<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/NCT04443491</url>
  </required_header>
  <id_info>
    <org_study_id>PPL project</org_study_id>
    <nct_id>NCT04443491</nct_id>
  </id_info>
  <brief_title>Comparison of Esophageal and Central Venous Pressure for Estimating Transpulmonary Pressure Changes</brief_title>
  <acronym>PPLproject</acronym>
  <official_title>Estimating the Transpulmonary Pressure From the Central Venous Pressure in Mechanically Ventilated Patients With Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Siena</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Siena</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>
      Central venous pressure (CVP) is characterized by a low-frequency pleural-dependent as well&#xD;
      as a high-frequency cardiac pulsatile component. The aim of the study is to compare the&#xD;
      low-frequency component of CVP with the esophageal pressure (Pes), as surrogate of pleural&#xD;
      pressure, to estimate trans-pulmonary pressure (PL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will enroll mechanically ventilated patients admitted to the intensive care&#xD;
      unit with the diagnosis of respiratory failure monitored with a dedicated nasogastric&#xD;
      catheter and a central venous catheter for measuring Pes and CVP, respectively.&#xD;
      Electrocardiogram trace, Pes, CVP and airway pressure (Paw) will be recorded at the end of&#xD;
      inspiratory and expiratory pauses. The CVP waveforms will be analyzed off-line using a&#xD;
      dedicated low-pass digital filter to obtain the low-frequency component of CVP (filtered CVP,&#xD;
      fCVP). Paw, Pes and fCVP will be used to calculate PL using transpulmonary driving pressure&#xD;
      formula (PL-Pes and PL-fCVP, respectively). The PL values obtained with fCVP and Pes will be&#xD;
      compared to assess the correlation of the two methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">March 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Transpulmonary pressure</measure>
    <time_frame>Within 72 hours from the starting of mechanical ventilation</time_frame>
    <description>Correlation and agreement between the transpulmonary pressure obtained from esophageal balloon catheter and central venous catheter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transpulmonary pressure in subgroups of patients</measure>
    <time_frame>Within 72 hours from the starting of mechanical ventilation</time_frame>
    <description>Agreement between trans pulmonary pressure obtained with the two methods in subgroup of patients such as those with acute respiratory distress syndrome or obesity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transpulmonary pressure in patients at risk for ventilator-induced-lung-injury</measure>
    <time_frame>Within 72 hours from the starting of mechanical ventilation</time_frame>
    <description>Comparison of the transpulmonary pressure obtained with the two methods in patients at risk for ventilator-induced-lung-injury</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Mechanical Ventilation</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to ICU treated with mechanical ventilation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients receiving invasive mechanical ventilation&#xD;
&#xD;
          -  diagnosis of acute respiratory failure (defined as the ratio of partial oxygen&#xD;
             pressure and fraction of inspired oxygen below 200 mmHg)&#xD;
&#xD;
          -  esophageal balloon catheter&#xD;
&#xD;
          -  central venous catheter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 18 years old&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  Esophageal diseases (varices, stenosis..)&#xD;
&#xD;
          -  Refusal of the patient&#xD;
&#xD;
          -  evidence of active air leak from the lung (pneumothorax, pneumomediastinum, existing&#xD;
             chest tube....)&#xD;
&#xD;
          -  history of lung/abdominal surgery&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  severe coagulopathy&#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>Federico Franchi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Siena, Depatment of Medical Biotechnology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Senese</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 21, 2020</last_update_submitted>
  <last_update_submitted_qc>June 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Siena</investigator_affiliation>
    <investigator_full_name>Federico Franchi</investigator_full_name>
    <investigator_title>Principal Investigator; Associate professor of Anesthesiology; Anesthesia and Intensive Care Unit, Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy</investigator_title>
  </responsible_party>
  <keyword>esophageal pressure</keyword>
  <keyword>transpulmonary pressure</keyword>
  <keyword>central venous pressure</keyword>
  <keyword>acute respiratory failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
  </condition_browse>
  <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/NCT04443491
org study id: PPL project
nct id: NCT04443491
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Central venous pressure (CVP) is characterized by a low-frequency pleural-dependent as well
      as a high-frequency cardiac pulsatile component. The aim of the study is to compare the
      low-frequency component of CVP with the esophageal pressure (Pes), as surrogate of pleural
      pressure, to estimate trans-pulmonary pressure (PL).
The investigators will enroll mechanically ventilated patients admitted to the intensive care
      unit with the diagnosis of respiratory failure monitored with a dedicated nasogastric
      catheter and a central venous catheter for measuring Pes and CVP, respectively.
      Electrocardiogram trace, Pes, CVP and airway pressure (Paw) will be recorded at the end of
      inspiratory and expiratory pauses. The CVP waveforms will be analyzed off-line using a
      dedicated low-pass digital filter to obtain the low-frequency component of CVP (filtered CVP,
      fCVP). Paw, Pes and fCVP will be used to calculate PL using transpulmonary driving pressure
      formula (PL-Pes and PL-fCVP, respectively). The PL values obtained with fCVP and Pes will be
      compared to assess the correlation of the two methods.
observational model: Cohort
time perspective: Prospective
measure: Transpulmonary pressure
time frame: Within 72 hours from the starting of mechanical ventilation
description: Correlation and agreement between the transpulmonary pressure obtained from esophageal balloon catheter and central venous catheter
measure: Transpulmonary pressure in subgroups of patients
time frame: Within 72 hours from the starting of mechanical ventilation
description: Agreement between trans pulmonary pressure obtained with the two methods in subgroup of patients such as those with acute respiratory distress syndrome or obesity
measure: Transpulmonary pressure in patients at risk for ventilator-induced-lung-injury
time frame: Within 72 hours from the starting of mechanical ventilation
description: Comparison of the transpulmonary pressure obtained with the two methods in patients at risk for ventilator-induced-lung-injury
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Federico Franchi, MD
role: Principal Investigator
affiliation: University of Siena, Depatment of Medical Biotechnology
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Siena
investigator full name: Federico Franchi
investigator title: Principal Investigator; Associate professor of Anesthesiology; Anesthesia and Intensive Care Unit, Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
sharing ipd: No