<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/NCT03041402</url>
  </required_header>
  <id_info>
    <org_study_id>Neural PSV during mask NIV</org_study_id>
    <nct_id>NCT03041402</nct_id>
  </id_info>
  <brief_title>New Setting of Neurally Adjusted Ventilatory Assist During Mask Noninvasive Ventilation</brief_title>
  <official_title>New Setting of Neurally Adjusted Ventilatory Assist During Postextubation Prophylactic Noninvasive Ventilation Through a Mask: a Physiologic Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non invasive ventilation (NIV) is generally delivered by pneumatically triggered and&#xD;
      cycled-off Pressure Support (PSP) through a facial mask. Compared to PSP, Neurally Adjusted&#xD;
      Ventilatory Assist (NAVA), which is the only ventilatory mode using a non-pneumatic signal,&#xD;
      i.e., diaphragm electrical activity (EAdi), to trigger and drive ventilator assistance,&#xD;
      improves patient-ventilator interaction. A specific setting to generate neurally controlled&#xD;
      Pressure Support (PSN) was recently proposed for delivering NIV by helmet. The investigators&#xD;
      here compare PSN with PSP and NAVA during NIV by facial mask, with respect to arterial blood&#xD;
      gases (ABGs), patient comfort, and patient-ventilator interaction and synchrony.&#xD;
&#xD;
      Three 30-minute trials of NIV were randomly delivered to 14 patients immediately after&#xD;
      extubation to prevent post-extubation respiratory failure: 1) PSP, with an inspiratory&#xD;
      support ≥8 cmH2O; 2) NAVA, adjusting the NAVA level to achieve a comparable peak EAdi&#xD;
      (EAdipeak) as during PSP; 3) PSN, setting the NAVA level at 15 cmH2O/mcV with an upper airway&#xD;
      pressure (Paw) limit such to obtain the same overall Paw applied during PSP. We assessed&#xD;
      EAdipeak, ABGs, peak inspiratory flow (PIF), time to reach PIF (PIFtime), pressure-time&#xD;
      product of the first 300 (PTP300-index) and 500 (PTP500-index) milliseconds after initiation&#xD;
      of patient effort, patient comfort, inspiratory trigger delay (DelayTR-insp), and the rate of&#xD;
      asynchrony, as assessed by the Asynchrony Index (AI%).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non Invasive Ventilation (NIV) is increasingly used for treatment of Acute Respiratory&#xD;
      Failure (ARF) and is commonly applied through an oral-nasal mask by means of pneumatically&#xD;
      triggered and cycled-off Pressure Support (PSP). Although better tolerated than invasive&#xD;
      mechanical ventilation, NIV is characterized by drawbacks such as poor patient-ventilator&#xD;
      interaction and discomfort, which are major determinants of NIV failure.&#xD;
&#xD;
      In particular, the pneumatic signals, i.e., flow, volume and airway pressure (Paw), are leak&#xD;
      sensitive and frequently cause patient-ventilator asynchrony. The only mode that does not use&#xD;
      pneumatic signals to trigger and drive the ventilator is Neurally Adjusted Ventilator Assist&#xD;
      (NAVA). In fact, with NAVA the ventilator assistance is under control of diaphragm electrical&#xD;
      activity (EAdi), as assessed through an esophageal catheter. As opposed to PSP, NAVA has been&#xD;
      repeatedly shown to improve patient-ventilator interaction and reduce asynchronies, both&#xD;
      during invasive ventilation and NIV. However, NAVA is characterized by a lower rate of&#xD;
      pressurization than PSP.&#xD;
&#xD;
      Very recently, a specific NIV setting to generate a neurally, i.e., EAdi, controlled Pressure&#xD;
      Support (PSN) has been proposed and applied during both invasive ventilation and NIV&#xD;
      delivered via helmet. PSN consists in increasing the user-controlled gain factor (NAVA level)&#xD;
      at maximum, while restraining inspiratory Paw by adjusting on the ventilator the upper&#xD;
      pressure limit.&#xD;
&#xD;
      During NIV delivered through helmets, PSN has been shown, compared to both PSP and NAVA, to&#xD;
      result in better pressurization and triggering performance, which improve patient's comfort&#xD;
      while reducing EAdi, without affecting respiratory rate and arterial blood gases (ABGs). Due&#xD;
      to the different characteristics of helmets and masks, it is unclear whether these advantages&#xD;
      could be extended to NIV delivered by mask. The investigators therefore designed this&#xD;
      physiological study aimed at comparing PSN with PSP and NAVA, with respect to breathing&#xD;
      pattern, respiratory drive, ABGs, pressurization and triggering performance, patient's&#xD;
      comfort and patient-ventilator synchrony.&#xD;
&#xD;
      After patient enrollment, a nasal-gastric feeding tube able to detect EAdi (EAdi catheter,&#xD;
      Maquet Critical Care, Solna, Sweden) was placed and the correct positioning ascertained. The&#xD;
      study was performed using a Servo-I ventilator (Maquet Critical Care, Solna, Sweden) equipped&#xD;
      with a NIV software for air-leaks. The oral-nasal mask was individually selected for each&#xD;
      patients based on the anthropometric characteristics and in order to minimize air leaks and&#xD;
      optimize patient tolerance, among three different models, FreeMotion RT041 Non Vented Full&#xD;
      Face Mask (Fisher and Paykel, Auckland, New Zealand), Ultra Mirage FFM-NV (ResMed, San Diego,&#xD;
      CA, USA) and PerforMax Face Mask (Philips Respironics, Murrysville, PA, USA).&#xD;
&#xD;
      All patients underwent three 30-minute trials in random order: 1) PSP, setting the&#xD;
      inspiratory pressure support ≥8 cmH2O to obtain a tidal volume of 6-8 mL•kg-1 of body weight,&#xD;
      the fastest rate of pressurization (0.0 sec) and I/E cycling at 35% of peak inspiratory flow&#xD;
      (PIF); 2) NAVA, adjusting the NAVA level in order to achieve a comparable peak EAdi&#xD;
      (EAdipeak) as during PSP with a safety Paw upper limit of 30 cmH2O; 3) PSN, setting the NAVA&#xD;
      level at its maximum (i.e; 15 cmH2O/mcV), and an upper Paw limit such to obtain the same&#xD;
      overall Paw applied during PSP. During both NAVA and PSN the trigger sensitivity was set at&#xD;
      0.5 mcV while, the default cycling-off is 70% EAdipeak, as fixed by the manufacturer. PEEP&#xD;
      was set by the attending physicians in a range between 5 and 10 cmH2O, and left unmodified&#xD;
      throughout the whole study period. The inspiratory oxygen fraction (FiO2) was regulated to&#xD;
      obtain peripheral oxygen saturation (SpO2) between 94% and 96%, before starting the protocol,&#xD;
      and kept unmodified throughout the study period.&#xD;
&#xD;
      The three modes of ventilation were applied according to a computer-generated random sequence&#xD;
      using sealed, opaque numbered envelops. The envelopes were kept in the head of nurses' office&#xD;
      in both institutions. The envelope was opened by the nurse in charge of the patient, and the&#xD;
      sequence of modes to be applied communicated to the investigators.&#xD;
&#xD;
      Predefined criteria for protocol interruption were: 1) need for emergency re-intubation; 2)&#xD;
      SpO2 &lt;90%, 3) acute respiratory acidosis, as defined by PaCO2 &gt;50 mmHg and pH &lt;7.30; 3)&#xD;
      inability to expectorate secretions; 4) hemodynamic instability (i.e.; need for continuous&#xD;
      infusion of dopamine or dobutamine &gt;5 µg∙kg-1∙min-1, norepinephrine &gt;0.1 µg∙kg-1∙min-1 or&#xD;
      epinephrine or vasopressin at any dosage to maintain mean arterial blood pressure &gt;60 mmHg);&#xD;
      5) life-threatening arrhythmias or electrocardiographic signs of ischemia; or 6) loss of 2 or&#xD;
      more points of GCS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of ventilator cycling (RRmec)</measure>
    <time_frame>30 minutes within the trial</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>respiratory drive (Peak of Electrical Activity of the Diaphragm)</measure>
    <time_frame>30 minutes within the trial</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>arterial blood gases</measure>
    <time_frame>30 minutes within the trial</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure-time product (PTP) of the first 200 ms from the onset of the ventilator pressurization (PTP200)</measure>
    <time_frame>30 minutes within the trial</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient's comfort through an 11-point Numeric Rating Scale (NRS)</measure>
    <time_frame>30 minutes within the trial</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inspiratory trigger delay (DelayTR-insp), as the time lag between the onset of neural inspiration and ventilator support</measure>
    <time_frame>30 minutes within the trial</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <condition>Mechanical Ventilation Complication</condition>
  <arm_group>
    <arm_group_label>PSP ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PSP, setting the inspiratory pressure support ≥8 cmH2O to obtain a tidal volume of 6-8 mL•kg-1 of body weight, the fastest rate of pressurization (0.0 sec) and I/E cycling at 35% of peak inspiratory flow</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAVA ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NAVA, adjusting the NAVA level in order to achieve a comparable peak EAdi (EAdipeak) as during PSP with a safety Paw upper limit of 30 cmH2O</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PSN ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PSN, setting the NAVA level at its maximum (i.e; 15 cmH2O/mcV), and an upper Paw limit such to obtain the same overall Paw applied during PSP</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PSP</intervention_name>
    <description>PSP, setting the inspiratory pressure support ≥8 cmH2O to obtain a tidal volume of 6-8 mL•kg-1 of body weight, the fastest rate of pressurization (0.0 sec) and I/E cycling at 35% of peak inspiratory flow</description>
    <arm_group_label>NAVA ventilation</arm_group_label>
    <arm_group_label>PSN ventilation</arm_group_label>
    <arm_group_label>PSP ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NAVA</intervention_name>
    <description>NAVA, adjusting the NAVA level in order to achieve a comparable peak EAdi (EAdipeak) as during PSP with a safety Paw upper limit of 30 cmH2O</description>
    <arm_group_label>NAVA ventilation</arm_group_label>
    <arm_group_label>PSN ventilation</arm_group_label>
    <arm_group_label>PSP ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PSN</intervention_name>
    <description>PSN, setting the NAVA level at its maximum (i.e; 15 cmH2O/mcV), and an upper Paw limit such to obtain the same overall Paw applied during PSP</description>
    <arm_group_label>NAVA ventilation</arm_group_label>
    <arm_group_label>PSN ventilation</arm_group_label>
    <arm_group_label>PSP ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The investigators considered eligible:&#xD;
&#xD;
          -  any patient ≥18 years admitted in ICU undergoing invasive mechanical ventilation for&#xD;
             at least 48 hours with a Glasgow Coma Scale (GCS) of 11 (i.e.; spontaneous eyes&#xD;
             opening, obeys to command, no verbal response because of the endotracheal tube in&#xD;
             place),&#xD;
&#xD;
          -  no infusion of midazolam and propofol in the previous 24 and 4 hours, respectively&#xD;
&#xD;
          -  ready for extubation with indication, prior to extubation, to receive prophylactic NIV&#xD;
             to prevent post-extubation respiratory failure.&#xD;
&#xD;
        Patients were excluded in case of&#xD;
&#xD;
          -  need for analgesic or sedative drugs,&#xD;
&#xD;
          -  recent cervical spine injury,&#xD;
&#xD;
          -  obstructive sleep apnoea syndrome,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  contraindications to placement of a nasal-gastric feeding tube,&#xD;
&#xD;
          -  inclusion in other research protocol&#xD;
&#xD;
          -  lack of consent.&#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>Pan Chun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Critical Care Medicine, Zhongda Hospital, Southeast University, School of Medicine, 87 Dingjiaqiao Street, Nanjing 210009, China</affiliation>
  </overall_official>
  <results_reference>
    <citation>Cammarota G, Longhini F, Perucca R, Ronco C, Colombo D, Messina A, Vaschetto R, Navalesi P. New Setting of Neurally Adjusted Ventilatory Assist during Noninvasive Ventilation through a Helmet. Anesthesiology. 2016 Dec;125(6):1181-1189. doi: 10.1097/ALN.0000000000001354.</citation>
    <PMID>27649505</PMID>
  </results_reference>
  <results_reference>
    <citation>Navalesi P, Longhini F. Neurally adjusted ventilatory assist. Curr Opin Crit Care. 2015 Feb;21(1):58-64. doi: 10.1097/MCC.0000000000000167.</citation>
    <PMID>25486574</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>Schmidt M, Dres M, Raux M, Deslandes-Boutmy E, Kindler F, Mayaux J, Similowski T, Demoule A. Neurally adjusted ventilatory assist improves patient-ventilator interaction during postextubation prophylactic noninvasive ventilation. Crit Care Med. 2012 Jun;40(6):1738-44. doi: 10.1097/CCM.0b013e3182451f77.</citation>
    <PMID>22610179</PMID>
  </results_reference>
  <results_reference>
    <citation>Bertrand PM, Futier E, Coisel Y, Matecki S, Jaber S, Constantin JM. Neurally adjusted ventilatory assist vs pressure support ventilation for noninvasive ventilation during acute respiratory failure: a crossover physiologic study. Chest. 2013 Jan;143(1):30-36. doi: 10.1378/chest.12-0424.</citation>
    <PMID>22661448</PMID>
  </results_reference>
  <results_reference>
    <citation>Piquilloud L, Tassaux D, Bialais E, Lambermont B, Sottiaux T, Roeseler J, Laterre PF, Jolliet P, Revelly JP. Neurally adjusted ventilatory assist (NAVA) improves patient-ventilator interaction during non-invasive ventilation delivered by face mask. Intensive Care Med. 2012 Oct;38(10):1624-31. doi: 10.1007/s00134-012-2626-9. Epub 2012 Aug 3.</citation>
    <PMID>22885649</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Chun Pan</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>non-invasive ventilation</keyword>
  <keyword>Pressure Support Ventilation</keyword>
  <keyword>Neurally Adjusted Ventilatory Assist</keyword>
  <keyword>patient-ventilator interaction</keyword>
  <keyword>ventilator performance</keyword>
  <keyword>asynchrony</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/NCT03041402
org study id: Neural PSV during mask NIV
nct id: NCT03041402
lead sponsor: 
has dmc: No
Non invasive ventilation (NIV) is generally delivered by pneumatically triggered and
      cycled-off Pressure Support (PSP) through a facial mask. Compared to PSP, Neurally Adjusted
      Ventilatory Assist (NAVA), which is the only ventilatory mode using a non-pneumatic signal,
      i.e., diaphragm electrical activity (EAdi), to trigger and drive ventilator assistance,
      improves patient-ventilator interaction. A specific setting to generate neurally controlled
      Pressure Support (PSN) was recently proposed for delivering NIV by helmet. The investigators
      here compare PSN with PSP and NAVA during NIV by facial mask, with respect to arterial blood
      gases (ABGs), patient comfort, and patient-ventilator interaction and synchrony.

      Three 30-minute trials of NIV were randomly delivered to 14 patients immediately after
      extubation to prevent post-extubation respiratory failure: 1) PSP, with an inspiratory
      support ≥8 cmH2O; 2) NAVA, adjusting the NAVA level to achieve a comparable peak EAdi
      (EAdipeak) as during PSP; 3) PSN, setting the NAVA level at 15 cmH2O/mcV with an upper airway
      pressure (Paw) limit such to obtain the same overall Paw applied during PSP. We assessed
      EAdipeak, ABGs, peak inspiratory flow (PIF), time to reach PIF (PIFtime), pressure-time
      product of the first 300 (PTP300-index) and 500 (PTP500-index) milliseconds after initiation
      of patient effort, patient comfort, inspiratory trigger delay (DelayTR-insp), and the rate of
      asynchrony, as assessed by the Asynchrony Index (AI%).
Non Invasive Ventilation (NIV) is increasingly used for treatment of Acute Respiratory
      Failure (ARF) and is commonly applied through an oral-nasal mask by means of pneumatically
      triggered and cycled-off Pressure Support (PSP). Although better tolerated than invasive
      mechanical ventilation, NIV is characterized by drawbacks such as poor patient-ventilator
      interaction and discomfort, which are major determinants of NIV failure.

      In particular, the pneumatic signals, i.e., flow, volume and airway pressure (Paw), are leak
      sensitive and frequently cause patient-ventilator asynchrony. The only mode that does not use
      pneumatic signals to trigger and drive the ventilator is Neurally Adjusted Ventilator Assist
      (NAVA). In fact, with NAVA the ventilator assistance is under control of diaphragm electrical
      activity (EAdi), as assessed through an esophageal catheter. As opposed to PSP, NAVA has been
      repeatedly shown to improve patient-ventilator interaction and reduce asynchronies, both
      during invasive ventilation and NIV. However, NAVA is characterized by a lower rate of
      pressurization than PSP.

      Very recently, a specific NIV setting to generate a neurally, i.e., EAdi, controlled Pressure
      Support (PSN) has been proposed and applied during both invasive ventilation and NIV
      delivered via helmet. PSN consists in increasing the user-controlled gain factor (NAVA level)
      at maximum, while restraining inspiratory Paw by adjusting on the ventilator the upper
      pressure limit.

      During NIV delivered through helmets, PSN has been shown, compared to both PSP and NAVA, to
      result in better pressurization and triggering performance, which improve patient's comfort
      while reducing EAdi, without affecting respiratory rate and arterial blood gases (ABGs). Due
      to the different characteristics of helmets and masks, it is unclear whether these advantages
      could be extended to NIV delivered by mask. The investigators therefore designed this
      physiological study aimed at comparing PSN with PSP and NAVA, with respect to breathing
      pattern, respiratory drive, ABGs, pressurization and triggering performance, patient's
      comfort and patient-ventilator synchrony.

      After patient enrollment, a nasal-gastric feeding tube able to detect EAdi (EAdi catheter,
      Maquet Critical Care, Solna, Sweden) was placed and the correct positioning ascertained. The
      study was performed using a Servo-I ventilator (Maquet Critical Care, Solna, Sweden) equipped
      with a NIV software for air-leaks. The oral-nasal mask was individually selected for each
      patients based on the anthropometric characteristics and in order to minimize air leaks and
      optimize patient tolerance, among three different models, FreeMotion RT041 Non Vented Full
      Face Mask (Fisher and Paykel, Auckland, New Zealand), Ultra Mirage FFM-NV (ResMed, San Diego,
      CA, USA) and PerforMax Face Mask (Philips Respironics, Murrysville, PA, USA).

      All patients underwent three 30-minute trials in random order: 1) PSP, setting the
      inspiratory pressure support ≥8 cmH2O to obtain a tidal volume of 6-8 mL•kg-1 of body weight,
      the fastest rate of pressurization (0.0 sec) and I/E cycling at 35% of peak inspiratory flow
      (PIF); 2) NAVA, adjusting the NAVA level in order to achieve a comparable peak EAdi
      (EAdipeak) as during PSP with a safety Paw upper limit of 30 cmH2O; 3) PSN, setting the NAVA
      level at its maximum (i.e; 15 cmH2O/mcV), and an upper Paw limit such to obtain the same
      overall Paw applied during PSP. During both NAVA and PSN the trigger sensitivity was set at
      0.5 mcV while, the default cycling-off is 70% EAdipeak, as fixed by the manufacturer. PEEP
      was set by the attending physicians in a range between 5 and 10 cmH2O, and left unmodified
      throughout the whole study period. The inspiratory oxygen fraction (FiO2) was regulated to
      obtain peripheral oxygen saturation (SpO2) between 94% and 96%, before starting the protocol,
      and kept unmodified throughout the study period.

      The three modes of ventilation were applied according to a computer-generated random sequence
      using sealed, opaque numbered envelops. The envelopes were kept in the head of nurses' office
      in both institutions. The envelope was opened by the nurse in charge of the patient, and the
      sequence of modes to be applied communicated to the investigators.

      Predefined criteria for protocol interruption were: 1) need for emergency re-intubation; 2)
      SpO2 <90%, 3) acute respiratory acidosis, as defined by PaCO2 >50 mmHg and pH <7.30; 3)
      inability to expectorate secretions; 4) hemodynamic instability (i.e.; need for continuous
      infusion of dopamine or dobutamine >5 µg∙kg-1∙min-1, norepinephrine >0.1 µg∙kg-1∙min-1 or
      epinephrine or vasopressin at any dosage to maintain mean arterial blood pressure >60 mmHg);
      5) life-threatening arrhythmias or electrocardiographic signs of ischemia; or 6) loss of 2 or
      more points of GCS.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Rate of ventilator cycling (RRmec)
time frame: 30 minutes within the trial
measure: respiratory drive (Peak of Electrical Activity of the Diaphragm)
time frame: 30 minutes within the trial
measure: arterial blood gases
time frame: 30 minutes within the trial
measure: Pressure-time product (PTP) of the first 200 ms from the onset of the ventilator pressurization (PTP200)
time frame: 30 minutes within the trial
measure: patient's comfort through an 11-point Numeric Rating Scale (NRS)
time frame: 30 minutes within the trial
measure: inspiratory trigger delay (DelayTR-insp), as the time lag between the onset of neural inspiration and ventilator support
time frame: 30 minutes within the trial
arm group label: PSP ventilation
arm group type: Active Comparator
description: PSP, setting the inspiratory pressure support ≥8 cmH2O to obtain a tidal volume of 6-8 mL•kg-1 of body weight, the fastest rate of pressurization (0.0 sec) and I/E cycling at 35% of peak inspiratory flow
arm group label: NAVA ventilation
arm group type: Active Comparator
description: NAVA, adjusting the NAVA level in order to achieve a comparable peak EAdi (EAdipeak) as during PSP with a safety Paw upper limit of 30 cmH2O
arm group label: PSN ventilation
arm group type: Experimental
description: PSN, setting the NAVA level at its maximum (i.e; 15 cmH2O/mcV), and an upper Paw limit such to obtain the same overall Paw applied during PSP
intervention type: Other
intervention name: PSP
description: PSP, setting the inspiratory pressure support ≥8 cmH2O to obtain a tidal volume of 6-8 mL•kg-1 of body weight, the fastest rate of pressurization (0.0 sec) and I/E cycling at 35% of peak inspiratory flow
arm group label: NAVA ventilation
arm group label: PSN ventilation
arm group label: PSP ventilation
intervention type: Other
intervention name: NAVA
description: NAVA, adjusting the NAVA level in order to achieve a comparable peak EAdi (EAdipeak) as during PSP with a safety Paw upper limit of 30 cmH2O
arm group label: NAVA ventilation
arm group label: PSN ventilation
arm group label: PSP ventilation
intervention type: Other
intervention name: PSN
description: PSN, setting the NAVA level at its maximum (i.e; 15 cmH2O/mcV), and an upper Paw limit such to obtain the same overall Paw applied during PSP
arm group label: NAVA ventilation
arm group label: PSN ventilation
arm group label: PSP ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pan Chun, MD
role: Principal Investigator
affiliation: Department of Critical Care Medicine, Zhongda Hospital, Southeast University, School of Medicine, 87 Dingjiaqiao Street, Nanjing 210009, China
citation: Cammarota G, Longhini F, Perucca R, Ronco C, Colombo D, Messina A, Vaschetto R, Navalesi P. New Setting of Neurally Adjusted Ventilatory Assist during Noninvasive Ventilation through a Helmet. Anesthesiology. 2016 Dec;125(6):1181-1189. doi: 10.1097/ALN.0000000000001354.
PMID: 27649505
citation: Navalesi P, Longhini F. Neurally adjusted ventilatory assist. Curr Opin Crit Care. 2015 Feb;21(1):58-64. doi: 10.1097/MCC.0000000000000167.
PMID: 25486574
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: Schmidt M, Dres M, Raux M, Deslandes-Boutmy E, Kindler F, Mayaux J, Similowski T, Demoule A. Neurally adjusted ventilatory assist improves patient-ventilator interaction during postextubation prophylactic noninvasive ventilation. Crit Care Med. 2012 Jun;40(6):1738-44. doi: 10.1097/CCM.0b013e3182451f77.
PMID: 22610179
citation: Bertrand PM, Futier E, Coisel Y, Matecki S, Jaber S, Constantin JM. Neurally adjusted ventilatory assist vs pressure support ventilation for noninvasive ventilation during acute respiratory failure: a crossover physiologic study. Chest. 2013 Jan;143(1):30-36. doi: 10.1378/chest.12-0424.
PMID: 22661448
citation: Piquilloud L, Tassaux D, Bialais E, Lambermont B, Sottiaux T, Roeseler J, Laterre PF, Jolliet P, Revelly JP. Neurally adjusted ventilatory assist (NAVA) improves patient-ventilator interaction during non-invasive ventilation delivered by face mask. Intensive Care Med. 2012 Oct;38(10):1624-31. doi: 10.1007/s00134-012-2626-9. Epub 2012 Aug 3.
PMID: 22885649
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Chun Pan
investigator title: MD
mesh term: Respiratory Insufficiency
sharing ipd: No