<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/NCT03280953</url>
  </required_header>
  <id_info>
    <org_study_id>837.004.16</org_study_id>
    <nct_id>NCT03280953</nct_id>
  </id_info>
  <brief_title>Assessing Fluid Responsiveness With PWTT</brief_title>
  <official_title>Finding the Cut-off Value of Pulse Wave Transit Time (PWTT) to Estimate the Fluid Responsibility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</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>
      Pulse wave Transit time (PWTT) is a parameter calculated from ECG and pulseoximeter. It is&#xD;
      supposed to help assessing the preload Status and guide intraoperative fluid therapy. This&#xD;
      Project aims to validate the benefit of PWTT assessment in an observational clinical fluid&#xD;
      study. In case of hypovolemia, patients will receive a fluid Bolus and hemodynamic data from&#xD;
      clinical Standard Monitoring, esophageal doppler and PWTT will be recorded before and after&#xD;
      the fluid Bolus. Receiver operating characteristic (ROC) curve will be used to determine the&#xD;
      validity of PWTT as indicator for fluid responsiveness and its cut off value.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PWTT is determined by measuring the beginning and the end of pulse wave duration and can be&#xD;
      calculated as the time interval from the ECG R-wave peak to the rise point of the pulse&#xD;
      oximeter wave.&#xD;
&#xD;
      it consists of two components: pre ejection period (PEP) and arterial pulse wave transit time&#xD;
      (a-PWTT). PEP is defined as the time from the ECG R wave to the rise point of the aortic root&#xD;
      pressure wave. a-PWTT is defined as the time from the rise point of the aortic pressure wave&#xD;
      to the rise point of the pulse oximeter wave. a-PWTT is the component which is directly&#xD;
      related to the velocity of the pulse wave. However noninvasively, we can measure only PWTT,&#xD;
      which also includes PEP. In general, PEP change over short periods of time is negligible in&#xD;
      most cases, so we can assume that PWTT corresponds to&#xD;
&#xD;
      a-PWTT. In studies using several studies using animals and healthy volunteers, PWTT showed&#xD;
      good correlation with stroke volume or systolic blood pressure. Also in experimental and&#xD;
      clinical setting, it is shown that PEP changes indicate change in preloads.&#xD;
&#xD;
      It is not known at this moment, which of the following factors to be considered in processing&#xD;
      raw data to acquire accurate PWTT value on predicting fluid responsiveness.&#xD;
&#xD;
        1. The beginning of pulse wave can be assessed by the appearance of either Q wave, which&#xD;
           represents the initial phase of depolarisation going through the interventricular septum&#xD;
           or R wave, which represents the ventricular depolarisation in ECG.&#xD;
&#xD;
        2. The end of pulse wave duration can be assessed by peripheral plethysmography mostly from&#xD;
           a finger tip but also from an ear lobe.&#xD;
&#xD;
        3. The pulse wave time can be simply measured as it is, but can also be adjusted by heart&#xD;
           rate using Bazett-Formula.&#xD;
&#xD;
        4. Not only the simple PWTT but also ventilatory induced fluctuation of PWTT (ΔPWTT) may be&#xD;
           used for predicting fluid responsiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2016</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>PWTT change before and after fluid bolus</measure>
    <time_frame>1 day</time_frame>
    <description>PWTT recorded before and 1 minute after fluid bolus of 7ml/kg intraoperatively. PWTT values will be calculated: defining PWTT start by either Q-wave or R-wave, defining PWTT end at arrival of the plethysmographic signal either at the finger tip or at the ear lobe, defining PWTT length by either simple measurement or adjusted by the Bazett-Formula. Additionally, as a dynamic parameter respiratory variation of PWTT (ΔPWTT) will be computed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate before and after fluid bolus</measure>
    <time_frame>1 day</time_frame>
    <description>Heart rate (in beats per minute), derived from intraoperative standard monitoring. This hemodynamic parameter will be measured before and 1min after fluid bolus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure before and after fluid bolus</measure>
    <time_frame>1 day</time_frame>
    <description>Systolic blood pressure/diastolic blood pressure/mean arterial pressure (in millimeters of mercury), derived from intraoperative standard monitoring. This hemodynamic parameter will be measured before and 1min after fluid bolus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flow Time corrected before and after fluid bolus</measure>
    <time_frame>1 day</time_frame>
    <description>Flow Time corrected (in milliseconds) measured by esophageal doppler. This hemodynamic parameter will be measured before and 1min after fluid bolus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke volume before and after fluid bolus</measure>
    <time_frame>1 day</time_frame>
    <description>Stroke volume (in milliliters per heartbeat) measured by esophageal doppler. This hemodynamic parameter will be measured before and 1min after fluid bolus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse Pressure Variation before and after fluid bolus</measure>
    <time_frame>1 day</time_frame>
    <description>Pulse Pressure Variation (as percentage) assessed using arterial pressure monitoring. This hemodynamic parameter will be measured before and 1min after fluid bolus.</description>
  </secondary_outcome>
  <enrollment type="Actual">38</enrollment>
  <condition>Fluid Therapy</condition>
  <condition>Monitoring, Intraoperative</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Assessing fluid responsiveness by PWTT value</intervention_name>
    <description>PWTT value will be analysed to find the cutoff values compared by esophageal doppler and pulse pressure variation.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are scheduled for elective open abdominal surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 - 80 years old&#xD;
&#xD;
          -  elective open abdominal surgery&#xD;
&#xD;
          -  clinical indication for direct arterial blood pressure Monitoring&#xD;
&#xD;
          -  supine Position intraoperatively&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 18 years, over 80 years old&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  no informed consent&#xD;
&#xD;
          -  systemic inflammatory response syndrome (SIRS) or Sepsis&#xD;
&#xD;
          -  Severe cardiac, coronary or vascular disease&#xD;
&#xD;
          -  Arrythmia&#xD;
&#xD;
          -  Cardiac valves anomaly&#xD;
&#xD;
          -  BMI &gt; 35&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status classification system: 4&#xD;
&#xD;
          -  Lung disease that excludes Ventilation with a tidal volume &gt;8ml/kg&#xD;
&#xD;
          -  esophageal pathology&#xD;
&#xD;
          -  planned prone position surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimiko Fukui-Dunkel, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center of Johannes Gutenberg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center of Johannes Gutenberg University</name>
      <address>
        <city>Mainz</city>
        <state>Rheinland-Pfalz</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Rhodes A, Cecconi M, Hamilton M, Poloniecki J, Woods J, Boyd O, Bennett D, Grounds RM. Goal-directed therapy in high-risk surgical patients: a 15-year follow-up study. Intensive Care Med. 2010 Aug;36(8):1327-32. doi: 10.1007/s00134-010-1869-6. Epub 2010 Apr 8.</citation>
    <PMID>20376431</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>Gunther Pestel MD, PhD</investigator_full_name>
    <investigator_title>Consultant of Anesthesiology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03280953
org study id: 837.004.16
nct id: NCT03280953
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pulse wave Transit time (PWTT) is a parameter calculated from ECG and pulseoximeter. It is
      supposed to help assessing the preload Status and guide intraoperative fluid therapy. This
      Project aims to validate the benefit of PWTT assessment in an observational clinical fluid
      study. In case of hypovolemia, patients will receive a fluid Bolus and hemodynamic data from
      clinical Standard Monitoring, esophageal doppler and PWTT will be recorded before and after
      the fluid Bolus. Receiver operating characteristic (ROC) curve will be used to determine the
      validity of PWTT as indicator for fluid responsiveness and its cut off value.
PWTT is determined by measuring the beginning and the end of pulse wave duration and can be
      calculated as the time interval from the ECG R-wave peak to the rise point of the pulse
      oximeter wave.

      it consists of two components: pre ejection period (PEP) and arterial pulse wave transit time
      (a-PWTT). PEP is defined as the time from the ECG R wave to the rise point of the aortic root
      pressure wave. a-PWTT is defined as the time from the rise point of the aortic pressure wave
      to the rise point of the pulse oximeter wave. a-PWTT is the component which is directly
      related to the velocity of the pulse wave. However noninvasively, we can measure only PWTT,
      which also includes PEP. In general, PEP change over short periods of time is negligible in
      most cases, so we can assume that PWTT corresponds to

      a-PWTT. In studies using several studies using animals and healthy volunteers, PWTT showed
      good correlation with stroke volume or systolic blood pressure. Also in experimental and
      clinical setting, it is shown that PEP changes indicate change in preloads.

      It is not known at this moment, which of the following factors to be considered in processing
      raw data to acquire accurate PWTT value on predicting fluid responsiveness.

        1. The beginning of pulse wave can be assessed by the appearance of either Q wave, which
           represents the initial phase of depolarisation going through the interventricular septum
           or R wave, which represents the ventricular depolarisation in ECG.

        2. The end of pulse wave duration can be assessed by peripheral plethysmography mostly from
           a finger tip but also from an ear lobe.

        3. The pulse wave time can be simply measured as it is, but can also be adjusted by heart
           rate using Bazett-Formula.

        4. Not only the simple PWTT but also ventilatory induced fluctuation of PWTT (ΔPWTT) may be
           used for predicting fluid responsiveness.
observational model: Case-Only
time perspective: Prospective
measure: PWTT change before and after fluid bolus
time frame: 1 day
description: PWTT recorded before and 1 minute after fluid bolus of 7ml/kg intraoperatively. PWTT values will be calculated: defining PWTT start by either Q-wave or R-wave, defining PWTT end at arrival of the plethysmographic signal either at the finger tip or at the ear lobe, defining PWTT length by either simple measurement or adjusted by the Bazett-Formula. Additionally, as a dynamic parameter respiratory variation of PWTT (ΔPWTT) will be computed.
measure: Heart rate before and after fluid bolus
time frame: 1 day
description: Heart rate (in beats per minute), derived from intraoperative standard monitoring. This hemodynamic parameter will be measured before and 1min after fluid bolus.
measure: Blood pressure before and after fluid bolus
time frame: 1 day
description: Systolic blood pressure/diastolic blood pressure/mean arterial pressure (in millimeters of mercury), derived from intraoperative standard monitoring. This hemodynamic parameter will be measured before and 1min after fluid bolus.
measure: Flow Time corrected before and after fluid bolus
time frame: 1 day
description: Flow Time corrected (in milliseconds) measured by esophageal doppler. This hemodynamic parameter will be measured before and 1min after fluid bolus.
measure: Stroke volume before and after fluid bolus
time frame: 1 day
description: Stroke volume (in milliliters per heartbeat) measured by esophageal doppler. This hemodynamic parameter will be measured before and 1min after fluid bolus.
measure: Pulse Pressure Variation before and after fluid bolus
time frame: 1 day
description: Pulse Pressure Variation (as percentage) assessed using arterial pressure monitoring. This hemodynamic parameter will be measured before and 1min after fluid bolus.
intervention type: Diagnostic Test
intervention name: Assessing fluid responsiveness by PWTT value
description: PWTT value will be analysed to find the cutoff values compared by esophageal doppler and pulse pressure variation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kimiko Fukui-Dunkel, M.D., Ph.D.
role: Principal Investigator
affiliation: University Medical Center of Johannes Gutenberg University
facility: 
country: Germany
citation: Rhodes A, Cecconi M, Hamilton M, Poloniecki J, Woods J, Boyd O, Bennett D, Grounds RM. Goal-directed therapy in high-risk surgical patients: a 15-year follow-up study. Intensive Care Med. 2010 Aug;36(8):1327-32. doi: 10.1007/s00134-010-1869-6. Epub 2010 Apr 8.
PMID: 20376431
responsible party type: Principal Investigator
investigator affiliation: Johannes Gutenberg University Mainz
investigator full name: Gunther Pestel MD, PhD
investigator title: Consultant of Anesthesiology
sharing ipd: No