<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/NCT02976233</url>
  </required_header>
  <id_info>
    <org_study_id>ECONIV</org_study_id>
    <nct_id>NCT02976233</nct_id>
  </id_info>
  <brief_title>Diaphragmatic Ultrasound to Predict NIV Outcome in Patients With De-novo ARF</brief_title>
  <official_title>Measuring Diaphragm Thickening Using Ultrasonography to Predict NIV Outcome in Patients With De-novo ARF Admitted to the Emergency Department</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over the last two decades, non-invasive ventilation (NIV) has been widely reported as an&#xD;
      effective method to avoid the need of endotracheal intubation (ETI) and improve survival in&#xD;
      the acute care setting. Given the risks associated with either premature NIV discontinuation&#xD;
      or delays in NIV interruption, evaluating readiness to weaning from NIV is a critical&#xD;
      challenge in patients with Acute Respiratory Failure (ARF).&#xD;
&#xD;
      Up to date, bedside measurements used to predict NIV outcomes are extremely limited. NIV&#xD;
      weaning as well as decision of ETI are mainly supported by clinical and physiologic&#xD;
      parameters. More sophisticated techniques used to predict weaning outcome during spontaneous&#xD;
      breathing trials have never achieved a bedside broad-spectrum use due to their invasiveness,&#xD;
      the inconsistent results in demonstrating reproducible outcomes, the requirements of&#xD;
      additional trainee personnel and complicated equipment, and the difficult application in&#xD;
      awake and non-intubated patients.&#xD;
&#xD;
      Recently, ultrasound has been used for the rapid assessment of diaphragm function in acutely&#xD;
      ill patients. The advantages of the ultrasound in detecting diaphragm dysfunction as compared&#xD;
      with other techniques are the less invasiveness, the avoidance of radiation hazards and the&#xD;
      bedside feasibility. Direct imaging of changes in diaphragm thickening (DT) during&#xD;
      spontaneous breathing may provide the assessment of both the muscle and the respiratory pump&#xD;
      functioning. Indeed, DT has been correlated with the diaphragm strength and the muscle&#xD;
      shortening. The volume of diaphragm muscle mass remains constant while it contracts.&#xD;
      Consequently, as the muscle shortens it thickens itself and measurements of changes in such a&#xD;
      thickening (DT) are inversely related to changes in diaphragm length. Studies in patients&#xD;
      with diaphragm paralysis have confirmed the absence of DT. Moreover, since the diaphragm is&#xD;
      the major muscle of inspiration, the presence of diaphragm shortening and contraction may&#xD;
      predict successful extubation in patients who are invasively ventilated.&#xD;
&#xD;
      The aim of the present study is to assess whether DT as measured by ultrasound may predict&#xD;
      NIV outcome in patients with de-novo ARF admitted to the Emergency Department (ED).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All consecutive patients with de-novo ARF requiring NIV treatment while they will be admitted&#xD;
      to the Emergency Department at Gemelli's Hospital, Rome-Italy will be included into the&#xD;
      present study.&#xD;
&#xD;
      The present protocol will be approved by the local Ethics Committee and informed consent will&#xD;
      be obtained by the all study participants or their next of kin.&#xD;
&#xD;
      All the patients will be ventilated in the ED over a maximum of 48 hours, by using 2 types of&#xD;
      different ventilators (Evita XL, Drager or Infinity C500, Drager).&#xD;
&#xD;
      In all patients NIV will be delivered through either a facial mask with an inflatable soft&#xD;
      cushion seal (Gibeck, Upplands, Sweden; Vitalsigns, Towota, NJ, USA) or to a clear,&#xD;
      latex-free helmet (CaStar, Starmed, Mirandola, Italy), according to the clinical decision.&#xD;
&#xD;
      Pressure support ventilation with positive end-expiratory pressure (PEEP) will be used with&#xD;
      all interfaces. Pressure support ventilation will be started at 10 cmH2O and increased with&#xD;
      progressive stepwise increments of 2-3 cmH2O, to obtain an exhaled tidal volume of 6 mL/kg, a&#xD;
      respiratory rate (RR) &lt; 25 breaths/min, patient comfort and disappearance of both accessory&#xD;
      muscle activity and/or paradoxical abdominal motion. PEEP will be increased with stepwise&#xD;
      increments of 2-3 cmH2O up to 12 cmH2O to ensure peripheral oxygen saturation (SpO2) of ≥90%&#xD;
      with the lowest possible FiO2. When the helmet will be used, part of the volume delivered to&#xD;
      the system will be used to distend the helmet without reaching the patient. PEEP levels will&#xD;
      be increased with stepwise increments of 2-3 cmH2O up to 15-18 cmH2O to ensure peripheral&#xD;
      oxygen saturation (SpO2) of ≥90% with the lowest possible FiO2 during NIV delivered through&#xD;
      the helmet. Ventilator settings will be then adjusted according to SpO2 and measurements of&#xD;
      arterial blood gases. The flow trigger will be set at 3 L/s, checking out the absence of&#xD;
      auto-triggering phenomena.&#xD;
&#xD;
      All study group will be managed according to the standard of care with respect of medical&#xD;
      management of ARF (i.e, antibiotic, antiviral, or antifungal agents; bronchodilators;&#xD;
      diuretics; frequent respiratory treatments and chest physiotherapy), timing of medical&#xD;
      interventions (i.e placement of central and arterial catheters and frequency of blood&#xD;
      withdrawals, and cultures) and other aspects of emergency support (fluid administration,&#xD;
      correction of electrolytes abnormalities, nutrition).&#xD;
&#xD;
      All the patients will be kept with the head of the bed at 30-45 degrees.&#xD;
&#xD;
      Criteria for intubation and NIV discontinuation Pre-determined criteria for immediate ETI&#xD;
      will include the inability to maintain a PaO2 /FIO2 &gt; 140 during NIV, the onset of seizures&#xD;
      or coma (Glasgow coma score &lt; 8), hemodynamic instability (systolic blood pressure &lt; 80 mmHg&#xD;
      despite adequate fluid resuscitation and/or electrocardiographic signs of ischemia or&#xD;
      arrhythmias), intolerance of the interface, inability to manage copious secretions, inability&#xD;
      to alleviate dyspnea, or the need for an emergency surgical procedure. After intubation, all&#xD;
      patients will be ventilated with the same ventilation protocol, according to the&#xD;
      low-tidal-volume protective ventilatory strategy.&#xD;
&#xD;
      Criteria for NIV weaning NIV will be maintained over the next 48 hours until oxygenation and&#xD;
      clinical status will improve. NIV will be progressively reduced in accordance with the degree&#xD;
      of clinical improvement and discontinued if the patient will be able to maintain a&#xD;
      respiratory rate &lt; than 30 breaths/min and a PaO2 &gt; 75 mmHg with a FiO2 of 0.5 without&#xD;
      ventilatory support.&#xD;
&#xD;
      Definitions and Measurements The Simplified Acute Physiologic Score (SAPS II) will be&#xD;
      calculated on admission to the study.&#xD;
&#xD;
      For all study group, the duration of mechanical ventilation and the ED stay, as well as the&#xD;
      hospital outcome will be registered.&#xD;
&#xD;
      During the first 12 hours from the enrollment into the study, the arterial blood gas levels&#xD;
      will be determined at baseline, at 1 hour, at 4 and 12 hours. Following this period, the&#xD;
      parameters will be measured at 12 hour intervals until the 96th hour from the patient&#xD;
      admission and/or his discharge.&#xD;
&#xD;
      Improvement in gas exchange will be defined as the ability to increase PaO2/FiO2 above 200 or&#xD;
      an increase in this ratio of more than 100 from baseline.&#xD;
&#xD;
      Early NIV success will be defined as the improvement in clinical status and gas exchange&#xD;
      within 1 hour of treatment.&#xD;
&#xD;
      NIV success will be defined as the improvement in clinical status and gas exchange within the&#xD;
      first 48 hours of treatment.&#xD;
&#xD;
      Sustained NIV success will be defined as the ability to maintain the defined improvement in&#xD;
      clinical status and gas exchange over the next 48 hours after the end of the time needed to&#xD;
      define NIV success.&#xD;
&#xD;
      NIV failure will be defined as the need of ETI at any point of the study period and/or&#xD;
      failure to reach an improvement in clinical status and gas exchange within 48 hours.&#xD;
&#xD;
      Patients will be monitored for the development of infections or other complications. Sepsis,&#xD;
      severe sepsis, and septic shock will be defined according to recent consensus guidelines.&#xD;
      Adult respiratory distress syndrome (ARDS) will be defined according to the Berlin&#xD;
      definition.&#xD;
&#xD;
      Diaphragm thickness (DT) will be measured using a 7-10 MHz linear ultrasound probe set to B&#xD;
      mode (Vividier, General Electrics). Both the right and left diaphragm will be imaged at the&#xD;
      apposition point of the diaphragm and the rib cage on the midaxillary line, between the 8th&#xD;
      and the 10th intercostal spaces. DT will be measured at either the end-expiration or the&#xD;
      end-inspiration. The percent change in DT between end-expiration and end-inspiration (ΔDT%)&#xD;
      will be calculated as [(DTend-inspiration-DTend-expiration/DTend-expiration)×100]. The ΔDT%&#xD;
      for each patient will represent the mean of three to five breaths. During the first 12 hours&#xD;
      from the enrollment into the study, the DTF measurements will be determined at baseline, at 1&#xD;
      hour, at 4 and 12 hours. Following this period, the measurements will be performed at 12 hour&#xD;
      intervals until the 96th hour from the patient admission and/or his discharge.&#xD;
&#xD;
      Training the ultrasound operator to identify the diaphragm and measure its thickness will&#xD;
      take from three to five sessions.&#xD;
&#xD;
      Measurements will be performed by 2 different and appropriately trained operators who are&#xD;
      routinely involved in the management of the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Ultrasound Diaphragmayic Thickening to predict NIV outcome in patients with de-novo ARF</measure>
    <time_frame>96 hours</time_frame>
    <description>Diaphragm thicknening (DT) will be measured using a 7-10 MHz linear ultrasound probe set to B mode (Vividier, General Electrics). Both the right and left diaphragm will be imaged at the apposition point of the diaphragm and the rib cage on the midaxillary line, between the 8th and the 10th intercostal spaces. DT will be measured at either the end-expiration or the end-inspiration. The percent change in DT between end-expiration and end-inspiration (ΔDT%) will be calculated as [(DTend-inspiration-DTend-expiration/DTend-expiration)×100]. The ΔDT% for each patient will represent the mean of three to five breaths. Measurements will be performed by 2 different and appropriately trained operators who are routinely involved in the management of the patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Mechanical Ventilation (MV) and Emergency Department (ED) stay as well as hospital outcome.</measure>
    <time_frame>96 hours for the duration of MV and the ED stay+ 1 year for hospital outcome</time_frame>
    <description>NIV will be progressively reduced in accordance with the degree of clinical improvement and discontinued if the patient will be able to maintain a respiratory rate &lt; than 30 breaths/min and a PaO2 &gt; 75 mmHg with a FiO2 of 0.5 without ventilatory support. The duration of mechanical ventilation and the</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Acute Respiratory Failure in NIV</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients with de-novo ARF requiring NIV treatment while they will be&#xD;
        admitted to the Emergency Department at Gemelli's Hospital, Rome-Italy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Respiratory rate &gt; 35 breaths/min,&#xD;
&#xD;
          -  PaO2/FiO2 &lt; 200 while the patient is breathing oxygen through a Venturi mask and&#xD;
             active contraction of the accessory muscles of respiration or paradoxical abdominal&#xD;
             motion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years,&#xD;
&#xD;
          -  Pregnancy,&#xD;
&#xD;
          -  Diaphragm paralysis,&#xD;
&#xD;
          -  Neuromuscular disorders,&#xD;
&#xD;
          -  Palliative NIV in patients with malignancy,&#xD;
&#xD;
          -  Ineffective cough,&#xD;
&#xD;
          -  Inability to protect airways.&#xD;
&#xD;
          -  BMI &gt; 35&#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>Giovanna Mercurio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione Policlinico Agostino Gemelli Rome, Department of Anesthesia and Intensive Care Unit</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Temistocle Taccheri, MD</last_name>
    <phone>3470526726</phone>
    <phone_ext>+39</phone_ext>
    <email>taccheri.temistocle@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Simone Carelli, MD</last_name>
    <phone>3407465537</phone>
    <phone_ext>+39</phone_ext>
    <email>simonecarelli.sc@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Intensive Care Unit Policlinico A. Gemelli</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giovanna Mercurio, MD</last_name>
      <phone>3313032842</phone>
      <phone_ext>+31</phone_ext>
      <email>giovimercurio@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Simone Carelli, MD</last_name>
      <phone>3407465537</phone>
      <phone_ext>+39</phone_ext>
      <email>simonecarelli.sc@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Temistocle Taccheri, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Davide Eleuteri, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sonia D'Arrigo, Md</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 24, 2016</last_update_submitted>
  <last_update_submitted_qc>November 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</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>Dr.ssa Mercurio</investigator_full_name>
    <investigator_title>MD of Department of Anesthesia and Intensive Care , Policlinico A. Gemelli , Catholic University of the Sacred Heart in Rome</investigator_title>
  </responsible_party>
  <keyword>Acute Respiratory Failure</keyword>
  <keyword>Non Invasive Ventilation</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Diaphragm Thickening</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>


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/NCT02976233
org study id: ECONIV
nct id: NCT02976233
lead sponsor: 
has dmc: No
Over the last two decades, non-invasive ventilation (NIV) has been widely reported as an
      effective method to avoid the need of endotracheal intubation (ETI) and improve survival in
      the acute care setting. Given the risks associated with either premature NIV discontinuation
      or delays in NIV interruption, evaluating readiness to weaning from NIV is a critical
      challenge in patients with Acute Respiratory Failure (ARF).

      Up to date, bedside measurements used to predict NIV outcomes are extremely limited. NIV
      weaning as well as decision of ETI are mainly supported by clinical and physiologic
      parameters. More sophisticated techniques used to predict weaning outcome during spontaneous
      breathing trials have never achieved a bedside broad-spectrum use due to their invasiveness,
      the inconsistent results in demonstrating reproducible outcomes, the requirements of
      additional trainee personnel and complicated equipment, and the difficult application in
      awake and non-intubated patients.

      Recently, ultrasound has been used for the rapid assessment of diaphragm function in acutely
      ill patients. The advantages of the ultrasound in detecting diaphragm dysfunction as compared
      with other techniques are the less invasiveness, the avoidance of radiation hazards and the
      bedside feasibility. Direct imaging of changes in diaphragm thickening (DT) during
      spontaneous breathing may provide the assessment of both the muscle and the respiratory pump
      functioning. Indeed, DT has been correlated with the diaphragm strength and the muscle
      shortening. The volume of diaphragm muscle mass remains constant while it contracts.
      Consequently, as the muscle shortens it thickens itself and measurements of changes in such a
      thickening (DT) are inversely related to changes in diaphragm length. Studies in patients
      with diaphragm paralysis have confirmed the absence of DT. Moreover, since the diaphragm is
      the major muscle of inspiration, the presence of diaphragm shortening and contraction may
      predict successful extubation in patients who are invasively ventilated.

      The aim of the present study is to assess whether DT as measured by ultrasound may predict
      NIV outcome in patients with de-novo ARF admitted to the Emergency Department (ED).
All consecutive patients with de-novo ARF requiring NIV treatment while they will be admitted
      to the Emergency Department at Gemelli's Hospital, Rome-Italy will be included into the
      present study.

      The present protocol will be approved by the local Ethics Committee and informed consent will
      be obtained by the all study participants or their next of kin.

      All the patients will be ventilated in the ED over a maximum of 48 hours, by using 2 types of
      different ventilators (Evita XL, Drager or Infinity C500, Drager).

      In all patients NIV will be delivered through either a facial mask with an inflatable soft
      cushion seal (Gibeck, Upplands, Sweden; Vitalsigns, Towota, NJ, USA) or to a clear,
      latex-free helmet (CaStar, Starmed, Mirandola, Italy), according to the clinical decision.

      Pressure support ventilation with positive end-expiratory pressure (PEEP) will be used with
      all interfaces. Pressure support ventilation will be started at 10 cmH2O and increased with
      progressive stepwise increments of 2-3 cmH2O, to obtain an exhaled tidal volume of 6 mL/kg, a
      respiratory rate (RR) < 25 breaths/min, patient comfort and disappearance of both accessory
      muscle activity and/or paradoxical abdominal motion. PEEP will be increased with stepwise
      increments of 2-3 cmH2O up to 12 cmH2O to ensure peripheral oxygen saturation (SpO2) of ≥90%
      with the lowest possible FiO2. When the helmet will be used, part of the volume delivered to
      the system will be used to distend the helmet without reaching the patient. PEEP levels will
      be increased with stepwise increments of 2-3 cmH2O up to 15-18 cmH2O to ensure peripheral
      oxygen saturation (SpO2) of ≥90% with the lowest possible FiO2 during NIV delivered through
      the helmet. Ventilator settings will be then adjusted according to SpO2 and measurements of
      arterial blood gases. The flow trigger will be set at 3 L/s, checking out the absence of
      auto-triggering phenomena.

      All study group will be managed according to the standard of care with respect of medical
      management of ARF (i.e, antibiotic, antiviral, or antifungal agents; bronchodilators;
      diuretics; frequent respiratory treatments and chest physiotherapy), timing of medical
      interventions (i.e placement of central and arterial catheters and frequency of blood
      withdrawals, and cultures) and other aspects of emergency support (fluid administration,
      correction of electrolytes abnormalities, nutrition).

      All the patients will be kept with the head of the bed at 30-45 degrees.

      Criteria for intubation and NIV discontinuation Pre-determined criteria for immediate ETI
      will include the inability to maintain a PaO2 /FIO2 > 140 during NIV, the onset of seizures
      or coma (Glasgow coma score < 8), hemodynamic instability (systolic blood pressure < 80 mmHg
      despite adequate fluid resuscitation and/or electrocardiographic signs of ischemia or
      arrhythmias), intolerance of the interface, inability to manage copious secretions, inability
      to alleviate dyspnea, or the need for an emergency surgical procedure. After intubation, all
      patients will be ventilated with the same ventilation protocol, according to the
      low-tidal-volume protective ventilatory strategy.

      Criteria for NIV weaning NIV will be maintained over the next 48 hours until oxygenation and
      clinical status will improve. NIV will be progressively reduced in accordance with the degree
      of clinical improvement and discontinued if the patient will be able to maintain a
      respiratory rate < than 30 breaths/min and a PaO2 > 75 mmHg with a FiO2 of 0.5 without
      ventilatory support.

      Definitions and Measurements The Simplified Acute Physiologic Score (SAPS II) will be
      calculated on admission to the study.

      For all study group, the duration of mechanical ventilation and the ED stay, as well as the
      hospital outcome will be registered.

      During the first 12 hours from the enrollment into the study, the arterial blood gas levels
      will be determined at baseline, at 1 hour, at 4 and 12 hours. Following this period, the
      parameters will be measured at 12 hour intervals until the 96th hour from the patient
      admission and/or his discharge.

      Improvement in gas exchange will be defined as the ability to increase PaO2/FiO2 above 200 or
      an increase in this ratio of more than 100 from baseline.

      Early NIV success will be defined as the improvement in clinical status and gas exchange
      within 1 hour of treatment.

      NIV success will be defined as the improvement in clinical status and gas exchange within the
      first 48 hours of treatment.

      Sustained NIV success will be defined as the ability to maintain the defined improvement in
      clinical status and gas exchange over the next 48 hours after the end of the time needed to
      define NIV success.

      NIV failure will be defined as the need of ETI at any point of the study period and/or
      failure to reach an improvement in clinical status and gas exchange within 48 hours.

      Patients will be monitored for the development of infections or other complications. Sepsis,
      severe sepsis, and septic shock will be defined according to recent consensus guidelines.
      Adult respiratory distress syndrome (ARDS) will be defined according to the Berlin
      definition.

      Diaphragm thickness (DT) will be measured using a 7-10 MHz linear ultrasound probe set to B
      mode (Vividier, General Electrics). Both the right and left diaphragm will be imaged at the
      apposition point of the diaphragm and the rib cage on the midaxillary line, between the 8th
      and the 10th intercostal spaces. DT will be measured at either the end-expiration or the
      end-inspiration. The percent change in DT between end-expiration and end-inspiration (ΔDT%)
      will be calculated as [(DTend-inspiration-DTend-expiration/DTend-expiration)×100]. The ΔDT%
      for each patient will represent the mean of three to five breaths. During the first 12 hours
      from the enrollment into the study, the DTF measurements will be determined at baseline, at 1
      hour, at 4 and 12 hours. Following this period, the measurements will be performed at 12 hour
      intervals until the 96th hour from the patient admission and/or his discharge.

      Training the ultrasound operator to identify the diaphragm and measure its thickness will
      take from three to five sessions.

      Measurements will be performed by 2 different and appropriately trained operators who are
      routinely involved in the management of the patients.
observational model: Cohort
time perspective: Prospective
measure: Ultrasound Diaphragmayic Thickening to predict NIV outcome in patients with de-novo ARF
time frame: 96 hours
description: Diaphragm thicknening (DT) will be measured using a 7-10 MHz linear ultrasound probe set to B mode (Vividier, General Electrics). Both the right and left diaphragm will be imaged at the apposition point of the diaphragm and the rib cage on the midaxillary line, between the 8th and the 10th intercostal spaces. DT will be measured at either the end-expiration or the end-inspiration. The percent change in DT between end-expiration and end-inspiration (ΔDT%) will be calculated as [(DTend-inspiration-DTend-expiration/DTend-expiration)×100]. The ΔDT% for each patient will represent the mean of three to five breaths. Measurements will be performed by 2 different and appropriately trained operators who are routinely involved in the management of the patients
measure: Duration of Mechanical Ventilation (MV) and Emergency Department (ED) stay as well as hospital outcome.
time frame: 96 hours for the duration of MV and the ED stay+ 1 year for hospital outcome
description: NIV will be progressively reduced in accordance with the degree of clinical improvement and discontinued if the patient will be able to maintain a respiratory rate < than 30 breaths/min and a PaO2 > 75 mmHg with a FiO2 of 0.5 without ventilatory support. The duration of mechanical ventilation and the
arm group label: Acute Respiratory Failure in NIV
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giovanna Mercurio, MD
role: Principal Investigator
affiliation: Fondazione Policlinico Agostino Gemelli Rome, Department of Anesthesia and Intensive Care Unit
last name: Temistocle Taccheri, MD
phone: 3470526726
phone ext: +39
email: taccheri.temistocle@gmail.com
last name: Simone Carelli, MD
phone: 3407465537
phone ext: +39
email: simonecarelli.sc@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
investigator full name: Dr.ssa Mercurio
investigator title: MD of Department of Anesthesia and Intensive Care , Policlinico A. Gemelli , Catholic University of the Sacred Heart in Rome
mesh term: Respiratory Insufficiency
sharing ipd: No