      the results are compared with the ones obtained by thermodilution.&#xD;
&#xD;
      Several advantages can be introduced by the prolonged expiration technique: non-invasive&#xD;
      measurement, easy implementation, independency from operator ability among others.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective trial was designed to assess the performance of a non invasive method to&#xD;
      estimate cardiac output in mechanically ventilated cardiac surgery patients and its outcome&#xD;
      is compared to the values obtained from the invasive measurement system based on&#xD;
      thermodilution. The pulmonary blood flow (PBF), which is the volume of blood that actively&#xD;
      participates in the gas exchange per unit of time, is the directly estimated variable that&#xD;
      this technique employ to calculate cardiac output. The method investigators studied is&#xD;
      theoretically based on the application of an algorithm which derives from a modified version&#xD;
      of the Fick equation in two different phases; the former involves measurements during the&#xD;
      steady state, whilst the second starts when a sudden perturbation into the carbon dioxide&#xD;
      (CO2) elimination process is introduced. The algorithms investigated in this work requires&#xD;
      the analysis of the expired gas content during both normal breathing and prolonged&#xD;
      expiration, providing a non-invasive estimation of the artero-venous content of CO2, and&#xD;
      consequently allows the calculation of PBF according to the Fick method. At this purpose, a&#xD;
      metabolic monitor was used; it sampled gas from the &quot;Y&quot; piece of the mechanical ventilator's&#xD;
      breathing circuit through a suction pump. In order to obtain the prolonged expiration, a&#xD;
      pneumatic system, with an ad hoc designed orifice resistance (5 cmH2O•L-1•min),has been made&#xD;
      and experimentally characterized to adapt the breathing circuit to this application.&#xD;
      Experimental data of CO2 and O2 concentrations were recorded and processed after the&#xD;
      measurement session thanks to an ad hoc developed LabView application. This application&#xD;
      performs the following tasks: it converts the gas fractions into partial pressures, segments&#xD;
      the trends of partial pressures, executes the data-reduction and, after obtaining the values&#xD;
      of venous carbon dioxide tension (PvCO2) and arterial carbon dioxide tension (PaCO2)&#xD;
      obtained, it calculates the CO value using the above mentioned algorithms.&#xD;
&#xD;
      The values calculated with non invasive method showed good agreement with ones obtained by&#xD;
      thermodilution and a precision comparable to those of other minimally invasive techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A non invasive method to estimate cardiac output in mechanically ventilated surgery based on prolonged expiration and its outcome is compared to the values obtained from the invasive measurement system based on thermodilution.</measure>
    <time_frame>within the first day after surgery</time_frame>
    <description>To obtain cardiac output for each patient,throughout a period of about 45 min, thermodilution was executed 10 times, and prolonged expiration 20 times.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Non Invasive Estimation of Cardiac Output</condition>
  <arm_group>
    <arm_group_label>non invasive cardiac output measure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>non invasive cardiac output estimation based on passive induced prolonged expiration in mechanically ventilated patients 20 times, throughout a period of about 45 min</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cardiac output measurement</intervention_name>
    <description>non invasive cardiac output estimation based on passive induced prolonged expiration in mechanically ventilated patients</description>
    <arm_group_label>non invasive cardiac output measure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postoperative cardiac surgery patients mechanically ventilated after surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who were hemodynamically unstable requiring high doses of vasoactive&#xD;
             medications, fluids or colloidal solutions to maintain their pressure&#xD;
&#xD;
          -  Patients who require inspired oxygen concentration higher than 60%.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>massimiliano carassiti, prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Campus Bio-Medico University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Campus Biomedico</name>
      <address>
        <city>Rome</city>
        <zip>000128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Cecchini S, Schena E, Notaro M, Carassiti M, Silvestri S. Non-invasive estimation of cardiac output in mechanically ventilated patients: a prolonged expiration method. Ann Biomed Eng. 2012 Aug;40(8):1777-89. doi: 10.1007/s10439-012-0534-3. Epub 2012 Feb 24.</citation>
    <PMID>22361831</PMID>
  </results_reference>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>December 5, 2012</last_update_submitted>
  <last_update_submitted_qc>December 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Campus Bio-Medico University</investigator_affiliation>
    <investigator_full_name>Massimiliano Carassiti</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>cardiac output</keyword>
  <keyword>fick method</keyword>
  <keyword>thermodilution</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/NCT01714258
org study id: CaraMat
nct id: NCT01714258
lead sponsor: 
has dmc: Yes
The two gold standard for cardiac output (CO) measurements, i.e., the Fick method and
      pulmonary artery thermodilution , are both invasive methods, requiring the use of central
      venous catheter and Swan-Ganz catheter, respectively.

      With the aim to reduce the risks for the patient, a big research effort has been made to
      investigate minimally invasive or non-invasive methods. Investigators sought to evaluate the
      effectiveness of a non invasive method to estimate CO in mechanically ventilated patients.The
      method is based on prolonged expiration, and relies on measurement of gas concentrations and
      flow rate. Investigators designed, realized, and characterized a system to induce passive
      prolonged expirations when connected to the patient circuit.

      CO is then calculated using an algorithm based a modified version of the Fick equation and
      the results are compared with the ones obtained by thermodilution.

      Several advantages can be introduced by the prolonged expiration technique: non-invasive
      measurement, easy implementation, independency from operator ability among others.
This prospective trial was designed to assess the performance of a non invasive method to
      estimate cardiac output in mechanically ventilated cardiac surgery patients and its outcome
      is compared to the values obtained from the invasive measurement system based on
      thermodilution. The pulmonary blood flow (PBF), which is the volume of blood that actively
      participates in the gas exchange per unit of time, is the directly estimated variable that
      this technique employ to calculate cardiac output. The method investigators studied is
      theoretically based on the application of an algorithm which derives from a modified version
      of the Fick equation in two different phases; the former involves measurements during the
      steady state, whilst the second starts when a sudden perturbation into the carbon dioxide
      (CO2) elimination process is introduced. The algorithms investigated in this work requires
      the analysis of the expired gas content during both normal breathing and prolonged
      expiration, providing a non-invasive estimation of the artero-venous content of CO2, and
      consequently allows the calculation of PBF according to the Fick method. At this purpose, a
      metabolic monitor was used; it sampled gas from the "Y" piece of the mechanical ventilator's
      breathing circuit through a suction pump. In order to obtain the prolonged expiration, a
      pneumatic system, with an ad hoc designed orifice resistance (5 cmH2O•L-1•min),has been made
      and experimentally characterized to adapt the breathing circuit to this application.
      Experimental data of CO2 and O2 concentrations were recorded and processed after the
      measurement session thanks to an ad hoc developed LabView application. This application
      performs the following tasks: it converts the gas fractions into partial pressures, segments
      the trends of partial pressures, executes the data-reduction and, after obtaining the values
      of venous carbon dioxide tension (PvCO2) and arterial carbon dioxide tension (PaCO2)
      obtained, it calculates the CO value using the above mentioned algorithms.

      The values calculated with non invasive method showed good agreement with ones obtained by
      thermodilution and a precision comparable to those of other minimally invasive techniques.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: A non invasive method to estimate cardiac output in mechanically ventilated surgery based on prolonged expiration and its outcome is compared to the values obtained from the invasive measurement system based on thermodilution.
time frame: within the first day after surgery
description: To obtain cardiac output for each patient,throughout a period of about 45 min, thermodilution was executed 10 times, and prolonged expiration 20 times.
arm group label: non invasive cardiac output measure
arm group type: Experimental
description: non invasive cardiac output estimation based on passive induced prolonged expiration in mechanically ventilated patients 20 times, throughout a period of about 45 min
intervention type: Procedure
intervention name: cardiac output measurement
description: non invasive cardiac output estimation based on passive induced prolonged expiration in mechanically ventilated patients
arm group label: non invasive cardiac output measure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: massimiliano carassiti, prof
role: Principal Investigator
affiliation: Campus Bio-Medico University
facility: 
country: Italy
citation: Cecchini S, Schena E, Notaro M, Carassiti M, Silvestri S. Non-invasive estimation of cardiac output in mechanically ventilated patients: a prolonged expiration method. Ann Biomed Eng. 2012 Aug;40(8):1777-89. doi: 10.1007/s10439-012-0534-3. Epub 2012 Feb 24.
PMID: 22361831
responsible party type: Principal Investigator
investigator affiliation: Campus Bio-Medico University
investigator full name: Massimiliano Carassiti
investigator title: professor