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/NCT05989139</url>
    </required_header>
    <id_info>
      <org_study_id>5615</org_study_id>
      <nct_id>NCT05989139</nct_id>
    </id_info>
    <brief_title>HF vs NIV in Acute Cardiogenic Pulmonary Edema</brief_title>
    <acronym>HFvsNIV</acronym>
    <official_title>Non-Invasive Ventilation And Right Ventricle Function In Cardiogenic Pulmonary Edema: An Echocardiographic Perspective To Select The Appropriate Ventilatory Support</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study's primary aim is&#xD;
  &#xD;
          -  to compare the effects of two different ventilation modalities, non-invasive&#xD;
             positive-pressure ventilation (NPPV) and high-flow nasal cannulae (HFNC), in the acute&#xD;
             cardiogenic pulmonary edema (ACPE) setting, in terms of echocardiographic parameters of&#xD;
             RV systolic and RV strain.&#xD;
  &#xD;
          -  to determine the differences of the two interventions on other hemodynamic parameters&#xD;
             echocardiographically assessed.&#xD;
  &#xD;
          -  to assess the differences between the two interventions on physiological parameters,&#xD;
             i.e., mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen&#xD;
             saturation (SpO2), and on arterial blood gases (ABG) analysis parameters (i.e. relief of&#xD;
             dyspnea and respiratory distress, patient comfort).&#xD;
  &#xD;
        Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over&#xD;
        fashion, for 40 minutes each (time 0, T0 and time 1, T1), followed by clinical and&#xD;
        echocardiographic evaluation&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm</measure>
      <time_frame>T0 (Patient's enrollment time)</time_frame>
      <description>Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value &gt; 16 mm.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm</measure>
      <time_frame>T1 (40 minutes after the first intervention has started)</time_frame>
      <description>Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value &gt; 16 mm.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm</measure>
      <time_frame>T2 (40 minutes after the second intervention has started)</time_frame>
      <description>Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value &gt; 16 mm.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RV systolic function: RV fractional area change (RVFAC), %</measure>
      <time_frame>T0 (Patient's enrollment time)</time_frame>
      <description>RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value &gt; 35%.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RV systolic function: RV fractional area change (RVFAC), %</measure>
      <time_frame>T1 (40 minutes after the first intervention has started)</time_frame>
      <description>RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value &gt; 35%.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RV systolic function: RV fractional area change (RVFAC), %</measure>
      <time_frame>T2 (40 minutes after the second intervention has started)</time_frame>
      <description>RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value &gt; 35%.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RV systolic function: RV Global Longitudinal strain (GLS), %</measure>
      <time_frame>T0 (Patient's enrollment time)</time_frame>
      <description>RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length [L0] (%).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RV systolic function: RV Global Longitudinal strain (GLS), %</measure>
      <time_frame>T1 (40 minutes after the first intervention has started)</time_frame>
      <description>RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length [L0] (%).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RV systolic function: RV Global Longitudinal strain (GLS), %</measure>
      <time_frame>T2 (40 minutes after the second intervention has started)</time_frame>
      <description>RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length [L0] (%).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>LV systolic function: Left Ventricle Ejection Fraction (LV EF), %</measure>
      <time_frame>T0 (Patient's enrollment time)</time_frame>
      <description>Parameter of LV systolic function Normal value &gt; 50%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LV systolic function: Left Ventricle Ejection Fraction (LV EF), %</measure>
      <time_frame>T1 (40 minutes after the first intervention has started)</time_frame>
      <description>Parameter of LV systolic function Normal value &gt; 50%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LV systolic function: Left Ventricle Ejection Fraction (LV EF), %</measure>
      <time_frame>T2 (40 minutes after the second intervention has started)</time_frame>
      <description>Parameter of LV systolic function Normal value &gt; 50%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LV diastolic function parameter, i.e. LV average E/E' ratio</measure>
      <time_frame>T0 (Patient's enrollment time)</time_frame>
      <description>Parameter able to assess LV diastolic function. E/E' ratio normal value &lt; 12.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LV diastolic function parameter, i.e. LV average E/E' ratio</measure>
      <time_frame>T1 (40 minutes after the first intervention has started)</time_frame>
      <description>Parameter able to assess LV diastolic function. E/E' ratio normal value &lt; 12.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LV diastolic function parameter, i.e. LV average E/E' ratio</measure>
      <time_frame>T2 (40 minutes after the second intervention has started)</time_frame>
      <description>Parameter able to assess LV diastolic function. E/E' ratio normal value &lt; 12.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inferior vena cava respiratory variations</measure>
      <time_frame>T0 (Patient's enrollment time)</time_frame>
      <description>Echocardiographic parameter able to assess fluid responsiveness. Normal value &gt;50%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inferior vena cava respiratory variations</measure>
      <time_frame>T1 (40 minutes after the first intervention has started)</time_frame>
      <description>Echocardiographic parameter able to assess fluid responsiveness. Normal value &gt;50%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inferior vena cava respiratory variations</measure>
      <time_frame>T2 (40 minutes after the second intervention has started)</time_frame>
      <description>Echocardiographic parameter able to assess fluid responsiveness. Normal value &gt;50%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physiological parameter: mean arterial pressure (MAP), mmHg</measure>
      <time_frame>T0 (Patient's enrollment time)</time_frame>
      <description>Normal value &gt;65 mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physiological parameter: mean arterial pressure (MAP), mmHg</measure>
      <time_frame>T1 (40 minutes after the first intervention has started)</time_frame>
      <description>Normal value &gt;65 mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physiological parameter: mean arterial pressure (MAP), mmHg</measure>
      <time_frame>T2 (40 minutes after the second intervention has started)</time_frame>
      <description>Normal value &gt;65 mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physiological parameter: oxygen saturation (SpO2), %</measure>
      <time_frame>T0 (Patient's enrollment time)</time_frame>
      <description>Normal value &gt; 90%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physiological parameter: oxygen saturation (SpO2), %</measure>
      <time_frame>T1 (40 minutes after the first intervention has started)</time_frame>
      <description>Normal value &gt; 90%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physiological parameter: oxygen saturation (SpO2), %</measure>
      <time_frame>T2 (40 minutes after the second intervention has started)</time_frame>
      <description>Normal value &gt; 90%</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Pulmonary Edema Cardiac Cause</condition>
    <arm_group>
      <arm_group_label>NPPV</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>non-invasive positive-pressure ventilation arm</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HFNC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>High-flow nasal cannulae arm</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>NPPV/HFNC</intervention_name>
      <description>Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each. NPPV will be delivered through a full-face mask with a FiO2 starting at 100% and then titrated to achieve an SpO2 of 92-98%. Expiratory positive airway pressure (PEEP) will be firstly set to 5 cmH2O and then increased to a maximum of 15 cmH2O based on SpO2. Pressure support (PS) will be set to an initial value of 10 cmH2O and then increased if signs of respiratory distress persisted or worsened to a maximum value of 20 cmH2O. After 40 minutes, patient is shifted to HFNC ventilation support for 40 minutes.&#xD;
  At the end of the protocol, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.</description>
      <arm_group_label>NPPV</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>HFNC/NPPV</intervention_name>
      <description>Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each.&#xD;
  HFNC oxygen therapy will start at a flow rate of 60 L/min and will be gradually decreased by 5 cmH2O at time if the patient experienced discomfort. FiO2 will be started at 100% and then titrated to maintain a peripheral oxygen saturation of 92%-98%. Active heating and humidification were provided using MR850, Fisher and Paykel, with a temperature chamber of 37°C. After 40 minutes, patient is shifted to NPPV ventilation support for 40 minutes At the end of the protocol, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.</description>
      <arm_group_label>HFNC</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 y.o.;&#xD;
  &#xD;
            -  Clinical diagnosis of ACPE in the setting of either AMI, acute myocarditis,&#xD;
               acute/chronic severe mitral/aortic valve regurgitation, severe mitral/aortic stenosis,&#xD;
               acute/chronic HF with rLVEF diagnosed according to European Society of Cardiology&#xD;
               (ESC) guidelines [4];&#xD;
  &#xD;
            -  Hypertensive crisis with systolic blood pressure &gt;200 mmHg;&#xD;
  &#xD;
            -  Other congenital or acquired structural heart disease causing post capillary pulmonary&#xD;
               hypertension or combination of the previous.&#xD;
  &#xD;
            -  Written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 y.o.;&#xD;
  &#xD;
            -  Hypercapnia with respiratory acidosis (PaCO2 &gt; 45 mmHg with pH &lt; 7.35);&#xD;
  &#xD;
            -  History of fever in the previous 4 days;&#xD;
  &#xD;
            -  White blood cell count &gt; 12.000;&#xD;
  &#xD;
            -  Increased procalcitonin serum levels;&#xD;
  &#xD;
            -  Consolidative areas at chest radiograph;&#xD;
  &#xD;
            -  Hypotension (systolic blood pressure &lt; 85 mmHg);&#xD;
  &#xD;
            -  Cardiogenic shock;&#xD;
  &#xD;
            -  Right ventricular (RV) dysfunction;&#xD;
  &#xD;
            -  Previous cardiac surgery,&#xD;
  &#xD;
            -  Glasgow Coma Scale score ≤ 8 points;&#xD;
  &#xD;
            -  Impaired ability to protect the airway from aspiration;&#xD;
  &#xD;
            -  Orotracheal intubation needed due to cardiopulmonary resuscitation maneuvers;&#xD;
  &#xD;
            -  Respiratory arrest;&#xD;
  &#xD;
            -  Severe hemodynamic instability;&#xD;
  &#xD;
            -  Facial trauma, burns, recent facial surgery or facial anatomy which prevents from the&#xD;
               application of the NPPV interface to patient's face.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 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>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
      <investigator_full_name>Sanna Tommaso</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulmonary Edema</mesh_term>
      <mesh_term>Edema</mesh_term>
    </condition_browse>
    <!-- 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/NCT05989139
  org study id: 5615
  nct id: NCT05989139
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study's primary aim is
  
          -  to compare the effects of two different ventilation modalities, non-invasive
             positive-pressure ventilation (NPPV) and high-flow nasal cannulae (HFNC), in the acute
             cardiogenic pulmonary edema (ACPE) setting, in terms of echocardiographic parameters of
             RV systolic and RV strain.
  
          -  to determine the differences of the two interventions on other hemodynamic parameters
             echocardiographically assessed.
  
          -  to assess the differences between the two interventions on physiological parameters,
             i.e., mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen
             saturation (SpO2), and on arterial blood gases (ABG) analysis parameters (i.e. relief of
             dyspnea and respiratory distress, patient comfort).
  
        Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over
        fashion, for 40 minutes each (time 0, T0 and time 1, T1), followed by clinical and
        echocardiographic evaluation
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
  time frame: T0 (Patient's enrollment time)
  description: Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.
  measure: RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
  time frame: T1 (40 minutes after the first intervention has started)
  description: Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.
  measure: RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
  time frame: T2 (40 minutes after the second intervention has started)
  description: Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.
  measure: RV systolic function: RV fractional area change (RVFAC), %
  time frame: T0 (Patient's enrollment time)
  description: RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value > 35%.
  measure: RV systolic function: RV fractional area change (RVFAC), %
  time frame: T1 (40 minutes after the first intervention has started)
  description: RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value > 35%.
  measure: RV systolic function: RV fractional area change (RVFAC), %
  time frame: T2 (40 minutes after the second intervention has started)
  description: RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value > 35%.
  measure: RV systolic function: RV Global Longitudinal strain (GLS), %
  time frame: T0 (Patient's enrollment time)
  description: RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length [L0] (%).
  measure: RV systolic function: RV Global Longitudinal strain (GLS), %
  time frame: T1 (40 minutes after the first intervention has started)
  description: RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length [L0] (%).
  measure: RV systolic function: RV Global Longitudinal strain (GLS), %
  time frame: T2 (40 minutes after the second intervention has started)
  description: RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length [L0] (%).
  measure: LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
  time frame: T0 (Patient's enrollment time)
  description: Parameter of LV systolic function Normal value > 50%
  measure: LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
  time frame: T1 (40 minutes after the first intervention has started)
  description: Parameter of LV systolic function Normal value > 50%
  measure: LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
  time frame: T2 (40 minutes after the second intervention has started)
  description: Parameter of LV systolic function Normal value > 50%
  measure: LV diastolic function parameter, i.e. LV average E/E' ratio
  time frame: T0 (Patient's enrollment time)
  description: Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.
  measure: LV diastolic function parameter, i.e. LV average E/E' ratio
  time frame: T1 (40 minutes after the first intervention has started)
  description: Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.
  measure: LV diastolic function parameter, i.e. LV average E/E' ratio
  time frame: T2 (40 minutes after the second intervention has started)
  description: Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.
  measure: Inferior vena cava respiratory variations
  time frame: T0 (Patient's enrollment time)
  description: Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.
  measure: Inferior vena cava respiratory variations
  time frame: T1 (40 minutes after the first intervention has started)
  description: Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.
  measure: Inferior vena cava respiratory variations
  time frame: T2 (40 minutes after the second intervention has started)
  description: Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.
  measure: Physiological parameter: mean arterial pressure (MAP), mmHg
  time frame: T0 (Patient's enrollment time)
  description: Normal value >65 mmHg
  measure: Physiological parameter: mean arterial pressure (MAP), mmHg
  time frame: T1 (40 minutes after the first intervention has started)
  description: Normal value >65 mmHg
  measure: Physiological parameter: mean arterial pressure (MAP), mmHg
  time frame: T2 (40 minutes after the second intervention has started)
  description: Normal value >65 mmHg
  measure: Physiological parameter: oxygen saturation (SpO2), %
  time frame: T0 (Patient's enrollment time)
  description: Normal value > 90%
  measure: Physiological parameter: oxygen saturation (SpO2), %
  time frame: T1 (40 minutes after the first intervention has started)
  description: Normal value > 90%
  measure: Physiological parameter: oxygen saturation (SpO2), %
  time frame: T2 (40 minutes after the second intervention has started)
  description: Normal value > 90%
  arm group label: NPPV
  arm group type: Experimental
  description: non-invasive positive-pressure ventilation arm
  arm group label: HFNC
  arm group type: Experimental
  description: High-flow nasal cannulae arm
  intervention type: Procedure
  intervention name: NPPV/HFNC
  description: Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each. NPPV will be delivered through a full-face mask with a FiO2 starting at 100% and then titrated to achieve an SpO2 of 92-98%. Expiratory positive airway pressure (PEEP) will be firstly set to 5 cmH2O and then increased to a maximum of 15 cmH2O based on SpO2. Pressure support (PS) will be set to an initial value of 10 cmH2O and then increased if signs of respiratory distress persisted or worsened to a maximum value of 20 cmH2O. After 40 minutes, patient is shifted to HFNC ventilation support for 40 minutes.
  At the end of the protocol, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.
  arm group label: NPPV
  intervention type: Procedure
  intervention name: HFNC/NPPV
  description: Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each.
  HFNC oxygen therapy will start at a flow rate of 60 L/min and will be gradually decreased by 5 cmH2O at time if the patient experienced discomfort. FiO2 will be started at 100% and then titrated to maintain a peripheral oxygen saturation of 92%-98%. Active heating and humidification were provided using MR850, Fisher and Paykel, with a temperature chamber of 37°C. After 40 minutes, patient is shifted to NPPV ventilation support for 40 minutes At the end of the protocol, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.
  arm group label: HFNC
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  investigator full name: Sanna Tommaso
  investigator title: Professor
  mesh term: Pulmonary Edema
  mesh term: Edema