<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/NCT03758547</url>
  </required_header>
  <id_info>
    <org_study_id>Stefano Nava</org_study_id>
    <nct_id>NCT03758547</nct_id>
  </id_info>
  <brief_title>Effects of Secretion Removal in Ventilated Patients</brief_title>
  <official_title>Physiological Effects of the Application of Secretion Removal Device in Invasively Ventilated Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondazione Salvatore Maugeri</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the investigators will assess the effects of secretion removal on &quot;noninvasive&quot;&#xD;
      respiratory mechanics, in deeply sedated mechanically ventilated patients All the&#xD;
      mechanically ventilated patients will be submitted to the recording of compliance and&#xD;
      resistance at baseline (time0), immediately after the application of 10 cycles alternating 30&#xD;
      cmH20 during expiration and -30 cmH20 during exhalation (time1). Afterward the patients will&#xD;
      undergo an additional trail using the so called &quot;percussion&quot; technique, to assess any&#xD;
      synergic effect of this procedure (time2)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this observational study, the investigators will assess the effects of two secretion&#xD;
      removal techniques on passive respiratory mechanics, in patients undergoing invasive&#xD;
      mechanical ventilation.&#xD;
&#xD;
      Consecutive patients will undergo 3 sequential assessments at time0 (baseline), at time1&#xD;
      after the application of of 10 cycles alternating 30 cmH20 during expiration and -30 cmH20&#xD;
      during exhalation and finally after a 20 sec application of a &quot;percussion technique&quot;.&#xD;
&#xD;
      Protocol:&#xD;
&#xD;
      The patients will be ventilated without PEEP and sedated with a benzodiazepine infusion to&#xD;
      produce complete relaxation and adaptation to the ventilator, as assessed by the complete&#xD;
      absence of spontaneous efforts, so that there was no change in inspiratory flow rate, tidal&#xD;
      volume, or respiratory rate during the three measurement periods.&#xD;
&#xD;
      Airway pressure (Paw) and flow (V) will be measured continuously throughout the respiratory&#xD;
      cycle with the transducer and expiratory tidal volume will obtained by electrical integration&#xD;
      of the flow signal.&#xD;
&#xD;
      Arterial blood gas specimens will be withdrawn from the radial artery and analyzed with a&#xD;
      blood gas analyzer The patients will be studied in the semi recumbent position. After&#xD;
      baseline measurements of respiratory mechanics will recorded under control conditions.&#xD;
&#xD;
      Direct measurement of PEEPi will be obtained using the following method:&#xD;
&#xD;
      After several breaths under controlled mechanical ventilation, and with the patient relaxed,&#xD;
      the airway opening is occluded at the end of a tidal expiration, using the end-expiratory&#xD;
      hold button incorporated in the ventilator.&#xD;
&#xD;
      The occlusion will be then released for the mechanical lung inflation, and after a few&#xD;
      breaths the airway opening will be again occluded at the end of the inflation, using the&#xD;
      end-inspiratory hold button of the ventilator.&#xD;
&#xD;
      The static compliance of the total respiratory system (Cst rs) will be corrected for the&#xD;
      compliance of the ventilator tubing and the gas compression (0.8 ml/cm H20 2).&#xD;
&#xD;
      The end-inspiratory occlusion technique also allows determination of the inspiratory&#xD;
      resistive properties of the respiratory system, named R,rs min and R,rsmax, that means the&#xD;
      minimal respiratory resistances (those due mainly to the airways) and maximal respiratory&#xD;
      resistances (those mainly due to stress relaxation and Pendelluft)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>baseline (time0) application of 10 cycles of positive inspiratory and negative expiratory pressures (time1) application of percussion (time2)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>patients deeply sedated and therefore not conscious</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in passive respiratory mechanics</measure>
    <time_frame>immediate</time_frame>
    <description>RESPIRATORY MECHANICS is monitored using the end-expiratory and end inspiratory technique, obtained pressing the hold command on the ventilator</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in arterial blood gases</measure>
    <time_frame>immediate</time_frame>
    <description>changes in arterial partial oxygen tension and in arterial partial carbon dioxide tension obtained with a puncture of the radial artery</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>in-exufflator and percussion technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>assess the physiological effects, of a &quot;common&quot; daily practice of secretion removal in intubated patients, that are: in-exufflator technique and percussion technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>in-exufflator technique</intervention_name>
    <description>application through a device of 10 cycles using positive pressure (30 cmH20) during inspiration and negative pressure (-30 cmH20) during exhalation</description>
    <arm_group_label>in-exufflator and percussion technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>percussion technique</intervention_name>
    <description>sliding venturi system (phasitron), powered by compressed gas that can be changed from 0.8 up to 3.5 bar and that generates the oscillations in the range of 80-650 cycles/min</description>
    <arm_group_label>in-exufflator and percussion technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        consecutive ventilated and intubated patients&#xD;
&#xD;
          1. age&gt; 18 yrs&#xD;
&#xD;
          2. Sign inform consent&#xD;
&#xD;
          3. clinical indication for secretion removal from the endotracheal tube&#xD;
&#xD;
             -&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
               -  tracheotomy&#xD;
&#xD;
               -  bullous emphysema&#xD;
&#xD;
               -  pneumothorax&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</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>Chief of Respiratory and Critical Care unit</investigator_title>
  </responsible_party>
  <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>
    <ipd_description>not allow to release individual data of the patients</ipd_description>
  </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/NCT03758547
org study id: Stefano Nava
nct id: NCT03758547
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study the investigators will assess the effects of secretion removal on "noninvasive"
      respiratory mechanics, in deeply sedated mechanically ventilated patients All the
      mechanically ventilated patients will be submitted to the recording of compliance and
      resistance at baseline (time0), immediately after the application of 10 cycles alternating 30
      cmH20 during expiration and -30 cmH20 during exhalation (time1). Afterward the patients will
      undergo an additional trail using the so called "percussion" technique, to assess any
      synergic effect of this procedure (time2)
In this observational study, the investigators will assess the effects of two secretion
      removal techniques on passive respiratory mechanics, in patients undergoing invasive
      mechanical ventilation.

      Consecutive patients will undergo 3 sequential assessments at time0 (baseline), at time1
      after the application of of 10 cycles alternating 30 cmH20 during expiration and -30 cmH20
      during exhalation and finally after a 20 sec application of a "percussion technique".

      Protocol:

      The patients will be ventilated without PEEP and sedated with a benzodiazepine infusion to
      produce complete relaxation and adaptation to the ventilator, as assessed by the complete
      absence of spontaneous efforts, so that there was no change in inspiratory flow rate, tidal
      volume, or respiratory rate during the three measurement periods.

      Airway pressure (Paw) and flow (V) will be measured continuously throughout the respiratory
      cycle with the transducer and expiratory tidal volume will obtained by electrical integration
      of the flow signal.

      Arterial blood gas specimens will be withdrawn from the radial artery and analyzed with a
      blood gas analyzer The patients will be studied in the semi recumbent position. After
      baseline measurements of respiratory mechanics will recorded under control conditions.

      Direct measurement of PEEPi will be obtained using the following method:

      After several breaths under controlled mechanical ventilation, and with the patient relaxed,
      the airway opening is occluded at the end of a tidal expiration, using the end-expiratory
      hold button incorporated in the ventilator.

      The occlusion will be then released for the mechanical lung inflation, and after a few
      breaths the airway opening will be again occluded at the end of the inflation, using the
      end-inspiratory hold button of the ventilator.

      The static compliance of the total respiratory system (Cst rs) will be corrected for the
      compliance of the ventilator tubing and the gas compression (0.8 ml/cm H20 2).

      The end-inspiratory occlusion technique also allows determination of the inspiratory
      resistive properties of the respiratory system, named R,rs min and R,rsmax, that means the
      minimal respiratory resistances (those due mainly to the airways) and maximal respiratory
      resistances (those mainly due to stress relaxation and Pendelluft)
intervention model: Sequential Assignment
intervention model description: baseline (time0) application of 10 cycles of positive inspiratory and negative expiratory pressures (time1) application of percussion (time2)
primary purpose: Treatment
masking: None (Open Label)
masking description: patients deeply sedated and therefore not conscious
measure: Changes in passive respiratory mechanics
time frame: immediate
description: RESPIRATORY MECHANICS is monitored using the end-expiratory and end inspiratory technique, obtained pressing the hold command on the ventilator
measure: changes in arterial blood gases
time frame: immediate
description: changes in arterial partial oxygen tension and in arterial partial carbon dioxide tension obtained with a puncture of the radial artery
arm group label: in-exufflator and percussion technique
arm group type: Experimental
description: assess the physiological effects, of a "common" daily practice of secretion removal in intubated patients, that are: in-exufflator technique and percussion technique
intervention type: Device
intervention name: in-exufflator technique
description: application through a device of 10 cycles using positive pressure (30 cmH20) during inspiration and negative pressure (-30 cmH20) during exhalation
arm group label: in-exufflator and percussion technique
intervention type: Device
intervention name: percussion technique
description: sliding venturi system (phasitron), powered by compressed gas that can be changed from 0.8 up to 3.5 bar and that generates the oscillations in the range of 80-650 cycles/min
arm group label: in-exufflator and percussion technique
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: dr. Stefano Nava
investigator title: Chief of Respiratory and Critical Care unit
mesh term: Respiratory Insufficiency
sharing ipd: No
ipd description: not allow to release individual data of the patients