<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/NCT04442815</url>
  </required_header>
  <id_info>
    <org_study_id>EIT and ARF</org_study_id>
    <nct_id>NCT04442815</nct_id>
  </id_info>
  <brief_title>EIT in Patient Ventilator Asynchrony</brief_title>
  <official_title>Analysis of Patient Ventilator Asynchrony Using Electrical Impedance Tomography (EIT) in Patients With Acute Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patient-ventilator asynchrony is an important clinical issue in mechanically ventilated&#xD;
      patients. For patients with moderate to severe acute respiratory distress syndrome (ARDS),&#xD;
      various types of patient ventilator asynchrony may lead to injury of the lung. For example,&#xD;
      double cycling may lead to high tidal volume and pendelluft may result in transient&#xD;
      overstretch of dependent lung region. In this project, the investigators will record and&#xD;
      analyze various types of patient-ventilator asynchrony in ARDS patients and analyze the&#xD;
      regional distribution of lung gas and determined their harmful effect via concomitant&#xD;
      recording of EIT and transpulmonary pressure. The results may influence our ventilator&#xD;
      management of ARDS patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients and Methods:&#xD;
&#xD;
      Admitted ventilated patients who are greater than 18 years old and fulfilled the Berlin's&#xD;
      diagnostic criteria of moderate to severe ARDS will be selected to enter our study. The&#xD;
      exclusion criteria include (1) patients with metallic materials in the body (including wire,&#xD;
      pin or implanted electrical devices etc.); (2) patients with cutaneous diseases which&#xD;
      prohibited the application of electrode leads to attached the body; (3) severe chronic&#xD;
      obstructive pulmonary diseases; (4) hemodynamically unstable; (5) proved barotrauma&#xD;
      (including pneumothorax or pneumomediastinum etc.); (6) pregnancy; (7) diseases characterized&#xD;
      with increased intracranial pressure; (8) patients or family who refused the informed&#xD;
      consent. All patients who fulfilled the diagnosis of ARDS will receive standard care of low&#xD;
      tidal volume ventilator therapy. The tidal volume 6 ml/Kg will be used. The investigators&#xD;
      expect to enroll at least 20 analyzable cases. Sedation and paralysis are usually used in&#xD;
      moderate to severe ARDS patients and daily interruption of sedation and paralysis is a&#xD;
      standard practice. The investigators will perform recording during daily interruption of&#xD;
      sedation and paralysis, up to 60 minutes period will be recorded during the interruption&#xD;
      period. Recording will be done at least once for registered case and could be repeated in&#xD;
      case of unsatisfactory signals.&#xD;
&#xD;
      Instrumentation In all patients, air flow will be measured using a pneumotachograph (Hamilton&#xD;
      AG, or Hans Rudolf) connected to a differential pressure transducer (MP 45, Validyne Corp.,&#xD;
      Northridge, CA). The flow sensor will be placed between the endotracheal tube and the Y-piece&#xD;
      of the ventilator. Tidal volume will be obtained by integrating the flow signal. Airway&#xD;
      pressure and esophageal pressure will be measured using differential pressure transducers&#xD;
      (P300D, Validyne Corp., Northridge, CA.). An appropriate esophageal pressure signal will be&#xD;
      confirmed according to the standard guideline[27]. All signals are sampled and digitalized at&#xD;
      200 Hz and data are stored in a data acquisition system (MP150, Acqknowledgement, Biopac,&#xD;
      Goleta, CA).&#xD;
&#xD;
      Measurements:&#xD;
&#xD;
      Electrical impedance tomography:&#xD;
&#xD;
      The investigators use a commercial EIT monitor (PulmoVista 500, Drager Medical GmbH, Lubeck,&#xD;
      Germany). An electrode belt with 16 equally spaced electrodes will be placed around the&#xD;
      patient's thorax at the 4th to 5th intercostal space. Impedance data will be acquired by&#xD;
      applying adjacent alternate current injection (50 KHz) and measuring the voltage difference&#xD;
      between the adjacent leads and a finite element method-based, linearized Newton-Raphson&#xD;
      reconstruction algorithm is used to construct the impedance data. The PulmoVista 500 monitor&#xD;
      displays functional EIT images, i.e. relative impedance changes including tidal ventilation&#xD;
      and end-expiratory lung impedance (EELI) changes. During the study phases, EIT data will be&#xD;
      registered at 20-40 Hz and low-pass filtered (35 per minute) and stored for offline analysis.&#xD;
&#xD;
      The individual impedance recording (10 minutes per segment) will be linked into a single file&#xD;
      and impedance calculation will thus be done off-line. The investigators will subdivide the&#xD;
      impedance recordings into ventral to dorsal parts. The investigators define the presence of&#xD;
      pendelluft as the presence of opposite impedance change (△Z) between dependent and&#xD;
      independent zones during a breathing effort. The breath could occur in inspiration phase,&#xD;
      expiratory phase or in transition. Estimation of volume of pendelluft will be determined by&#xD;
      the integrated volume and corresponding impedance change.&#xD;
&#xD;
      Respiratory mechanics:&#xD;
&#xD;
      The investigators will record the peak and plateau airway pressure, total PEEP, flow and the&#xD;
      esophageal pressure. Transpulmonary pressure (PL) will be calculated as the difference&#xD;
      between Paw and Pes calculate the transpulmonary pressure.&#xD;
&#xD;
      Study protocol The investigators target at moderate to severe ARDS patients who are already&#xD;
      under deep sedation with neuromuscular blockade. As daily interruption of sedatives and&#xD;
      muscle relaxant are routinely performed in our ICU, we will record the respiratory mechanics&#xD;
      and EIT data for about one hour which should include both controlled and spontaneous&#xD;
      breathing period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2019</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Patient ventilator asynchrony</measure>
    <time_frame>up to 1 hour following interruption of muscle relaxant</time_frame>
    <description>Various types of patient ventilator asynchrony</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Regional ventilation distribution by EIT</measure>
    <time_frame>up to 1 hour following interruption of muscle relaxant</time_frame>
    <description>Regional ventilation distribution by EIT in various types of patient ventilator asynchrony</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospitalization day and final outcome</measure>
    <time_frame>up to 3 months</time_frame>
    <description>duration of hospitalization and hospital mortality</description>
  </secondary_outcome>
  <enrollment type="Actual">32</enrollment>
  <condition>ARDS, Human</condition>
  <eligibility>
    <study_pop>
      <textblock>
        moderate to severe ARDS patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of moderate to severe ARDS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe chronic obstructive pulmonary diseases&#xD;
&#xD;
          -  Proved barotrauma (including pneumothorax or pneumomediastinum etc.);&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Diseases characterized with increased intracranial pressure&#xD;
&#xD;
          -  Patients or family who refused the informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>all genders except pregnant woman</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chang-Wen Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cheng-Kung University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang-Wen Chen</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>December 23, 2022</last_update_submitted>
  <last_update_submitted_qc>December 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
    <investigator_full_name>Chang-Wen Chen</investigator_full_name>
    <investigator_title>Associate professor and attending physician</investigator_title>
  </responsible_party>
  <keyword>ARDS, patient-ventilator interaction, EIT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>IPD may be shared once the data is published</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/NCT04442815
org study id: EIT and ARF
nct id: NCT04442815
lead sponsor: 
has dmc: No
is fda regulated drug: No
Patient-ventilator asynchrony is an important clinical issue in mechanically ventilated
      patients. For patients with moderate to severe acute respiratory distress syndrome (ARDS),
      various types of patient ventilator asynchrony may lead to injury of the lung. For example,
      double cycling may lead to high tidal volume and pendelluft may result in transient
      overstretch of dependent lung region. In this project, the investigators will record and
      analyze various types of patient-ventilator asynchrony in ARDS patients and analyze the
      regional distribution of lung gas and determined their harmful effect via concomitant
      recording of EIT and transpulmonary pressure. The results may influence our ventilator
      management of ARDS patients.
Patients and Methods:

      Admitted ventilated patients who are greater than 18 years old and fulfilled the Berlin's
      diagnostic criteria of moderate to severe ARDS will be selected to enter our study. The
      exclusion criteria include (1) patients with metallic materials in the body (including wire,
      pin or implanted electrical devices etc.); (2) patients with cutaneous diseases which
      prohibited the application of electrode leads to attached the body; (3) severe chronic
      obstructive pulmonary diseases; (4) hemodynamically unstable; (5) proved barotrauma
      (including pneumothorax or pneumomediastinum etc.); (6) pregnancy; (7) diseases characterized
      with increased intracranial pressure; (8) patients or family who refused the informed
      consent. All patients who fulfilled the diagnosis of ARDS will receive standard care of low
      tidal volume ventilator therapy. The tidal volume 6 ml/Kg will be used. The investigators
      expect to enroll at least 20 analyzable cases. Sedation and paralysis are usually used in
      moderate to severe ARDS patients and daily interruption of sedation and paralysis is a
      standard practice. The investigators will perform recording during daily interruption of
      sedation and paralysis, up to 60 minutes period will be recorded during the interruption
      period. Recording will be done at least once for registered case and could be repeated in
      case of unsatisfactory signals.

      Instrumentation In all patients, air flow will be measured using a pneumotachograph (Hamilton
      AG, or Hans Rudolf) connected to a differential pressure transducer (MP 45, Validyne Corp.,
      Northridge, CA). The flow sensor will be placed between the endotracheal tube and the Y-piece
      of the ventilator. Tidal volume will be obtained by integrating the flow signal. Airway
      pressure and esophageal pressure will be measured using differential pressure transducers
      (P300D, Validyne Corp., Northridge, CA.). An appropriate esophageal pressure signal will be
      confirmed according to the standard guideline[27]. All signals are sampled and digitalized at
      200 Hz and data are stored in a data acquisition system (MP150, Acqknowledgement, Biopac,
      Goleta, CA).

      Measurements:

      Electrical impedance tomography:

      The investigators use a commercial EIT monitor (PulmoVista 500, Drager Medical GmbH, Lubeck,
      Germany). An electrode belt with 16 equally spaced electrodes will be placed around the
      patient's thorax at the 4th to 5th intercostal space. Impedance data will be acquired by
      applying adjacent alternate current injection (50 KHz) and measuring the voltage difference
      between the adjacent leads and a finite element method-based, linearized Newton-Raphson
      reconstruction algorithm is used to construct the impedance data. The PulmoVista 500 monitor
      displays functional EIT images, i.e. relative impedance changes including tidal ventilation
      and end-expiratory lung impedance (EELI) changes. During the study phases, EIT data will be
      registered at 20-40 Hz and low-pass filtered (35 per minute) and stored for offline analysis.

      The individual impedance recording (10 minutes per segment) will be linked into a single file
      and impedance calculation will thus be done off-line. The investigators will subdivide the
      impedance recordings into ventral to dorsal parts. The investigators define the presence of
      pendelluft as the presence of opposite impedance change (△Z) between dependent and
      independent zones during a breathing effort. The breath could occur in inspiration phase,
      expiratory phase or in transition. Estimation of volume of pendelluft will be determined by
      the integrated volume and corresponding impedance change.

      Respiratory mechanics:

      The investigators will record the peak and plateau airway pressure, total PEEP, flow and the
      esophageal pressure. Transpulmonary pressure (PL) will be calculated as the difference
      between Paw and Pes calculate the transpulmonary pressure.

      Study protocol The investigators target at moderate to severe ARDS patients who are already
      under deep sedation with neuromuscular blockade. As daily interruption of sedatives and
      muscle relaxant are routinely performed in our ICU, we will record the respiratory mechanics
      and EIT data for about one hour which should include both controlled and spontaneous
      breathing period.
observational model: Case-Only
time perspective: Prospective
measure: Patient ventilator asynchrony
time frame: up to 1 hour following interruption of muscle relaxant
description: Various types of patient ventilator asynchrony
measure: Regional ventilation distribution by EIT
time frame: up to 1 hour following interruption of muscle relaxant
description: Regional ventilation distribution by EIT in various types of patient ventilator asynchrony
measure: hospitalization day and final outcome
time frame: up to 3 months
description: duration of hospitalization and hospital mortality
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: all genders except pregnant woman
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chang-Wen Chen, MD
role: Principal Investigator
affiliation: National Cheng-Kung University Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng-Kung University Hospital
investigator full name: Chang-Wen Chen
investigator title: Associate professor and attending physician
mesh term: Respiratory Distress Syndrome
sharing ipd: Undecided
ipd description: IPD may be shared once the data is published