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/NCT06004206</url>
    </required_header>
    <id_info>
      <org_study_id>NiVnPSV</org_study_id>
      <nct_id>NCT06004206</nct_id>
    </id_info>
    <brief_title>Patient-ventilator Interaction During NIV With Helmet: a Comparison Between PSV and the New NIV NPS Software</brief_title>
    <official_title>Patient-ventilator Interaction During NIV With Helmet: a Comparison Between PSV and the New NIV NPS Software</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ASL Novara</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ASL Novara</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to evaluate if neural pressure support ventilation is able&#xD;
        to improve patient-ventilator synchrony, in ICU patients undergoing non-invasive ventilation&#xD;
        (NIV). The main question it aims to answer is:&#xD;
  &#xD;
        • Is neural pressure support ventilation better than the pressure support ventilation with&#xD;
        respect to patient-ventilator synchrony during helmet NIV?&#xD;
  &#xD;
        Researchers will compare neural pressure support ventilation versus pressure support&#xD;
        ventilation (Gold standard assisted mode in Europe) to see if the new mode improve&#xD;
        patient-ventilator synchrony.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Non-Invasive Ventilation (NIV) has found many different uses in clinical settings, shortening&#xD;
        intubation times and preventing orotracheal intubation. NIV success is highly affected by&#xD;
        patient comfort and patient-ventilator synchrony. The helmet is one of the most comfortable&#xD;
        interfaces, even if synchrony is low due to dead space. The use of Neurally Adjusted&#xD;
        Ventilatory Assist (NAVA), in which the Electrical Activity of the Diaphragm (EAdi) drives&#xD;
        the ventilator, has shown improvement in comfort and synchrony but still some limitation with&#xD;
        helmet, due to the long pressurization time. Pressure-Support Ventilation (PSV) is still the&#xD;
        most used and diffused assisted mode in Europe due to its simplicity and effectiveness in&#xD;
        helmet-NIV. The aim of this study is to test a new ventilation software called Neural&#xD;
        Pressure Support Ventilation (nPSV), which merges the rapid pressurization of PSV along with&#xD;
        the EAdi trigger, onto a population of 24 critical care patients ventilated with a helmet&#xD;
        NIV.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2020</start_date>
    <completion_date type="Actual">June 15, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Patients will be ventilated in nPSV or PSV (according to randomization) and then, after an initial period of ventilation, they will be ventilated with the other technique. Ventilation then will be optimized by an expert and the two modes of ventilation will be repeated in succession.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>All the patients will be ventilated in both modes.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Improvement of synchrony in nPSV v.s PSV</measure>
      <time_frame>last 2 minutes over 30 minutes registration</time_frame>
      <description>Synchrony time [Timesych]: time frame during which both the ventilator and the neural patient inspiratory time are in the inspiratory phase (s)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Respiratory pattern in nPSV vs PSV</measure>
      <time_frame>last 2 minutes over 30 minutes registration</time_frame>
      <description>Tidal Volume (ml)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory pattern in nPSV vs PSV</measure>
      <time_frame>last 2 minutes over 30 minutes registration</time_frame>
      <description>Minute Volume Ventilation (L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory pattern in nPSV vs PSV</measure>
      <time_frame>last 2 minutes over 30 minutes registration</time_frame>
      <description>Respiratory Rate (Breath per minute)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory pattern in nPSV vs PSV</measure>
      <time_frame>last 2 minutes over 30 minutes registration</time_frame>
      <description>Inspiratory Time [Ti] (s)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory pattern in nPSV vs PSV</measure>
      <time_frame>last 2 minutes over 30 minutes registration</time_frame>
      <description>Neural Inspiratory Time [Tineu] (s)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Ventilator Synchrony in nPSV vs PSV</measure>
      <time_frame>last 2 minutes over 30 minutes registration</time_frame>
      <description>Inspiratory Neural-Ventilator Coupling [NCVi] (Percentage)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory pattern in nPSV vs PSV</measure>
      <time_frame>last 2 minutes over 30 minutes registration</time_frame>
      <description>Peak of Electrical Activity of the diaphragm [EAdi peak] (mcV)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Ventilator Synchrony in nPSV vs PSV</measure>
      <time_frame>last 2 minutes over 30 minutes registration</time_frame>
      <description>Asynchrony Index (AI): ratio between the number of ineffective efforts, auto-triggers and double triggers and the neural respiratory rate plus auto-triggers (percentage)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Blood gas analisys</measure>
      <time_frame>At the end of each 30-minutes trial</time_frame>
      <description>pH (-log10H+)</description>
    </other_outcome>
    <other_outcome>
      <measure>Blood gas analisys</measure>
      <time_frame>At the end of each 30-minutes trial</time_frame>
      <description>Arterial Oxygen Partial Pressure [PaO2] (mmHg)</description>
    </other_outcome>
    <other_outcome>
      <measure>Blood gas analisys</measure>
      <time_frame>At the end of each 30-minutes trial</time_frame>
      <description>Arterial Carbon Dioxide Partial Pressure [PaCO2] (mmHg)</description>
    </other_outcome>
    <other_outcome>
      <measure>Blood gas analisys</measure>
      <time_frame>At the end of each 30-minutes trial</time_frame>
      <description>Sodium Bicarbonate [HCO3-] (mEq/L)</description>
    </other_outcome>
    <other_outcome>
      <measure>Blood gas analisys</measure>
      <time_frame>At the end of each 30-minutes trial</time_frame>
      <description>Lactate [Lac] (mmol/L)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">24</enrollment>
    <condition>Respiratory Failure</condition>
    <condition>Mechanical Ventilation Complication</condition>
    <arm_group>
      <arm_group_label>nPSV first</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will follow the pattern: nPSV -&gt; PSV -&gt; nPSVo -&gt; PSVo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PSV first</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will follow the pattern: PSV -&gt; nPSV -&gt; PSVo -&gt; nPSVo</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>nPSV and PSV</intervention_name>
      <description>Ventilation with neurally adjusted modes or pressure support modes</description>
      <arm_group_label>PSV first</arm_group_label>
      <arm_group_label>nPSV first</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients (&gt;18aa)&#xD;
  &#xD;
            -  Non Invasive Ventilation with helmet&#xD;
  &#xD;
            -  NG tubing for clinical use in position&#xD;
  &#xD;
            -  Invasive arterial monitoring for clinical use in position&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to express consent&#xD;
  &#xD;
            -  Expected NIV &lt; 24hrs&#xD;
  &#xD;
            -  Gastric-esophageal surgery in the preceding 12 months&#xD;
  &#xD;
            -  Upper-GI bleeding in the last 30 days&#xD;
  &#xD;
            -  History of esophageal varices&#xD;
  &#xD;
            -  Recent trauma or facial surgery&#xD;
  &#xD;
            -  Haemodinamic instability even a after liquid infusion (need of at least dopamine &gt;5&#xD;
               γ/kg/min or norephinephrine &gt;0.1 γ/kg min to obtain systolic pressure &gt;90 mmHg)&#xD;
  &#xD;
            -  Core temperature &gt;30C°&#xD;
  &#xD;
            -  Coagulation disorders (INR &gt; 1.5 and/or aPTT &gt;44 sec)&#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>Davide Colombo, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>ASL Novara</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>SS. Trinità Hospital</name>
        <address>
          <city>Borgomanero</city>
          <state>Novara</state>
          <zip>28021</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <results_reference>
      <citation>Evans TW. International Consensus Conferences in Intensive Care Medicine: non-invasive positive pressure ventilation in acute respiratory failure. Organised jointly by the American Thoracic Society, the European Respiratory Society, the European Society of Intensive Care Medicine, and the Societe de Reanimation de Langue Francaise, and approved by the ATS Board of Directors, December 2000. Intensive Care Med. 2001 Jan;27(1):166-78. doi: 10.1007/s001340000721. No abstract available.</citation>
      <PMID>11280630</PMID>
    </results_reference>
    <results_reference>
      <citation>Squadrone E, Frigerio P, Fogliati C, Gregoretti C, Conti G, Antonelli M, Costa R, Baiardi P, Navalesi P. Noninvasive vs invasive ventilation in COPD patients with severe acute respiratory failure deemed to require ventilatory assistance. Intensive Care Med. 2004 Jul;30(7):1303-10. doi: 10.1007/s00134-004-2320-7. Epub 2004 Jun 12.</citation>
      <PMID>15197438</PMID>
    </results_reference>
    <results_reference>
      <citation>Vignaux L, Vargas F, Roeseler J, Tassaux D, Thille AW, Kossowsky MP, Brochard L, Jolliet P. Patient-ventilator asynchrony during non-invasive ventilation for acute respiratory failure: a multicenter study. Intensive Care Med. 2009 May;35(5):840-6. doi: 10.1007/s00134-009-1416-5. Epub 2009 Jan 29.</citation>
      <PMID>19183949</PMID>
    </results_reference>
    <results_reference>
      <citation>Navalesi P, Costa R, Ceriana P, Carlucci A, Prinianakis G, Antonelli M, Conti G, Nava S. Non-invasive ventilation in chronic obstructive pulmonary disease patients: helmet versus facial mask. Intensive Care Med. 2007 Jan;33(1):74-81. doi: 10.1007/s00134-006-0391-3. Epub 2006 Oct 13.</citation>
      <PMID>17039354</PMID>
    </results_reference>
    <results_reference>
      <citation>Colombo D, Cammarota G, Bergamaschi V, De Lucia M, Corte FD, Navalesi P. Physiologic response to varying levels of pressure support and neurally adjusted ventilatory assist in patients with acute respiratory failure. Intensive Care Med. 2008 Nov;34(11):2010-8. doi: 10.1007/s00134-008-1208-3. Epub 2008 Jul 16.</citation>
      <PMID>18629471</PMID>
    </results_reference>
    <results_reference>
      <citation>Muttini S, Villani PG, Trimarco R, Bellani G, Grasselli G, Patroniti N. Relation between peak and integral of the diaphragm electromyographic activity at different levels of support during weaning from mechanical ventilation: a physiologic study. J Crit Care. 2015 Feb;30(1):7-12. doi: 10.1016/j.jcrc.2014.08.013. Epub 2014 Aug 28.</citation>
      <PMID>25239821</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>ASL Novara</investigator_affiliation>
      <investigator_full_name>Davide Colombo</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <keyword>Mechanical Ventilation</keyword>
    <keyword>Non Invasive Ventilation</keyword>
    <keyword>Weaning</keyword>
    <keyword>Neurally Adjusted Ventilator Assist</keyword>
    <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>No</sharing_ipd>
    </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/NCT06004206
  org study id: NiVnPSV
  nct id: NCT06004206
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to evaluate if neural pressure support ventilation is able
        to improve patient-ventilator synchrony, in ICU patients undergoing non-invasive ventilation
        (NIV). The main question it aims to answer is:
  
        • Is neural pressure support ventilation better than the pressure support ventilation with
        respect to patient-ventilator synchrony during helmet NIV?
  
        Researchers will compare neural pressure support ventilation versus pressure support
        ventilation (Gold standard assisted mode in Europe) to see if the new mode improve
        patient-ventilator synchrony.
  Non-Invasive Ventilation (NIV) has found many different uses in clinical settings, shortening
        intubation times and preventing orotracheal intubation. NIV success is highly affected by
        patient comfort and patient-ventilator synchrony. The helmet is one of the most comfortable
        interfaces, even if synchrony is low due to dead space. The use of Neurally Adjusted
        Ventilatory Assist (NAVA), in which the Electrical Activity of the Diaphragm (EAdi) drives
        the ventilator, has shown improvement in comfort and synchrony but still some limitation with
        helmet, due to the long pressurization time. Pressure-Support Ventilation (PSV) is still the
        most used and diffused assisted mode in Europe due to its simplicity and effectiveness in
        helmet-NIV. The aim of this study is to test a new ventilation software called Neural
        Pressure Support Ventilation (nPSV), which merges the rapid pressurization of PSV along with
        the EAdi trigger, onto a population of 24 critical care patients ventilated with a helmet
        NIV.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Patients will be ventilated in nPSV or PSV (according to randomization) and then, after an initial period of ventilation, they will be ventilated with the other technique. Ventilation then will be optimized by an expert and the two modes of ventilation will be repeated in succession.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: All the patients will be ventilated in both modes.
  measure: Improvement of synchrony in nPSV v.s PSV
  time frame: last 2 minutes over 30 minutes registration
  description: Synchrony time [Timesych]: time frame during which both the ventilator and the neural patient inspiratory time are in the inspiratory phase (s)
  measure: Respiratory pattern in nPSV vs PSV
  time frame: last 2 minutes over 30 minutes registration
  description: Tidal Volume (ml)
  measure: Respiratory pattern in nPSV vs PSV
  time frame: last 2 minutes over 30 minutes registration
  description: Minute Volume Ventilation (L)
  measure: Respiratory pattern in nPSV vs PSV
  time frame: last 2 minutes over 30 minutes registration
  description: Respiratory Rate (Breath per minute)
  measure: Respiratory pattern in nPSV vs PSV
  time frame: last 2 minutes over 30 minutes registration
  description: Inspiratory Time [Ti] (s)
  measure: Respiratory pattern in nPSV vs PSV
  time frame: last 2 minutes over 30 minutes registration
  description: Neural Inspiratory Time [Tineu] (s)
  measure: Patient Ventilator Synchrony in nPSV vs PSV
  time frame: last 2 minutes over 30 minutes registration
  description: Inspiratory Neural-Ventilator Coupling [NCVi] (Percentage)
  measure: Respiratory pattern in nPSV vs PSV
  time frame: last 2 minutes over 30 minutes registration
  description: Peak of Electrical Activity of the diaphragm [EAdi peak] (mcV)
  measure: Patient Ventilator Synchrony in nPSV vs PSV
  time frame: last 2 minutes over 30 minutes registration
  description: Asynchrony Index (AI): ratio between the number of ineffective efforts, auto-triggers and double triggers and the neural respiratory rate plus auto-triggers (percentage)
  measure: Blood gas analisys
  time frame: At the end of each 30-minutes trial
  description: pH (-log10H+)
  measure: Blood gas analisys
  time frame: At the end of each 30-minutes trial
  description: Arterial Oxygen Partial Pressure [PaO2] (mmHg)
  measure: Blood gas analisys
  time frame: At the end of each 30-minutes trial
  description: Arterial Carbon Dioxide Partial Pressure [PaCO2] (mmHg)
  measure: Blood gas analisys
  time frame: At the end of each 30-minutes trial
  description: Sodium Bicarbonate [HCO3-] (mEq/L)
  measure: Blood gas analisys
  time frame: At the end of each 30-minutes trial
  description: Lactate [Lac] (mmol/L)
  arm group label: nPSV first
  arm group type: Experimental
  description: Patients will follow the pattern: nPSV -> PSV -> nPSVo -> PSVo
  arm group label: PSV first
  arm group type: Experimental
  description: Patients will follow the pattern: PSV -> nPSV -> PSVo -> nPSVo
  intervention type: Device
  intervention name: nPSV and PSV
  description: Ventilation with neurally adjusted modes or pressure support modes
  arm group label: PSV first
  arm group label: nPSV first
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Davide Colombo, MD, PhD
  role: Study Chair
  affiliation: ASL Novara
  facility: 
  country: Italy
  citation: Evans TW. International Consensus Conferences in Intensive Care Medicine: non-invasive positive pressure ventilation in acute respiratory failure. Organised jointly by the American Thoracic Society, the European Respiratory Society, the European Society of Intensive Care Medicine, and the Societe de Reanimation de Langue Francaise, and approved by the ATS Board of Directors, December 2000. Intensive Care Med. 2001 Jan;27(1):166-78. doi: 10.1007/s001340000721. No abstract available.
  PMID: 11280630
  citation: Squadrone E, Frigerio P, Fogliati C, Gregoretti C, Conti G, Antonelli M, Costa R, Baiardi P, Navalesi P. Noninvasive vs invasive ventilation in COPD patients with severe acute respiratory failure deemed to require ventilatory assistance. Intensive Care Med. 2004 Jul;30(7):1303-10. doi: 10.1007/s00134-004-2320-7. Epub 2004 Jun 12.
  PMID: 15197438
  citation: Vignaux L, Vargas F, Roeseler J, Tassaux D, Thille AW, Kossowsky MP, Brochard L, Jolliet P. Patient-ventilator asynchrony during non-invasive ventilation for acute respiratory failure: a multicenter study. Intensive Care Med. 2009 May;35(5):840-6. doi: 10.1007/s00134-009-1416-5. Epub 2009 Jan 29.
  PMID: 19183949
  citation: Navalesi P, Costa R, Ceriana P, Carlucci A, Prinianakis G, Antonelli M, Conti G, Nava S. Non-invasive ventilation in chronic obstructive pulmonary disease patients: helmet versus facial mask. Intensive Care Med. 2007 Jan;33(1):74-81. doi: 10.1007/s00134-006-0391-3. Epub 2006 Oct 13.
  PMID: 17039354
  citation: Colombo D, Cammarota G, Bergamaschi V, De Lucia M, Corte FD, Navalesi P. Physiologic response to varying levels of pressure support and neurally adjusted ventilatory assist in patients with acute respiratory failure. Intensive Care Med. 2008 Nov;34(11):2010-8. doi: 10.1007/s00134-008-1208-3. Epub 2008 Jul 16.
  PMID: 18629471
  citation: Muttini S, Villani PG, Trimarco R, Bellani G, Grasselli G, Patroniti N. Relation between peak and integral of the diaphragm electromyographic activity at different levels of support during weaning from mechanical ventilation: a physiologic study. J Crit Care. 2015 Feb;30(1):7-12. doi: 10.1016/j.jcrc.2014.08.013. Epub 2014 Aug 28.
  PMID: 25239821
  responsible party type: Principal Investigator
  investigator affiliation: ASL Novara
  investigator full name: Davide Colombo
  investigator title: Doctor
  mesh term: Respiratory Insufficiency
  sharing ipd: No