<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/NCT04471090</url>
  </required_header>
  <id_info>
    <org_study_id>PT-IMV</org_study_id>
    <nct_id>NCT04471090</nct_id>
  </id_info>
  <brief_title>Effects of Positional Therapy on Pulmonary Physiology in Patients Undergoing Mechanical Ventilation.</brief_title>
  <official_title>Effects of Positional Therapy on Pulmonary Physiology in Patients Undergoing Mechanical Ventilation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this project is to evaluate the effects of positional changes in mechanically&#xD;
      ventilated patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In critically ill patients undergoing invasive mechanical ventilation (IMV), several negative&#xD;
      effects converge, promoting the development of collapse in the dorsal areas of the lung.&#xD;
      These among others include deep sedation, relaxation, prolonged immobility and the supine&#xD;
      position. This results of an added impairment in lung function both in the mechanical and gas&#xD;
      exchange. In addition lung collapse contributes to a significant increase in the&#xD;
      heterogeneity the distribution of alveolar ventilation and perfusion that may increase the&#xD;
      risk of ventilator-induced lung injury (VILI).&#xD;
&#xD;
      Postural therapy is widely recommended as prevention/treatment of pressure ulcers, whose&#xD;
      presence, according to the Spanish Society of Intensive Care Medicine (SEMICYUC), is a&#xD;
      quality criterion for intensive care units (ICUs), with a prevalence of 18% in these units&#xD;
      compared to 7.8% in adult hospitalization. However, how postural changes may affect lung&#xD;
      function is an aspect that has been scarcely studied. Given the strong influence of gravity&#xD;
      on lung function, positional changes can produce significant alterations in the distribution&#xD;
      of trans-pulmonary pressures (a decrease along the vertical gravitational axis of&#xD;
      approximately 0.25 cmH2O per cm). Depending on the severity, distribution and location of the&#xD;
      respiratory pathology, positional changes may have a significant effect either benefiting or&#xD;
      impairing the patient's condition.&#xD;
&#xD;
      The investigators will dynamically assess the effects of routine lateral positioning up to&#xD;
      30-40º by means of electrical impedance tomography (EIT), a non-invasive, radiation-free&#xD;
      functional bedside imaging technique that allows to monitor the regional distribution of&#xD;
      ventilation and perfusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Regional ventilation and perfusion distribution ratio</measure>
    <time_frame>60 minutes</time_frame>
    <description>Percentage of relative ventilation in each Region Of Interest (ROI) in each of the studied positions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global mechanical compliance and regional impedance compliance</measure>
    <time_frame>60 minutes</time_frame>
    <description>Global mechanical compliance and regional impedance compliance (CZ) for each ROI in each of the studied positions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of lung mechanics.</measure>
    <time_frame>60 minutes</time_frame>
    <description>Changes in the lung mechanics during postural changes in their usual positions: supine position (SD), right lateral position (RLP) at 30º and left lateral position (LLP) at 30º. Global compliance and regional compliance (impedance arbitrary units/cmH2O)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of ventilation/perfusion lung distribution.</measure>
    <time_frame>60 minutes</time_frame>
    <description>Changes in the regional distribution of lung ventilation and perfusion during postural changes in their usual positions: supine position (SD), right lateral position (RLP) at 30º and left lateral position (LLP) at 30º. Percentage of relative ventilation and perfusion distribution in each region of interest (ROI). Relative distribution (%) and derived indexes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assesment of changes in ventilation/perfusion in prone position.</measure>
    <time_frame>60 minutes</time_frame>
    <description>Changes in ventilation and perfusion in prone position if during the study this circumstance arises due to medical indication. Percentage of relative ventilation and perfusion distribution in each region of interest (ROI). Relative distribution (%) and derived indexes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the effects of postural therapy in cases of predominantly unilateral lung pathology</measure>
    <time_frame>60 minutes</time_frame>
    <description>Effects of postural therapy in cases of predominantly unilateral lung pathology. Percentage of relative ventilation and perfusion distribution in each region of interest (ROI). Relative distribution (%) and derived indexes.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Critical Illness</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients admitted in the ICU of La Princesa University Hospital, Madrid,&#xD;
        Spain.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing IMV under sedation, in a controlled ventilatory modality in&#xD;
             passive conditions (i.e. without any spontaneous inspiratory efforts by the patient).&#xD;
&#xD;
          -  Signature of the informed consent by family member or legal representative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any clinical contraindication for postural therapy, including patient&#xD;
             haemodynamic instability, traumatism, pathology or any other cause.&#xD;
&#xD;
          -  Contraindication for the placement of the EIT electrode belt due to unstable spinal&#xD;
             cord injury or other skin injuries or wounds in the thoracic region (surgical,&#xD;
             traumatic, etc.)&#xD;
&#xD;
          -  Assisted ventilatory modes in a non-passive breathing patient.&#xD;
&#xD;
          -  Hypernatremia&#xD;
&#xD;
          -  Patients with pacemakers or implantable automatic defibrillators (IAD).&#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>Fernando Suarez Sipmann, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fernando Suarez Sipmann, MD PhD</last_name>
    <phone>+34 665052460</phone>
    <email>fsuarezsipmann@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario de La princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fernando Suarez Sipmann, MD PhD</last_name>
      <phone>+34 665052460</phone>
      <email>fsuarezsipmann@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</investigator_affiliation>
    <investigator_full_name>Fernando Suarez Sipmann</investigator_full_name>
    <investigator_title>MD PhD Intesive Care Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_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/NCT04471090
org study id: PT-IMV
nct id: NCT04471090
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this project is to evaluate the effects of positional changes in mechanically
      ventilated patients.
In critically ill patients undergoing invasive mechanical ventilation (IMV), several negative
      effects converge, promoting the development of collapse in the dorsal areas of the lung.
      These among others include deep sedation, relaxation, prolonged immobility and the supine
      position. This results of an added impairment in lung function both in the mechanical and gas
      exchange. In addition lung collapse contributes to a significant increase in the
      heterogeneity the distribution of alveolar ventilation and perfusion that may increase the
      risk of ventilator-induced lung injury (VILI).

      Postural therapy is widely recommended as prevention/treatment of pressure ulcers, whose
      presence, according to the Spanish Society of Intensive Care Medicine (SEMICYUC), is a
      quality criterion for intensive care units (ICUs), with a prevalence of 18% in these units
      compared to 7.8% in adult hospitalization. However, how postural changes may affect lung
      function is an aspect that has been scarcely studied. Given the strong influence of gravity
      on lung function, positional changes can produce significant alterations in the distribution
      of trans-pulmonary pressures (a decrease along the vertical gravitational axis of
      approximately 0.25 cmH2O per cm). Depending on the severity, distribution and location of the
      respiratory pathology, positional changes may have a significant effect either benefiting or
      impairing the patient's condition.

      The investigators will dynamically assess the effects of routine lateral positioning up to
      30-40º by means of electrical impedance tomography (EIT), a non-invasive, radiation-free
      functional bedside imaging technique that allows to monitor the regional distribution of
      ventilation and perfusion.
observational model: Case-Only
time perspective: Prospective
measure: Regional ventilation and perfusion distribution ratio
time frame: 60 minutes
description: Percentage of relative ventilation in each Region Of Interest (ROI) in each of the studied positions
measure: Global mechanical compliance and regional impedance compliance
time frame: 60 minutes
description: Global mechanical compliance and regional impedance compliance (CZ) for each ROI in each of the studied positions.
measure: Assessment of lung mechanics.
time frame: 60 minutes
description: Changes in the lung mechanics during postural changes in their usual positions: supine position (SD), right lateral position (RLP) at 30º and left lateral position (LLP) at 30º. Global compliance and regional compliance (impedance arbitrary units/cmH2O)
measure: Assessment of ventilation/perfusion lung distribution.
time frame: 60 minutes
description: Changes in the regional distribution of lung ventilation and perfusion during postural changes in their usual positions: supine position (SD), right lateral position (RLP) at 30º and left lateral position (LLP) at 30º. Percentage of relative ventilation and perfusion distribution in each region of interest (ROI). Relative distribution (%) and derived indexes.
measure: Assesment of changes in ventilation/perfusion in prone position.
time frame: 60 minutes
description: Changes in ventilation and perfusion in prone position if during the study this circumstance arises due to medical indication. Percentage of relative ventilation and perfusion distribution in each region of interest (ROI). Relative distribution (%) and derived indexes.
measure: Assessment of the effects of postural therapy in cases of predominantly unilateral lung pathology
time frame: 60 minutes
description: Effects of postural therapy in cases of predominantly unilateral lung pathology. Percentage of relative ventilation and perfusion distribution in each region of interest (ROI). Relative distribution (%) and derived indexes.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fernando Suarez Sipmann, MD PhD
role: Principal Investigator
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
last name: Fernando Suarez Sipmann, MD PhD
phone: +34 665052460
email: fsuarezsipmann@gmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
investigator full name: Fernando Suarez Sipmann
investigator title: MD PhD Intesive Care Medicine
mesh term: Critical Illness