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/NCT05990348</url>
    </required_header>
    <id_info>
      <org_study_id>4856</org_study_id>
      <nct_id>NCT05990348</nct_id>
    </id_info>
    <brief_title>Estimation of the Diaphragm Electrical Activity and Intercostal Thickening Fraction During Different Pattern of Mechanical Ventilation: PSV Versus NAVA</brief_title>
    <acronym>InterThick</acronym>
    <official_title>Estimation of the Diaphragm Electrical Activity and Intercostal Thickening Fraction During Different Pattern of Mechanical Ventilation: PSV Versus NAVA</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</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>
        the introduction of new MV modalities has shown promising results in reducing the incidence&#xD;
        of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle&#xD;
        preservation. Among them, the Neurally Adjust Ventilatory Assist (NAVA) seemed to be&#xD;
        associated with lower incidence of weaning failure and subsequent duration of mechanical&#xD;
        ventilation, compared to standard modalities like the Pressure Support Ventilation (PSV) .&#xD;
        Moreover, NAVA allows the evaluation of the diaphragm electrical activity (EAdi), an index of&#xD;
        diaphragmatic neural respiratory drive. However, no study has compared TFic values during PSV&#xD;
        and NAVA modalities in patients with difficult weaning from MV admitted in ICU.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Respiratory muscles dysfunction is one of the main causes leading to failure of weaning from&#xD;
        mechanical ventilation (MV) in critically ill patients. Muscular activity is important during&#xD;
        the inspiratory phase of ventilation, which is mainly due to diaphragm and external&#xD;
        intercostal muscles. Diaphragm dysfunction is frequent among critically ill patients and&#xD;
        ranges from 33 to 95% . Although several indexes have been investigated to help clinician in&#xD;
        identifying its disturbance, their clinical value is controversial . External intercostal&#xD;
        muscles dysfunction epidemiology is unknown because of lack of non-invasive tool to&#xD;
        investigate such condition. However, the echography assessment of intercostal muscles&#xD;
        thickening fraction (TFic) has shown promising results in this field as a non-invasive tool&#xD;
        to assess inspiratory muscle function and predict weaning failure .&#xD;
  &#xD;
        On the other hand, the introduction of new MV modalities has shown promising results in&#xD;
        reducing the incidence of weaning failure, mainly due to a more physiologic approach which&#xD;
        allows respiratory muscle preservation. Among them, the Neurally Adjust Ventilatory Assist&#xD;
        (NAVA) seemed to be associated with lower incidence of weaning failure and subsequent&#xD;
        duration of mechanical ventilation, compared to standard modalities like the Pressure Support&#xD;
        Ventilation (PSV) [. Moreover, NAVA allows the evaluation of the diaphragm electrical&#xD;
        activity (EAdi), an index of diaphragmatic neural respiratory drive . A recent study suggests&#xD;
        that EAdi and derived parameters, may be helpful to predict weaning failure in chronic&#xD;
        obstructive pulmonary disease (COPD) patients .&#xD;
  &#xD;
        However, no study has compared TFic values during PSV and NAVA modalities in patients with&#xD;
        difficult weaning from MV admitted in ICU.&#xD;
  &#xD;
        the aim of this study will be the comparison of TFic values during PSV and NAVA modalities in&#xD;
        patients with difficult weaning from MV admitted in ICU and the assessment of the inspiratory&#xD;
        effort parameters and the occurrence of respiratory asynchrony in patients with difficult&#xD;
        weaning from MV admitted in ICU.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Anticipated">January 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 26, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>intercostal thickening fraction</measure>
      <time_frame>From date of enrollment until the date of extubation (up to seven days)</time_frame>
      <description>intercostal thickening fraction values during PSV and NAVA</description>
    </primary_outcome>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Respiratory Failure</condition>
    <condition>Weaning Failure</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>difficult weaning patients</intervention_name>
      <description>intercostal thickening fraction values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Critically ill patients on mechanical ventilation (MV) for at least 24 hours, who have&#xD;
          failed at least one weaning attempt, hospitalized at the Intensive Care Unit of Fondazione&#xD;
          Policlinico Universitario A. Gemelli IRCCS.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients who have failed at least one weaning attempt&#xD;
  &#xD;
            -  mechanical ventilation for at least 24 hours&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Obesity (Body Mass Index &gt; 35 kg/m2)&#xD;
  &#xD;
            -  Contraindication to the insert of a nasogastric tube&#xD;
  &#xD;
            -  Neuromuscular diseases&#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_contact>
      <last_name>giorgia GS spinazzola, md</last_name>
      <phone>0630154507</phone>
      <email>giorgia.spinazzola@policlinicogemelli.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>gianmarco gm maresca, md</last_name>
      <phone>0630154507</phone>
      <email>gianmarco.maresca@policlinicogemelli.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Giorgia Spinazzola</name>
        <address>
          <city>Rome</city>
          <zip>00168</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>giorgia spinazzola</last_name>
        <phone>+393297813925</phone>
        <email>giorgia.spinazzola@policlinicogemelli.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <results_reference>
      <citation>Abdelwahed WM, Abd Elghafar MS, Amr YM, Alsherif SEI, Eltomey MA. Prospective study: Diaphragmatic thickness as a predictor index for weaning from mechanical ventilation. J Crit Care. 2019 Aug;52:10-15. doi: 10.1016/j.jcrc.2019.03.006. Epub 2019 Mar 15. No abstract available.</citation>
      <PMID>30904733</PMID>
    </results_reference>
    <results_reference>
      <citation>Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.</citation>
      <PMID>27677861</PMID>
    </results_reference>
    <results_reference>
      <citation>Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.</citation>
      <PMID>32516052</PMID>
    </results_reference>
    <results_reference>
      <citation>Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.</citation>
      <PMID>25879592</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
      <investigator_full_name>SPINAZZOLA GIORGIA</investigator_full_name>
      <investigator_title>Medical Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>We will assess the availability of data based on the results</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/NCT05990348
  org study id: 4856
  nct id: NCT05990348
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  the introduction of new MV modalities has shown promising results in reducing the incidence
        of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle
        preservation. Among them, the Neurally Adjust Ventilatory Assist (NAVA) seemed to be
        associated with lower incidence of weaning failure and subsequent duration of mechanical
        ventilation, compared to standard modalities like the Pressure Support Ventilation (PSV) .
        Moreover, NAVA allows the evaluation of the diaphragm electrical activity (EAdi), an index of
        diaphragmatic neural respiratory drive. However, no study has compared TFic values during PSV
        and NAVA modalities in patients with difficult weaning from MV admitted in ICU.
  Respiratory muscles dysfunction is one of the main causes leading to failure of weaning from
        mechanical ventilation (MV) in critically ill patients. Muscular activity is important during
        the inspiratory phase of ventilation, which is mainly due to diaphragm and external
        intercostal muscles. Diaphragm dysfunction is frequent among critically ill patients and
        ranges from 33 to 95% . Although several indexes have been investigated to help clinician in
        identifying its disturbance, their clinical value is controversial . External intercostal
        muscles dysfunction epidemiology is unknown because of lack of non-invasive tool to
        investigate such condition. However, the echography assessment of intercostal muscles
        thickening fraction (TFic) has shown promising results in this field as a non-invasive tool
        to assess inspiratory muscle function and predict weaning failure .
  
        On the other hand, the introduction of new MV modalities has shown promising results in
        reducing the incidence of weaning failure, mainly due to a more physiologic approach which
        allows respiratory muscle preservation. Among them, the Neurally Adjust Ventilatory Assist
        (NAVA) seemed to be associated with lower incidence of weaning failure and subsequent
        duration of mechanical ventilation, compared to standard modalities like the Pressure Support
        Ventilation (PSV) [. Moreover, NAVA allows the evaluation of the diaphragm electrical
        activity (EAdi), an index of diaphragmatic neural respiratory drive . A recent study suggests
        that EAdi and derived parameters, may be helpful to predict weaning failure in chronic
        obstructive pulmonary disease (COPD) patients .
  
        However, no study has compared TFic values during PSV and NAVA modalities in patients with
        difficult weaning from MV admitted in ICU.
  
        the aim of this study will be the comparison of TFic values during PSV and NAVA modalities in
        patients with difficult weaning from MV admitted in ICU and the assessment of the inspiratory
        effort parameters and the occurrence of respiratory asynchrony in patients with difficult
        weaning from MV admitted in ICU.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: intercostal thickening fraction
  time frame: From date of enrollment until the date of extubation (up to seven days)
  description: intercostal thickening fraction values during PSV and NAVA
  intervention type: Other
  intervention name: difficult weaning patients
  description: intercostal thickening fraction values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: giorgia GS spinazzola, md
  phone: 0630154507
  email: giorgia.spinazzola@policlinicogemelli.it
  last name: gianmarco gm maresca, md
  phone: 0630154507
  email: gianmarco.maresca@policlinicogemelli.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  citation: Abdelwahed WM, Abd Elghafar MS, Amr YM, Alsherif SEI, Eltomey MA. Prospective study: Diaphragmatic thickness as a predictor index for weaning from mechanical ventilation. J Crit Care. 2019 Aug;52:10-15. doi: 10.1016/j.jcrc.2019.03.006. Epub 2019 Mar 15. No abstract available.
  PMID: 30904733
  citation: Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.
  PMID: 27677861
  citation: Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.
  PMID: 32516052
  citation: Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.
  PMID: 25879592
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  investigator full name: SPINAZZOLA GIORGIA
  investigator title: Medical Doctor
  mesh term: Respiratory Insufficiency
  sharing ipd: Undecided
  ipd description: We will assess the availability of data based on the results