<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/NCT02264626</url>
  </required_header>
  <id_info>
    <org_study_id>116/2014O</org_study_id>
    <nct_id>NCT02264626</nct_id>
  </id_info>
  <brief_title>Sedation During Noninvasive Ventilation (NIV)</brief_title>
  <acronym>REMI</acronym>
  <official_title>Effects of Remifentanil Based Sedation on Patient-ventilator Interaction, in Patients Undergoing Noninvasive Ventilation (NIV)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason&#xD;
      of failure.&#xD;
&#xD;
      This may result in a poor synchrony between the patient and the machine, leading to gross&#xD;
      mismatching and potentially to an increased work of breathing.&#xD;
&#xD;
      The investigators aim to investigate whether in these patients poorly responding to NIV the&#xD;
      use of a sedation protocol using remifentanil will lead to an improve patient-ventilator&#xD;
      interaction and better compliance to NIV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason&#xD;
      of failure.&#xD;
&#xD;
      This may result in a poor synchrony between the patient and the machine, leading to gross&#xD;
      mismatching and potentially to an increased work of breathing.&#xD;
&#xD;
      The investigators aim to investigate whether in these patients poorly responding to NIV the&#xD;
      use of a sedation protocol using remifentanil will lead to an improve patient-ventilator&#xD;
      interaction and better compliance to NIV.&#xD;
&#xD;
      In this physiological study the investigators will study 15 patients at risk of failing NIV&#xD;
      because of scarce tolerance and showing clinical signs of poor interaction with the&#xD;
      ventilator.&#xD;
&#xD;
      Once the patient will be enrolled the investigators will record using the balloon-catheter&#xD;
      technique the online measurement of respiratory mechanics, to assess the inspiratory muscle&#xD;
      effort and the matching between the patient breathing pattern and that of the ventilator The&#xD;
      investigators will also record the clinical success of sedation (i.e. need or not for&#xD;
      endotracheal intubation)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>patient-ventilator interaction</measure>
    <time_frame>one hour</time_frame>
    <description>patient-ventilator interaction will be assessed using the recording of respiratory mechanics to identify</description>
  </primary_outcome>
  <primary_outcome>
    <measure>matching of inspiratory timing</measure>
    <time_frame>one hour</time_frame>
    <description>the patients inspiratory time vs ventilator inspiratory time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wasted efforts</measure>
    <time_frame>one hour</time_frame>
    <description>breaths unable to trigger the ventilator</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NIV failure</measure>
    <time_frame>one hour</time_frame>
    <description>failure will be defined as the need for intubation:&#xD;
gasping for air&#xD;
worsening of sensorium&#xD;
respiratory arrest&#xD;
retention of secretions and/ or death</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Acute Hypercapnic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>acutely ill patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administration of remifentanil at the infusion rate by 0.025 μg kg-1 min-1 to a maximum of 0.10 μg kg-1 min-1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>infusion at a rate by 0.025 μg kg-1 min-1 every minute to a maximum of 0.15 μg kg-1 min-1.</description>
    <arm_group_label>acutely ill patients</arm_group_label>
    <other_name>ultriva</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ph&lt;7,35 and PaCO2&gt;50 mmHg with acute respiratory failure&#xD;
&#xD;
          -  Signs of respiratory distress and poor synchrony with the ventilator as assessed on&#xD;
             the ventilator screen and by looking patient own rate and ventilator recorded rate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients responding well to NIV and not showing signs of poor synchrony&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>stefano nava, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>stefano nava, md</last_name>
    <phone>393333751828</phone>
  </overall_contact>
  <location>
    <facility>
      <name>San'Orsola Malpighi Hospital, Bologna ITALY</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefano Nava, MD</last_name>
      <phone>051 6364017</phone>
      <email>stefano.nava@aosp.bo.it</email>
    </contact>
    <investigator>
      <last_name>Stefano Nava, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 4, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 8, 2016</last_update_submitted>
  <last_update_submitted_qc>October 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>dr. Stefano Nava</investigator_full_name>
    <investigator_title>Professor of Respiratory Medicine</investigator_title>
  </responsible_party>
  <keyword>acute respiratory failure</keyword>
  <keyword>noninvasive ventilation</keyword>
  <keyword>sedation</keyword>
  <keyword>patient/ventilator interaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02264626
org study id: 116/2014O
nct id: NCT02264626
lead sponsor: 
has dmc: No
In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason
      of failure.

      This may result in a poor synchrony between the patient and the machine, leading to gross
      mismatching and potentially to an increased work of breathing.

      The investigators aim to investigate whether in these patients poorly responding to NIV the
      use of a sedation protocol using remifentanil will lead to an improve patient-ventilator
      interaction and better compliance to NIV.
In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason
      of failure.

      This may result in a poor synchrony between the patient and the machine, leading to gross
      mismatching and potentially to an increased work of breathing.

      The investigators aim to investigate whether in these patients poorly responding to NIV the
      use of a sedation protocol using remifentanil will lead to an improve patient-ventilator
      interaction and better compliance to NIV.

      In this physiological study the investigators will study 15 patients at risk of failing NIV
      because of scarce tolerance and showing clinical signs of poor interaction with the
      ventilator.

      Once the patient will be enrolled the investigators will record using the balloon-catheter
      technique the online measurement of respiratory mechanics, to assess the inspiratory muscle
      effort and the matching between the patient breathing pattern and that of the ventilator The
      investigators will also record the clinical success of sedation (i.e. need or not for
      endotracheal intubation)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: patient-ventilator interaction
time frame: one hour
description: patient-ventilator interaction will be assessed using the recording of respiratory mechanics to identify
measure: matching of inspiratory timing
time frame: one hour
description: the patients inspiratory time vs ventilator inspiratory time
measure: Wasted efforts
time frame: one hour
description: breaths unable to trigger the ventilator
measure: NIV failure
time frame: one hour
description: failure will be defined as the need for intubation:
gasping for air
worsening of sensorium
respiratory arrest
retention of secretions and/ or death
arm group label: acutely ill patients
arm group type: Experimental
description: administration of remifentanil at the infusion rate by 0.025 μg kg-1 min-1 to a maximum of 0.10 μg kg-1 min-1.
intervention type: Drug
intervention name: Remifentanil
description: infusion at a rate by 0.025 μg kg-1 min-1 every minute to a maximum of 0.15 μg kg-1 min-1.
arm group label: acutely ill patients
other name: ultriva
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: stefano nava, md
role: Principal Investigator
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
last name: stefano nava, md
phone: 393333751828
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: dr. Stefano Nava
investigator title: Professor of Respiratory Medicine
mesh term: Respiratory Insufficiency
mesh term: Remifentanil