<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/NCT03241069</url>
  </required_header>
  <id_info>
    <org_study_id>DYVIC</org_study_id>
    <nct_id>NCT03241069</nct_id>
  </id_info>
  <brief_title>Dynamic Variation of Impedance Cardiography(DYVIC) as a Diagnostic Tool of Acute Heart Failure (AHF)</brief_title>
  <acronym>DYVIC</acronym>
  <official_title>Dynamic Variation of Impedance Cardiography (ICG) a Diagnostic Tool of Acute Heart Failure (AHF) in Emergency Department (ED) Patients Admitted for Acute Dyspnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Monastir</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Monastir</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Dynamic variations of bio-impedance measured cardiac output using non pharmacologic&#xD;
      intervention (sitting position, passive leg rising and valsalva maneuver) could be used to&#xD;
      detect acute heart failure in patients admitted to the ED for dyspnea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute heart failure (AHF) is a frequent condition in emergency basis and is responsible of a&#xD;
      big number of admissions, complications, and deaths.&#xD;
&#xD;
      despite advances in diagnostic techniques, AHF diagnosis still difficult and cost not&#xD;
      effective.&#xD;
&#xD;
      Measurement of cardiac output (CO) is used as a way to evaluate global cardiac function and&#xD;
      changes in CO may be used to identify a change in the hemodynamic status of a patient.&#xD;
&#xD;
      the gold standard of measuring CO is thermodilution catheterization, however this is an&#xD;
      invasive technique that poses a risk to the patient.&#xD;
&#xD;
      Impedance cardiography (ICG) is a noninvasive method for measuring CO. it is performed by&#xD;
      applying small electrical current to the chest, and through electrodes placed on the neck and&#xD;
      sides.&#xD;
&#xD;
      the pulsatile flow of blood causes fluctuations in the current, and the device calculates CO&#xD;
      from the impedance waveform.&#xD;
&#xD;
      In practice, the investigators connect the device &quot;BIOPAC&quot; by using four electrodes which the&#xD;
      investigators place on the base of the neck (posterior face) and on the base of the thorax&#xD;
      (posterior face).&#xD;
&#xD;
      The ECG recording is taken simultaneously with two other electrodes placed at the right upper&#xD;
      limb and left lower limb.&#xD;
&#xD;
      In addition to detecting the electric current and the ECG, heart sounds are recorded using a&#xD;
      sensor that is placed at the mitral site.&#xD;
&#xD;
      The various curves are displayed simultaneously and stored for analysis. Subjects were first&#xD;
      placed in the semi sitting position 30°, and after 5 minutes had cardiac output measurements&#xD;
      performed. (CO1)&#xD;
&#xD;
      A second cardiac output measurement was performed after 5 min of seated position. (C02)&#xD;
&#xD;
      Patients were then placed in the initial position, and after an additional 5 minutes had&#xD;
      cardiac output measurements performed. (CO1')&#xD;
&#xD;
      A third set of measurement was obtained during 45° passive leg raising at 1 to 2&#xD;
      minutes.(CO3)&#xD;
&#xD;
      Patients were then placed in the initial position, and after an additional 5 minutes had&#xD;
      cardiac output measurements performed. (CO1'')&#xD;
&#xD;
      During a Valsalva maneuver the investigators took the fourth cardiac output measurement.&#xD;
      (CO4)&#xD;
&#xD;
      Patients were then placed in the initial position, and after an additional 5 minutes had&#xD;
      cardiac output measurements performed. (CO1''')&#xD;
&#xD;
      Dynamic variations on bio-impedance measured CO using non pharmacologic intervention (sitting&#xD;
      position, passive leg rising and Valsalva maneuver) could be used to detect AHF in patients&#xD;
      admitted to the ED for dyspnea.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac output rate measured by ICG before and during maneuvers in acute dyspneic patients between the AHF and non AHF groups</measure>
    <time_frame>12 hours</time_frame>
    <description>The diagnostic performance of each maneuver is evaluated by calculating the CO in ml/min by bio-impedance technique and compare the values between patients with and without AHF and between baseline.&#xD;
The diagnosis of AHF is based on clinical, biological (BNP levels), radiological (chest X-ray) and cardiac ultrasound data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>In hospital death</measure>
    <time_frame>up to 10 days</time_frame>
    <description>survivor or ,ot</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">290</enrollment>
  <condition>Acute Heart Failure</condition>
  <arm_group>
    <arm_group_label>patients with acute dyspnea</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients presenting to the emergency department with acute onset dyspnea are assessed for acute heart failure using the bio impedance technology (BIOPAC system) to measure the cardiac output in different clinical situations.&#xD;
FIRST: the cardiac output (CO) is measured at the reference position. Inbetween each step the patient was put in the reference position during 5 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the sitting position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the patient is put at the sitting position and we measure the cardiac output by BIOPAC system (patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured 5 minutes later)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>a passive leg rising maneuver</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>we make a passive leg rising and we measure the cardiac output by BIOPAC system (45 degree passive leg rising was done for 1 to 2 minutes and CO was measured during the maneuver 5minutes later.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Valsalva maneuver</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the patient was asked to perform the Valsalva maneuver and we measure the cardiac output by BIOPAC system(patients are asked to perform the Valsalva maneuver by executing a forced blow into a manometer for 30 seconds and the CO is calculated during this test.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Reference position</intervention_name>
    <description>patient is put in a 30 degree supine position during 5 minutes</description>
    <arm_group_label>Valsalva maneuver</arm_group_label>
    <arm_group_label>a passive leg rising maneuver</arm_group_label>
    <arm_group_label>patients with acute dyspnea</arm_group_label>
    <arm_group_label>the sitting position</arm_group_label>
    <other_name>baseline position</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sitting position</intervention_name>
    <description>patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured</description>
    <arm_group_label>Valsalva maneuver</arm_group_label>
    <arm_group_label>a passive leg rising maneuver</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Valsalva maneuver</intervention_name>
    <description>patients are asked to perform the Valsalva maneuver by executing a forced blow into a manometer for 30 seconds and the CO is calculated during this test.</description>
    <arm_group_label>a passive leg rising maneuver</arm_group_label>
    <arm_group_label>the sitting position</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>a passive leg rising maneuver</intervention_name>
    <description>we make a passive leg rising and we measure the cardiac output by BIOPAC system (45 degree passive leg rising was done for 1 to 2 minutes and CO was measured during the maneuver.)</description>
    <arm_group_label>Valsalva maneuver</arm_group_label>
    <arm_group_label>the sitting position</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 year old or above&#xD;
&#xD;
          -  non traumatic acute dyspnea&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 years,&#xD;
&#xD;
          -  cardio respiratory arrest,&#xD;
&#xD;
          -  coma,&#xD;
&#xD;
          -  shock,&#xD;
&#xD;
          -  need for inotropic or vasoactive drugs,&#xD;
&#xD;
          -  mechanical ventilation,&#xD;
&#xD;
          -  severe and sustained rhythm disorders,&#xD;
&#xD;
          -  severe mitral valve disease,&#xD;
&#xD;
          -  severe pulmonary arterial hypertension&#xD;
&#xD;
          -  renal insufficiency with creatinine&gt;150 μmol/l.&#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>Nouira Samir, Profesor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University hospital of Monastir</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency Department</name>
      <address>
        <city>Monastir</city>
        <zip>5000</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <link>
    <url>http://www.urgencemonastir.com</url>
    <description>official department website</description>
  </link>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 7, 2013</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>July 25, 2021</last_update_submitted>
  <last_update_submitted_qc>July 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Monastir</investigator_affiliation>
    <investigator_full_name>Pr. Semir Nouira</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>bio-impedance</keyword>
  <keyword>BIOPAC system</keyword>
  <keyword>dyspnea</keyword>
  <keyword>acute heart failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03241069
org study id: DYVIC
nct id: NCT03241069
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Dynamic variations of bio-impedance measured cardiac output using non pharmacologic
      intervention (sitting position, passive leg rising and valsalva maneuver) could be used to
      detect acute heart failure in patients admitted to the ED for dyspnea.
Acute heart failure (AHF) is a frequent condition in emergency basis and is responsible of a
      big number of admissions, complications, and deaths.

      despite advances in diagnostic techniques, AHF diagnosis still difficult and cost not
      effective.

      Measurement of cardiac output (CO) is used as a way to evaluate global cardiac function and
      changes in CO may be used to identify a change in the hemodynamic status of a patient.

      the gold standard of measuring CO is thermodilution catheterization, however this is an
      invasive technique that poses a risk to the patient.

      Impedance cardiography (ICG) is a noninvasive method for measuring CO. it is performed by
      applying small electrical current to the chest, and through electrodes placed on the neck and
      sides.

      the pulsatile flow of blood causes fluctuations in the current, and the device calculates CO
      from the impedance waveform.

      In practice, the investigators connect the device "BIOPAC" by using four electrodes which the
      investigators place on the base of the neck (posterior face) and on the base of the thorax
      (posterior face).

      The ECG recording is taken simultaneously with two other electrodes placed at the right upper
      limb and left lower limb.

      In addition to detecting the electric current and the ECG, heart sounds are recorded using a
      sensor that is placed at the mitral site.

      The various curves are displayed simultaneously and stored for analysis. Subjects were first
      placed in the semi sitting position 30°, and after 5 minutes had cardiac output measurements
      performed. (CO1)

      A second cardiac output measurement was performed after 5 min of seated position. (C02)

      Patients were then placed in the initial position, and after an additional 5 minutes had
      cardiac output measurements performed. (CO1')

      A third set of measurement was obtained during 45° passive leg raising at 1 to 2
      minutes.(CO3)

      Patients were then placed in the initial position, and after an additional 5 minutes had
      cardiac output measurements performed. (CO1'')

      During a Valsalva maneuver the investigators took the fourth cardiac output measurement.
      (CO4)

      Patients were then placed in the initial position, and after an additional 5 minutes had
      cardiac output measurements performed. (CO1''')

      Dynamic variations on bio-impedance measured CO using non pharmacologic intervention (sitting
      position, passive leg rising and Valsalva maneuver) could be used to detect AHF in patients
      admitted to the ED for dyspnea.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Care Provider, Outcomes Assessor)
measure: Cardiac output rate measured by ICG before and during maneuvers in acute dyspneic patients between the AHF and non AHF groups
time frame: 12 hours
description: The diagnostic performance of each maneuver is evaluated by calculating the CO in ml/min by bio-impedance technique and compare the values between patients with and without AHF and between baseline.
The diagnosis of AHF is based on clinical, biological (BNP levels), radiological (chest X-ray) and cardiac ultrasound data.
measure: In hospital death
time frame: up to 10 days
description: survivor or ,ot
arm group label: patients with acute dyspnea
arm group type: Experimental
description: patients presenting to the emergency department with acute onset dyspnea are assessed for acute heart failure using the bio impedance technology (BIOPAC system) to measure the cardiac output in different clinical situations.
FIRST: the cardiac output (CO) is measured at the reference position. Inbetween each step the patient was put in the reference position during 5 minutes.
arm group label: the sitting position
arm group type: Experimental
description: the patient is put at the sitting position and we measure the cardiac output by BIOPAC system (patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured 5 minutes later)
arm group label: a passive leg rising maneuver
arm group type: Experimental
description: we make a passive leg rising and we measure the cardiac output by BIOPAC system (45 degree passive leg rising was done for 1 to 2 minutes and CO was measured during the maneuver 5minutes later.)
arm group label: Valsalva maneuver
arm group type: Experimental
description: the patient was asked to perform the Valsalva maneuver and we measure the cardiac output by BIOPAC system(patients are asked to perform the Valsalva maneuver by executing a forced blow into a manometer for 30 seconds and the CO is calculated during this test.)
intervention type: Other
intervention name: Reference position
description: patient is put in a 30 degree supine position during 5 minutes
arm group label: Valsalva maneuver
arm group label: a passive leg rising maneuver
arm group label: patients with acute dyspnea
arm group label: the sitting position
other name: baseline position
intervention type: Other
intervention name: sitting position
description: patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured
arm group label: Valsalva maneuver
arm group label: a passive leg rising maneuver
intervention type: Other
intervention name: Valsalva maneuver
description: patients are asked to perform the Valsalva maneuver by executing a forced blow into a manometer for 30 seconds and the CO is calculated during this test.
arm group label: a passive leg rising maneuver
arm group label: the sitting position
intervention type: Other
intervention name: a passive leg rising maneuver
description: we make a passive leg rising and we measure the cardiac output by BIOPAC system (45 degree passive leg rising was done for 1 to 2 minutes and CO was measured during the maneuver.)
arm group label: Valsalva maneuver
arm group label: the sitting position
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nouira Samir, Profesor
role: Principal Investigator
affiliation: University hospital of Monastir
facility: 
country: Tunisia
url: http://www.urgencemonastir.com
description: official department website
responsible party type: Principal Investigator
investigator affiliation: University of Monastir
investigator full name: Pr. Semir Nouira
investigator title: Professor
mesh term: Heart Failure
sharing ipd: Undecided