<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/NCT04445961</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-VENT</org_study_id>
    <nct_id>NCT04445961</nct_id>
  </id_info>
  <brief_title>Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure</brief_title>
  <acronym>COVID-VENT</acronym>
  <official_title>Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure: Multicentral Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>I.M. Sechenov First Moscow State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>I.M. Sechenov First Moscow State Medical University</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>
      Data on respiratory mechanics and gas exchange in acute respiratory failure in COVID-19&#xD;
      patients is limited. Knowledge of respiratory mechanics and gas exchange in COVID-19 can lead&#xD;
      to different selection of mechanical ventilation strategy, reduce ventilator-associated lung&#xD;
      injury and improve outcomes. The objective of the study is to evaluate the respiratory&#xD;
      mechanics, lung recruitability and gas exchange in COVID-19 -associated acute respiratory&#xD;
      failure during the whole course of mechanical ventilation - invasive or non-invasive.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In December 2019, an outbreak of a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China and&#xD;
      rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a&#xD;
      pandemic on March 11th, 2020. The clinical disease (COVID-19) results in critical illness in&#xD;
      about 5% of patients with predominant acute respiratory failure.&#xD;
&#xD;
      The goal of the study is the evaluation of the respiratory mechanics (peak inspiratory&#xD;
      pressure (PIP), plateau pressure (Pplat), static compliance (Cstat), driving pressure (DP) at&#xD;
      different positive end-expiratory pressure (PEEP) levels and different tidal volumes (Vt)&#xD;
      (6-8 ml/kg ideal body weight), lung recruitability (by change of DP and oxygenation) and gas&#xD;
      exchange (PaO2/FiO2 ratio and alveolar dead space) in COVID-19 -associated acute respiratory&#xD;
      failure during the whole course of mechanical ventilation - invasive or non-invasive for&#xD;
      selection of safe and effective PEEP level, Vt, respiratory rate (RR) and inspiratory oxygen&#xD;
      fraction (FiO2) during the whole course of mechanical ventilation - invasive or non-invasive.&#xD;
&#xD;
      This study is multicentral observational trial in 3 University clinics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">August 14, 2020</completion_date>
  <primary_completion_date type="Actual">August 14, 2020</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>Optimum positive end-expiratory pressure (PEEP) level</measure>
    <time_frame>On day 1 during mechanical ventilation</time_frame>
    <description>Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Optimum positive end-expiratory pressure (PEEP) level</measure>
    <time_frame>On day 7 during mechanical ventilation</time_frame>
    <description>Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with recruitable lung</measure>
    <time_frame>On day 1 during mechanical ventilation</time_frame>
    <description>Peripheral capillary oxygen saturation (SpO2) change from 90% after recruitment maneuver (doubled tidal volume for 15 respiratory cycles) - if peripheral capillary oxygen saturation (SpO2) after recruitment maneuver more than 95%-recruitable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with recruitable lung</measure>
    <time_frame>On day 7 during mechanical ventilation</time_frame>
    <description>Peripheral capillary oxygen saturation (SpO2) change from 90% after recruitment maneuver (doubled tidal volume for 15 respiratory cycles) - if peripheral capillary oxygen saturation (SpO2) after recruitment maneuver more than 95%-recruitable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in alveolar dead space</measure>
    <time_frame>On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation</time_frame>
    <description>Calculation of the alveolar dead space using end-tidal carbon dioxide measurement and arterial carbon dioxide tension measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plethysmogram variability during recruitment maneuver</measure>
    <time_frame>On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation</time_frame>
    <description>Measurement of plethysmogram variability before and during recruitment maneuver</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio</measure>
    <time_frame>On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation</time_frame>
    <description>Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimum positive end-expiratory pressure (PEEP) level</measure>
    <time_frame>On day 3, 5, 10, 14, 21 during mechanical ventilation</time_frame>
    <description>Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in driving pressure with different positive end-expiratory pressure (PEEP) levels</measure>
    <time_frame>On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation</time_frame>
    <description>Driving pressure calculation at different positive end-expiratory pressure (PEEP) levels (8, 10, 12, 14)</description>
  </secondary_outcome>
  <enrollment type="Actual">117</enrollment>
  <condition>SARS Pneumonia</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Respiratory mechanics measurement</intervention_name>
    <description>Measurement of peak inspiratory pressure, plateau pressure, calculation of static compliance and driving pressure</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Gas exchange measurement</intervention_name>
    <description>Measurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio and alveolar dead space</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with COVID-19 requiring respiratory support&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients with COVID-19 and acute respiratory failure on invasive and noninvasive&#xD;
             ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who reached the following goals at conventional oxygen therapy (oxygen flow &lt;&#xD;
             15 l/min): peripheral capillary oxygen saturation(SpO2) &gt; 93%, no visible work of&#xD;
             auxiliary respiratory muscles, no fatigue, stable hemodynamics (no need in any&#xD;
             catecholamines and/or life-threatening heart rhythm abnormalities),&#xD;
&#xD;
          -  less than 24 ours in intensive care unit (ICU) by any reason,&#xD;
&#xD;
          -  lung emphysema,&#xD;
&#xD;
          -  primary lung diseases (chronic obstructive lung disease-COPD, interstitial lung&#xD;
             diseases, etc) or tumour metastases in lungs,&#xD;
&#xD;
          -  chronic decompensated diseases with extrapulmonary organ dysfunction (tumour&#xD;
             progression, liver cirrhosis, congestive heart failure),&#xD;
&#xD;
          -  atonic coma.&#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>Andrey I Yaroshetskiy, Dr.Med.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sechenov University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sechenov University Clinic #1</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sechenov University Clinic #3</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sechenov University Clinic #4</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <reference>
    <citation>Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.</citation>
    <PMID>25693014</PMID>
  </reference>
  <results_reference>
    <citation>Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.</citation>
    <PMID>32291463</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.</citation>
    <PMID>32031570</PMID>
  </results_reference>
  <results_reference>
    <citation>Toufen Junior C, De Santis Santiago RR, Hirota AS, Carvalho ARS, Gomes S, Amato MBP, Carvalho CRR. Driving pressure and long-term outcomes in moderate/severe acute respiratory distress syndrome. Ann Intensive Care. 2018 Dec 7;8(1):119. doi: 10.1186/s13613-018-0469-4.</citation>
    <PMID>30535520</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 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>August 26, 2020</last_update_submitted>
  <last_update_submitted_qc>August 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS Pneumonia</keyword>
  <keyword>ARDS</keyword>
  <keyword>COVID-19</keyword>
  <keyword>compliance</keyword>
  <keyword>recruitability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <!-- 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/NCT04445961
org study id: COVID-VENT
nct id: NCT04445961
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Data on respiratory mechanics and gas exchange in acute respiratory failure in COVID-19
      patients is limited. Knowledge of respiratory mechanics and gas exchange in COVID-19 can lead
      to different selection of mechanical ventilation strategy, reduce ventilator-associated lung
      injury and improve outcomes. The objective of the study is to evaluate the respiratory
      mechanics, lung recruitability and gas exchange in COVID-19 -associated acute respiratory
      failure during the whole course of mechanical ventilation - invasive or non-invasive.
In December 2019, an outbreak of a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China and
      rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a
      pandemic on March 11th, 2020. The clinical disease (COVID-19) results in critical illness in
      about 5% of patients with predominant acute respiratory failure.

      The goal of the study is the evaluation of the respiratory mechanics (peak inspiratory
      pressure (PIP), plateau pressure (Pplat), static compliance (Cstat), driving pressure (DP) at
      different positive end-expiratory pressure (PEEP) levels and different tidal volumes (Vt)
      (6-8 ml/kg ideal body weight), lung recruitability (by change of DP and oxygenation) and gas
      exchange (PaO2/FiO2 ratio and alveolar dead space) in COVID-19 -associated acute respiratory
      failure during the whole course of mechanical ventilation - invasive or non-invasive for
      selection of safe and effective PEEP level, Vt, respiratory rate (RR) and inspiratory oxygen
      fraction (FiO2) during the whole course of mechanical ventilation - invasive or non-invasive.

      This study is multicentral observational trial in 3 University clinics.
observational model: Case-Only
time perspective: Prospective
measure: Optimum positive end-expiratory pressure (PEEP) level
time frame: On day 1 during mechanical ventilation
description: Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)
measure: Optimum positive end-expiratory pressure (PEEP) level
time frame: On day 7 during mechanical ventilation
description: Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)
measure: Number of patients with recruitable lung
time frame: On day 1 during mechanical ventilation
description: Peripheral capillary oxygen saturation (SpO2) change from 90% after recruitment maneuver (doubled tidal volume for 15 respiratory cycles) - if peripheral capillary oxygen saturation (SpO2) after recruitment maneuver more than 95%-recruitable
measure: Number of patients with recruitable lung
time frame: On day 7 during mechanical ventilation
description: Peripheral capillary oxygen saturation (SpO2) change from 90% after recruitment maneuver (doubled tidal volume for 15 respiratory cycles) - if peripheral capillary oxygen saturation (SpO2) after recruitment maneuver more than 95%-recruitable
measure: Change in alveolar dead space
time frame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation
description: Calculation of the alveolar dead space using end-tidal carbon dioxide measurement and arterial carbon dioxide tension measurement
measure: Change in plethysmogram variability during recruitment maneuver
time frame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation
description: Measurement of plethysmogram variability before and during recruitment maneuver
measure: Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
time frame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation
description: Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement
measure: Optimum positive end-expiratory pressure (PEEP) level
time frame: On day 3, 5, 10, 14, 21 during mechanical ventilation
description: Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)
measure: Change in driving pressure with different positive end-expiratory pressure (PEEP) levels
time frame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation
description: Driving pressure calculation at different positive end-expiratory pressure (PEEP) levels (8, 10, 12, 14)
intervention type: Diagnostic Test
intervention name: Respiratory mechanics measurement
description: Measurement of peak inspiratory pressure, plateau pressure, calculation of static compliance and driving pressure
intervention type: Diagnostic Test
intervention name: Gas exchange measurement
description: Measurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio and alveolar dead space
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Andrey I Yaroshetskiy, Dr.Med.Sc.
role: Principal Investigator
affiliation: Sechenov University
facility: 
facility: 
facility: 
country: Russian Federation
citation: Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
PMID: 25693014
citation: Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.
PMID: 32291463
citation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
PMID: 32031570
citation: Toufen Junior C, De Santis Santiago RR, Hirota AS, Carvalho ARS, Gomes S, Amato MBP, Carvalho CRR. Driving pressure and long-term outcomes in moderate/severe acute respiratory distress syndrome. Ann Intensive Care. 2018 Dec 7;8(1):119. doi: 10.1186/s13613-018-0469-4.
PMID: 30535520
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Respiratory Insufficiency