<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/NCT02997072</url>
  </required_header>
  <id_info>
    <org_study_id>SilesianMU-PVA1</org_study_id>
    <nct_id>NCT02997072</nct_id>
  </id_info>
  <brief_title>Lungs Aeration Changes Examined by Impedance Tomography During High Frequency Jet Ventilation.</brief_title>
  <acronym>DPEIT</acronym>
  <official_title>Assessment of Regional Lungs Aeration Changes Examined by Impedance Tomography, Depending on the Drive Pressure Applied During High Frequency Jet Ventilation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Silesian University of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Silesian University of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is attempt to establish optimum drive pressure of high frequency&#xD;
      jet ventilation during rigid bronchoscopy to ensure good aeration of the lungs examined by&#xD;
      electrical impedance tomography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was performed in the Department of Anaesthesiology and Intensive Therapy in Zabrze.&#xD;
&#xD;
      After application of eligibility criteria 30 patients were enrolled in a prospective,&#xD;
      observational study. Each patient received an information about the study and the consent&#xD;
      form to carry out the measurement procedures was obtained. The data about sex, age, weight,&#xD;
      height, comorbidities, BMI were collected.&#xD;
&#xD;
      Patients were given premedication, midazolam (Sopodorm, ICN Polfa Rzeszow, Poland; doses:&#xD;
      weight 80kg - 7.5 mg; weight 80-100kg - 15mg) on hour before projected surgery.&#xD;
&#xD;
      Upon arrival to the operating room patient's basic monitoring was provided: ECG (3 leads),&#xD;
      heart rate, noninvasive measurement of blood pressure (NIBP), and pulse oximetry. At the same&#xD;
      time, a belt with electrodes was put on a patient to monitor impedance tomography, then an&#xD;
      automatical record of the basic parameters of regional lung ventilation was turned on.&#xD;
&#xD;
      The medications used for induction of anesthesia: fentanyl (Fentanyl WZF, Polfa Warsaw,&#xD;
      Poland) at a dose of 2 g /kg bw i.v., propofol (Diprivan, AstraZeneca, PolskaPlofed Polpharma&#xD;
      Poland) at a dose of 2 mg / kg bw, i.v. and to carry out an intubation - cis-atracurium&#xD;
      (Nimbex, GlaxoSmithKine, UK) at dose of 0.15 mg /kg bw i.v. During rigid bronchoscopy&#xD;
      maintenance of general anesthesia was achieved through the supply of intravenous propofol at&#xD;
      a dose of 10 - 6 mg/kg bw/h.The high frequency jet ventilation (HFJV) was performed with&#xD;
      proper respirator (Universal Jet Ventilator Monsoon DeLuxe ACUTRONIC Switzerland), using&#xD;
      following ventilation parameters: f = 160-200 breaths / min, FiO2 (fraction of inspired&#xD;
      oxygen) = 1, the DP (drive pressure) = 1.5-2.5 Atm. Simultaneously, patients were monitored&#xD;
      using a PulmoVista 500 Dräger device and aeration of the lungs examined by electrical&#xD;
      impedance tomography were observed in a monitor.&#xD;
&#xD;
      During anesthesia, patients received hydration in the form of a 0.9% solution of Ringer's&#xD;
      lactate at 4 ml/kg bw/h. In the event of bradycardia atropine (Atropine sulfuricum, Polfa&#xD;
      Warsaw, Poland) at dose of 0.5 mg iv was given, in the event of a decrease in mean arterial&#xD;
      pressure below 70 mmHg or 25% compared to the output pressure, ephedrine (Ephedrinum&#xD;
      Hydrochloricum WZF, Polfa Warsaw, Poland) in fractionated doses of 5 mg iv (Max 25 mg) was&#xD;
      given and in the case of the ineffectiveness of the proceedings dopamine infusion (Dopaminum&#xD;
      Hydrochloricum WZF 4%, Polfa Warsaw, Poland) in the syringe pump titrated to maintain a mean&#xD;
      arterial pressure above 70 mmHg.&#xD;
&#xD;
      Recovery from anesthesia took place at the recovery room after the removal of the anesthetics&#xD;
      and muscle relaxants. If necessary, reverse the action of muscle relaxants was announced&#xD;
      neostigmine (Polstygminum, Teva Pharmaceuticals Poland, Poland) at a dose of 0.5 - 2.5 mg&#xD;
      i.v.&#xD;
&#xD;
      During anesthesia following parameters were monitored: ECG (3 leads), heart rate, noninvasive&#xD;
      blood pressure (NIBP) every 3 minutes and arterial oxygen saturation measured by pulse&#xD;
      oximetry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Lung aeration corresponding to each layer of the lungs.</measure>
    <time_frame>10 minutes</time_frame>
    <description>The numerical values indicating the percentage of total increased resistance corresponding to each layer of the lungs (ROI - region of interests) that were collected in 15-seconds intervals.</description>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Thoracic Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Group of 30 patients hospitalized in 1st Clinical Hospital in Zabrze that were qualified&#xD;
        for planned thoracotomy or videothoracoscopy with the preceding rigid bronchoscopy&#xD;
        procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18&#xD;
&#xD;
          -  Obtained written consent form to participate in research&#xD;
&#xD;
          -  Patients qualified for rigid bronchoscopy procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of the written consent to participate in research&#xD;
&#xD;
          -  Undergoing urgent treatment&#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>Hanna Misiołek, MD, PhD, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>School of Medicine with the Division of Dentistry in Zabrze. Medical University of Silesia. Department of Anaesthesiology and Critical Care.</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Silesian University of Medicine</investigator_affiliation>
    <investigator_full_name>Katarzyna Rybczyk</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>electrical impedance tomography</keyword>
  <keyword>high frequency jet ventilation</keyword>
  <keyword>drive pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thoracic Diseases</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/NCT02997072
org study id: SilesianMU-PVA1
nct id: NCT02997072
lead sponsor: 
has dmc: No
The purpose of this study is attempt to establish optimum drive pressure of high frequency
      jet ventilation during rigid bronchoscopy to ensure good aeration of the lungs examined by
      electrical impedance tomography.
The study was performed in the Department of Anaesthesiology and Intensive Therapy in Zabrze.

      After application of eligibility criteria 30 patients were enrolled in a prospective,
      observational study. Each patient received an information about the study and the consent
      form to carry out the measurement procedures was obtained. The data about sex, age, weight,
      height, comorbidities, BMI were collected.

      Patients were given premedication, midazolam (Sopodorm, ICN Polfa Rzeszow, Poland; doses:
      weight 80kg - 7.5 mg; weight 80-100kg - 15mg) on hour before projected surgery.

      Upon arrival to the operating room patient's basic monitoring was provided: ECG (3 leads),
      heart rate, noninvasive measurement of blood pressure (NIBP), and pulse oximetry. At the same
      time, a belt with electrodes was put on a patient to monitor impedance tomography, then an
      automatical record of the basic parameters of regional lung ventilation was turned on.

      The medications used for induction of anesthesia: fentanyl (Fentanyl WZF, Polfa Warsaw,
      Poland) at a dose of 2 g /kg bw i.v., propofol (Diprivan, AstraZeneca, PolskaPlofed Polpharma
      Poland) at a dose of 2 mg / kg bw, i.v. and to carry out an intubation - cis-atracurium
      (Nimbex, GlaxoSmithKine, UK) at dose of 0.15 mg /kg bw i.v. During rigid bronchoscopy
      maintenance of general anesthesia was achieved through the supply of intravenous propofol at
      a dose of 10 - 6 mg/kg bw/h.The high frequency jet ventilation (HFJV) was performed with
      proper respirator (Universal Jet Ventilator Monsoon DeLuxe ACUTRONIC Switzerland), using
      following ventilation parameters: f = 160-200 breaths / min, FiO2 (fraction of inspired
      oxygen) = 1, the DP (drive pressure) = 1.5-2.5 Atm. Simultaneously, patients were monitored
      using a PulmoVista 500 Dräger device and aeration of the lungs examined by electrical
      impedance tomography were observed in a monitor.

      During anesthesia, patients received hydration in the form of a 0.9% solution of Ringer's
      lactate at 4 ml/kg bw/h. In the event of bradycardia atropine (Atropine sulfuricum, Polfa
      Warsaw, Poland) at dose of 0.5 mg iv was given, in the event of a decrease in mean arterial
      pressure below 70 mmHg or 25% compared to the output pressure, ephedrine (Ephedrinum
      Hydrochloricum WZF, Polfa Warsaw, Poland) in fractionated doses of 5 mg iv (Max 25 mg) was
      given and in the case of the ineffectiveness of the proceedings dopamine infusion (Dopaminum
      Hydrochloricum WZF 4%, Polfa Warsaw, Poland) in the syringe pump titrated to maintain a mean
      arterial pressure above 70 mmHg.

      Recovery from anesthesia took place at the recovery room after the removal of the anesthetics
      and muscle relaxants. If necessary, reverse the action of muscle relaxants was announced
      neostigmine (Polstygminum, Teva Pharmaceuticals Poland, Poland) at a dose of 0.5 - 2.5 mg
      i.v.

      During anesthesia following parameters were monitored: ECG (3 leads), heart rate, noninvasive
      blood pressure (NIBP) every 3 minutes and arterial oxygen saturation measured by pulse
      oximetry.
observational model: Cohort
time perspective: Prospective
measure: Lung aeration corresponding to each layer of the lungs.
time frame: 10 minutes
description: The numerical values indicating the percentage of total increased resistance corresponding to each layer of the lungs (ROI - region of interests) that were collected in 15-seconds intervals.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hanna Misiołek, MD, PhD, Prof
role: Study Chair
affiliation: School of Medicine with the Division of Dentistry in Zabrze. Medical University of Silesia. Department of Anaesthesiology and Critical Care.
responsible party type: Principal Investigator
investigator affiliation: Silesian University of Medicine
investigator full name: Katarzyna Rybczyk
investigator title: Principal Investigator
mesh term: Thoracic Diseases
sharing ipd: No