xml: <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/NCT06035146</url>
    </required_header>
    <id_info>
      <org_study_id>25/RVO-FNOs/2022</org_study_id>
      <nct_id>NCT06035146</nct_id>
    </id_info>
    <brief_title>Mechanical Ventilation in Patients With Lung Impairment Controlled by the Mechanical Energy of the Respiratory System</brief_title>
    <official_title>Protective Ventilation in Patients With Lung Impairment on Mechanical Ventilation Controlled by the Mechanical Energy of the Respiratory System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Ostrava</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital Ostrava</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>
        A project aimed at expanding the monitoring of mechanical energy (ME) in patients on&#xD;
        mechanical ventilation (MV), with the aim of contributing to reducing the influence of the&#xD;
        device for mechanical ventilation of patients on the lung parenchyma by setting parameters&#xD;
        that will lead to lower ventilation energy.&#xD;
  &#xD;
        According to the parameters set on the device for mechanical ventilation, the mechanical&#xD;
        energy will be calculated, which the physician in the interventional arm of the study will be&#xD;
        able to use to change the mechanical ventilation settings. The physician will follow the best&#xD;
        clinical practice, and in the non-intervention group, the MV setting will be conventional.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Mechanical ventilation (MV) in patients with acute respiratory failure (ARF) is one of the&#xD;
        most common causes of hospitalization in the intensive care unit (ICU). ARF can be associated&#xD;
        with severe forms of lung injury, the so-called ARDS (adult respiratory distress syndrome).&#xD;
        Despite progress in the management of patients with ARDS, the mortality of these patients&#xD;
        remains high, with in-hospital mortality reaching up to 45%. In patients with severe ARDS,&#xD;
        mechanical ventilation can damage the lung parenchyma and cause ventilator-induced lung&#xD;
        injury (VILI), which further worsens the patient's prognosis.&#xD;
  &#xD;
        The result of setting the individual parameters of mechanical ventilation is the energy that&#xD;
        the device exerts on the lung parenchyma, which ensures the opening of the lungs and a change&#xD;
        in their volume related to gas exchange during breathing.&#xD;
  &#xD;
        Routine laboratory values of blood gases and parameters of inflammation (CRP, PCT) will be&#xD;
        recorded; which is part of routine clinical practice and standard patient care unrelated to&#xD;
        the study.&#xD;
  &#xD;
        As part of a prospective randomized study, a system for monitoring mechanical energy at the&#xD;
        patient's bedside will be developed. Patients will be randomized into two groups - the&#xD;
        intervention arm (mechanical ventilation controlled according to ME) and the non-intervention&#xD;
        arm (conventional method of conducting mechanical ventilation).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</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>
      <intervention_model_description>The study subjects will be randomized into two parallel groups.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>No masking will be used in the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The level of mechanical energy (in Joules/min)</measure>
      <time_frame>up to 14 days</time_frame>
      <description>The level of mechanical energy will be measured (in Joules/min) in both study arms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The number of days on mechanical ventilation</measure>
      <time_frame>up to 14 days</time_frame>
      <description>The number of days on mechanical ventilation will be observed in both study arms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effect of mechanical energy on patient mortality</measure>
      <time_frame>up to 14 days</time_frame>
      <description>The effect of mechanical energy on patient mortality will be analysed in both study arms. A mortality rate is the number of deaths due to a disease divided by the total population.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effect of mechanical energy on hospital mortality</measure>
      <time_frame>up to 8 weeks</time_frame>
      <description>The effect of mechanical energy on hospital mortality will be analysed in both study arms. A mortality rate is the number of deaths due to a disease divided by the total population.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>ARDS</condition>
    <condition>Lung Injury, Ventilator Induced</condition>
    <arm_group>
      <arm_group_label>Mechanical energy monitoring</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the study subjects randomized into this arm, the value of mechanical energy will be monitored during mechanical ventilation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional mechanical ventilation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Study subjects randomized into this arm will receive conventional mechanical ventilation, to the best of the physician's knowledge.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Mechanical energy monitoring</intervention_name>
      <description>Monitoring of the mechanical energy acting on the lung parenchyma during mechanical ventilation.</description>
      <arm_group_label>Mechanical energy monitoring</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Conventional mechanical ventilation</intervention_name>
      <description>The conventional procedure of mechanical ventilation controlled according to the physician's decision.</description>
      <arm_group_label>Conventional mechanical ventilation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with fully controlled mechanical ventilation&#xD;
  &#xD;
            -  patients older than 18 years&#xD;
  &#xD;
            -  patients with lung disease (pneumonia, ARDS)&#xD;
  &#xD;
            -  expected duration of mechanical ventilation longer than 48 hours&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnant women, when this fact is stated in the admission protocol&#xD;
  &#xD;
            -  inclusion in the study in a period longer than 24 hours from the start of mechanical&#xD;
               ventilation (from admission to the Anesthesiology and Resuscitation Department)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Filip Burša, MD,PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital Ostrava</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jiří Hynčica</last_name>
      <phone>0042059737</phone>
      <phone_ext>2587</phone_ext>
      <email>jiri.hyncica@fno.cz</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Hospital Ostrava</name>
        <address>
          <city>Ostrava</city>
          <state>Moravian-Silesian Region</state>
          <zip>70852</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jiří Hynčica</last_name>
        <phone>0042059737</phone>
        <phone_ext>258'7</phone_ext>
        <email>jiri.hyncica@fno.cz</email>
      </contact>
      <investigator>
        <last_name>Filip Burša, MD,PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jan Máca, Assoc.Prof.,MD,PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ondřej Jor, MD,PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jan Štigler, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <reference>
      <citation>Papazian L, Calfee CS, Chiumello D, Luyt CE, Meyer NJ, Sekiguchi H, Matthay MA, Meduri GU. Diagnostic workup for ARDS patients. Intensive Care Med. 2016 May;42(5):674-685. doi: 10.1007/s00134-016-4324-5. Epub 2016 Mar 23.</citation>
      <PMID>27007111</PMID>
    </reference>
    <reference>
      <citation>Maca J, Jor O, Holub M, Sklienka P, Bursa F, Burda M, Janout V, Sevcik P. Past and Present ARDS Mortality Rates: A Systematic Review. Respir Care. 2017 Jan;62(1):113-122. doi: 10.4187/respcare.04716. Epub 2016 Nov 1.</citation>
      <PMID>27803355</PMID>
    </reference>
    <reference>
      <citation>Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.</citation>
      <PMID>10793162</PMID>
    </reference>
    <reference>
      <citation>Rittayamai N, Brochard L. Recent advances in mechanical ventilation in patients with acute respiratory distress syndrome. Eur Respir Rev. 2015 Mar;24(135):132-40. doi: 10.1183/09059180.00012414.</citation>
      <PMID>25726563</PMID>
    </reference>
    <reference>
      <citation>Guerin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384. doi: 10.1186/s13054-016-1556-2.</citation>
      <PMID>27894328</PMID>
    </reference>
    <reference>
      <citation>Gattinoni L, Marini JJ, Pesenti A, Quintel M, Mancebo J, Brochard L. The &quot;baby lung&quot; became an adult. Intensive Care Med. 2016 May;42(5):663-673. doi: 10.1007/s00134-015-4200-8. Epub 2016 Jan 18.</citation>
      <PMID>26781952</PMID>
    </reference>
    <reference>
      <citation>de Prost N, Ricard JD, Saumon G, Dreyfuss D. Ventilator-induced lung injury: historical perspectives and clinical implications. Ann Intensive Care. 2011 Jul 23;1(1):28. doi: 10.1186/2110-5820-1-28.</citation>
      <PMID>21906379</PMID>
    </reference>
    <reference>
      <citation>Nieman GF, Satalin J, Andrews P, Habashi NM, Gatto LA. Lung stress, strain, and energy load: engineering concepts to understand the mechanism of ventilator-induced lung injury (VILI). Intensive Care Med Exp. 2016 Dec;4(1):16. doi: 10.1186/s40635-016-0090-5. Epub 2016 Jun 18.</citation>
      <PMID>27316442</PMID>
    </reference>
    <reference>
      <citation>Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.</citation>
      <PMID>27620287</PMID>
    </reference>
    <reference>
      <citation>Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.</citation>
      <PMID>26872367</PMID>
    </reference>
    <reference>
      <citation>Chiumello D, Gotti M, Guanziroli M, Formenti P, Umbrello M, Pasticci I, Mistraletti G, Busana M. Bedside calculation of mechanical power during volume- and pressure-controlled mechanical ventilation. Crit Care. 2020 Jul 11;24(1):417. doi: 10.1186/s13054-020-03116-w.</citation>
      <PMID>32653011</PMID>
    </reference>
    <reference>
      <citation>Giosa L, Busana M, Pasticci I, Bonifazi M, Macri MM, Romitti F, Vassalli F, Chiumello D, Quintel M, Marini JJ, Gattinoni L. Mechanical power at a glance: a simple surrogate for volume-controlled ventilation. Intensive Care Med Exp. 2019 Nov 27;7(1):61. doi: 10.1186/s40635-019-0276-8.</citation>
      <PMID>31773328</PMID>
    </reference>
    <reference>
      <citation>Becher T, van der Staay M, Schadler D, Frerichs I, Weiler N. Calculation of mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Sep;45(9):1321-1323. doi: 10.1007/s00134-019-05636-8. Epub 2019 May 17. No abstract available.</citation>
      <PMID>31101961</PMID>
    </reference>
    <reference>
      <citation>Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5.</citation>
      <PMID>30291378</PMID>
    </reference>
    <reference>
      <citation>Mietto C, Malbrain ML, Chiumello D. Transpulmonary pressure monitoring during mechanical ventilation: a bench-to-bedside review. Anaesthesiol Intensive Ther. 2015;47 Spec No:s27-37. doi: 10.5603/AIT.a2015.0065. Epub 2015 Nov 17.</citation>
      <PMID>26575165</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>February 15, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>mechanical ventilation</keyword>
    <keyword>adult respiratory distress syndrome</keyword>
    <keyword>ventilator-induced lung injury</keyword>
    <keyword>mechanical energy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Injury</mesh_term>
      <mesh_term>Ventilator-Induced Lung Injury</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no plan to make individual participant data available to other researchers. The data may be provided upon request.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035146
  org study id: 25/RVO-FNOs/2022
  nct id: NCT06035146
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A project aimed at expanding the monitoring of mechanical energy (ME) in patients on
        mechanical ventilation (MV), with the aim of contributing to reducing the influence of the
        device for mechanical ventilation of patients on the lung parenchyma by setting parameters
        that will lead to lower ventilation energy.
  
        According to the parameters set on the device for mechanical ventilation, the mechanical
        energy will be calculated, which the physician in the interventional arm of the study will be
        able to use to change the mechanical ventilation settings. The physician will follow the best
        clinical practice, and in the non-intervention group, the MV setting will be conventional.
  Mechanical ventilation (MV) in patients with acute respiratory failure (ARF) is one of the
        most common causes of hospitalization in the intensive care unit (ICU). ARF can be associated
        with severe forms of lung injury, the so-called ARDS (adult respiratory distress syndrome).
        Despite progress in the management of patients with ARDS, the mortality of these patients
        remains high, with in-hospital mortality reaching up to 45%. In patients with severe ARDS,
        mechanical ventilation can damage the lung parenchyma and cause ventilator-induced lung
        injury (VILI), which further worsens the patient's prognosis.
  
        The result of setting the individual parameters of mechanical ventilation is the energy that
        the device exerts on the lung parenchyma, which ensures the opening of the lungs and a change
        in their volume related to gas exchange during breathing.
  
        Routine laboratory values of blood gases and parameters of inflammation (CRP, PCT) will be
        recorded; which is part of routine clinical practice and standard patient care unrelated to
        the study.
  
        As part of a prospective randomized study, a system for monitoring mechanical energy at the
        patient's bedside will be developed. Patients will be randomized into two groups - the
        intervention arm (mechanical ventilation controlled according to ME) and the non-intervention
        arm (conventional method of conducting mechanical ventilation).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study subjects will be randomized into two parallel groups.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: No masking will be used in the study.
  measure: The level of mechanical energy (in Joules/min)
  time frame: up to 14 days
  description: The level of mechanical energy will be measured (in Joules/min) in both study arms.
  measure: The number of days on mechanical ventilation
  time frame: up to 14 days
  description: The number of days on mechanical ventilation will be observed in both study arms.
  measure: The effect of mechanical energy on patient mortality
  time frame: up to 14 days
  description: The effect of mechanical energy on patient mortality will be analysed in both study arms. A mortality rate is the number of deaths due to a disease divided by the total population.
  measure: The effect of mechanical energy on hospital mortality
  time frame: up to 8 weeks
  description: The effect of mechanical energy on hospital mortality will be analysed in both study arms. A mortality rate is the number of deaths due to a disease divided by the total population.
  arm group label: Mechanical energy monitoring
  arm group type: Experimental
  description: In the study subjects randomized into this arm, the value of mechanical energy will be monitored during mechanical ventilation.
  arm group label: Conventional mechanical ventilation
  arm group type: Active Comparator
  description: Study subjects randomized into this arm will receive conventional mechanical ventilation, to the best of the physician's knowledge.
  intervention type: Procedure
  intervention name: Mechanical energy monitoring
  description: Monitoring of the mechanical energy acting on the lung parenchyma during mechanical ventilation.
  arm group label: Mechanical energy monitoring
  intervention type: Procedure
  intervention name: Conventional mechanical ventilation
  description: The conventional procedure of mechanical ventilation controlled according to the physician's decision.
  arm group label: Conventional mechanical ventilation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Filip Burša, MD,PhD
  role: Principal Investigator
  affiliation: University Hospital Ostrava
  last name: Jiří Hynčica
  phone: 0042059737
  phone ext: 2587
  email: jiri.hyncica@fno.cz
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Czechia
  citation: Papazian L, Calfee CS, Chiumello D, Luyt CE, Meyer NJ, Sekiguchi H, Matthay MA, Meduri GU. Diagnostic workup for ARDS patients. Intensive Care Med. 2016 May;42(5):674-685. doi: 10.1007/s00134-016-4324-5. Epub 2016 Mar 23.
  PMID: 27007111
  citation: Maca J, Jor O, Holub M, Sklienka P, Bursa F, Burda M, Janout V, Sevcik P. Past and Present ARDS Mortality Rates: A Systematic Review. Respir Care. 2017 Jan;62(1):113-122. doi: 10.4187/respcare.04716. Epub 2016 Nov 1.
  PMID: 27803355
  citation: Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
  PMID: 10793162
  citation: Rittayamai N, Brochard L. Recent advances in mechanical ventilation in patients with acute respiratory distress syndrome. Eur Respir Rev. 2015 Mar;24(135):132-40. doi: 10.1183/09059180.00012414.
  PMID: 25726563
  citation: Guerin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384. doi: 10.1186/s13054-016-1556-2.
  PMID: 27894328
  citation: Gattinoni L, Marini JJ, Pesenti A, Quintel M, Mancebo J, Brochard L. The "baby lung" became an adult. Intensive Care Med. 2016 May;42(5):663-673. doi: 10.1007/s00134-015-4200-8. Epub 2016 Jan 18.
  PMID: 26781952
  citation: de Prost N, Ricard JD, Saumon G, Dreyfuss D. Ventilator-induced lung injury: historical perspectives and clinical implications. Ann Intensive Care. 2011 Jul 23;1(1):28. doi: 10.1186/2110-5820-1-28.
  PMID: 21906379
  citation: Nieman GF, Satalin J, Andrews P, Habashi NM, Gatto LA. Lung stress, strain, and energy load: engineering concepts to understand the mechanism of ventilator-induced lung injury (VILI). Intensive Care Med Exp. 2016 Dec;4(1):16. doi: 10.1186/s40635-016-0090-5. Epub 2016 Jun 18.
  PMID: 27316442
  citation: Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
  PMID: 27620287
  citation: Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
  PMID: 26872367
  citation: Chiumello D, Gotti M, Guanziroli M, Formenti P, Umbrello M, Pasticci I, Mistraletti G, Busana M. Bedside calculation of mechanical power during volume- and pressure-controlled mechanical ventilation. Crit Care. 2020 Jul 11;24(1):417. doi: 10.1186/s13054-020-03116-w.
  PMID: 32653011
  citation: Giosa L, Busana M, Pasticci I, Bonifazi M, Macri MM, Romitti F, Vassalli F, Chiumello D, Quintel M, Marini JJ, Gattinoni L. Mechanical power at a glance: a simple surrogate for volume-controlled ventilation. Intensive Care Med Exp. 2019 Nov 27;7(1):61. doi: 10.1186/s40635-019-0276-8.
  PMID: 31773328
  citation: Becher T, van der Staay M, Schadler D, Frerichs I, Weiler N. Calculation of mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Sep;45(9):1321-1323. doi: 10.1007/s00134-019-05636-8. Epub 2019 May 17. No abstract available.
  PMID: 31101961
  citation: Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5.
  PMID: 30291378
  citation: Mietto C, Malbrain ML, Chiumello D. Transpulmonary pressure monitoring during mechanical ventilation: a bench-to-bedside review. Anaesthesiol Intensive Ther. 2015;47 Spec No:s27-37. doi: 10.5603/AIT.a2015.0065. Epub 2015 Nov 17.
  PMID: 26575165
  responsible party type: Sponsor
  mesh term: Lung Injury
  mesh term: Ventilator-Induced Lung Injury
  sharing ipd: No
  ipd description: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.