<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/NCT03270826</url>
  </required_header>
  <id_info>
    <org_study_id>23031990</org_study_id>
    <nct_id>NCT03270826</nct_id>
  </id_info>
  <brief_title>Physiological Behavior of Respiratory Maneuvers</brief_title>
  <official_title>Physiological Behavior of Respiratory Maneuvers Through Electrical Impedance Tomography and Optoelectronic Plethymography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Pernambuco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Pernambuco</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>
      Introduction: new methods of evaluation of respiratory function, such as electrical impedance&#xD;
      tomography (EIT) and optoelectronic plethysmography (OEP), have been used to measure regional&#xD;
      pulmonary ventilation and the variation of tricompartmental volumes of the thoracic cavity,&#xD;
      respectively. Analysis of these instruments during maximal respiratory maneuvers with&#xD;
      monitoring of esophageal pressure may probably provide additional information on the&#xD;
      physiological behavior of the cardiorespiratory system during EIT and OEP maneuvers.&#xD;
      Objectives: To describe the physiological behavior of maximal respiratory maneuvers through&#xD;
      the electrical impedance tomography and optoelectronic plethysmography in healthy men.&#xD;
&#xD;
      METHODS: This is a cross-sectional study involving 10 healthy male volunteers. The&#xD;
      development of the method will take place in 3 stages. The first step corresponds to the&#xD;
      characterization of the inspiratory and expiratory curves in the respiratory cycle generated&#xD;
      by the impedance variation (ΔZ), the mobility of the chest wall and the pulmonary volume&#xD;
      curve during maximal respiratory maneuvers. 2nd stage: verification of the correlation&#xD;
      between the variables Step 3: Estimate the dislocated blood volume of the lung through&#xD;
      previous analyzes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The physiological repercussions resulting from the maximal respiratory maneuvers together&#xD;
      with the synchronized analysis of the chest cavity mobility, pulmonary volume , pulmonary&#xD;
      impedance and measurement of Oesophageal pressure is not known. Therefore, this study aims to&#xD;
      describe the physiological behavior of maximal respiratory maneuvers through the&#xD;
      synchronization between electrical impedance tomography and optoelectronic plethysmography in&#xD;
      healthy men.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 7, 2017</start_date>
  <completion_date type="Actual">March 23, 2018</completion_date>
  <primary_completion_date type="Actual">February 20, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Displacement of blood volume of the lung</measure>
    <time_frame>09/03/2018</time_frame>
    <description>Volume displacement per unit time measured by electrical impedance tomography through the impedance variation in Ohm (Ω).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variation of pulmonary electrical impedance</measure>
    <time_frame>09/03/2018</time_frame>
    <description>Variation between the final and initial impedance measured by electrical impedance tomography through the impedance variation in Ohm (Ω).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Lung volume</measure>
    <time_frame>09/03/2018</time_frame>
    <description>Measurement of the amount of air that the lungs may contain at various points in the respiratory cycle.</description>
  </other_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy Volunteers</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study sample will be composed of healthy male volunteers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Will be included in the study male volunteers,&#xD;
&#xD;
          -  BMI greater than or equal to 18.5 and less than 25 kg / m2, considered adequate or&#xD;
             eutrophic (MS, 2011)&#xD;
&#xD;
          -  Chest circumference between 44 and 55 cm if fitted to the electrical impedance&#xD;
             tomography (EIT) strap size P or M;&#xD;
&#xD;
          -  systolic blood pressure lower than 140 mmHg and greater than 100 mmHg&#xD;
&#xD;
          -  diastolic blood pressure greater than 60 mmHg and lower than 90 mmHg (VI Brazilian&#xD;
             Guidelines for Hypertension, 2010)&#xD;
&#xD;
          -  without reports of cardiovascular or pulmonary diseases and symptoms Last month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers who refuse to participate in the study will be excluded from the survey;&#xD;
&#xD;
          -  Presence of cardiac dysfunction assessed by echocardiography;&#xD;
&#xD;
          -  Altered pulmonary function by spirometry (PEREIRA et al, 2001) and manovacuometry&#xD;
             according to predicted values for healthy individuals (PESSOA et al, 2014).&#xD;
&#xD;
          -  Presence of tissue injury in the thorax;&#xD;
&#xD;
          -  Dysautonomia that may indicate dysfunction of the autonomic nervous system (ANS), with&#xD;
             following clinical manifestations: seizures; epilepsy; Anhydrosis and hyperhidrosis;&#xD;
             Neurogenic bladder (CASTRO et al, 1992); (Stewart et al., 2004 and 2005)&#xD;
&#xD;
          -  individuals who donated blood or had significant blood loss within 30 days prior to&#xD;
             the start of the study (Navarro et al, 1997).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cláudia Thais Pinto, Ms</last_name>
    <role>Principal Investigator</role>
    <affiliation>UFPE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Federal de Pernambuco</name>
      <address>
        <city>Recife</city>
        <state>PE - Pernambuco</state>
        <zip>50740300</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>June 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Pernambuco</investigator_affiliation>
    <investigator_full_name>Cláudia Thais Pereira Pinto</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT03270826
org study id: 23031990
nct id: NCT03270826
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction: new methods of evaluation of respiratory function, such as electrical impedance
      tomography (EIT) and optoelectronic plethysmography (OEP), have been used to measure regional
      pulmonary ventilation and the variation of tricompartmental volumes of the thoracic cavity,
      respectively. Analysis of these instruments during maximal respiratory maneuvers with
      monitoring of esophageal pressure may probably provide additional information on the
      physiological behavior of the cardiorespiratory system during EIT and OEP maneuvers.
      Objectives: To describe the physiological behavior of maximal respiratory maneuvers through
      the electrical impedance tomography and optoelectronic plethysmography in healthy men.

      METHODS: This is a cross-sectional study involving 10 healthy male volunteers. The
      development of the method will take place in 3 stages. The first step corresponds to the
      characterization of the inspiratory and expiratory curves in the respiratory cycle generated
      by the impedance variation (ΔZ), the mobility of the chest wall and the pulmonary volume
      curve during maximal respiratory maneuvers. 2nd stage: verification of the correlation
      between the variables Step 3: Estimate the dislocated blood volume of the lung through
      previous analyzes.
The physiological repercussions resulting from the maximal respiratory maneuvers together
      with the synchronized analysis of the chest cavity mobility, pulmonary volume , pulmonary
      impedance and measurement of Oesophageal pressure is not known. Therefore, this study aims to
      describe the physiological behavior of maximal respiratory maneuvers through the
      synchronization between electrical impedance tomography and optoelectronic plethysmography in
      healthy men.
observational model: Other
time perspective: Cross-Sectional
measure: Displacement of blood volume of the lung
time frame: 09/03/2018
description: Volume displacement per unit time measured by electrical impedance tomography through the impedance variation in Ohm (Ω).
measure: Variation of pulmonary electrical impedance
time frame: 09/03/2018
description: Variation between the final and initial impedance measured by electrical impedance tomography through the impedance variation in Ohm (Ω).
measure: Lung volume
time frame: 09/03/2018
description: Measurement of the amount of air that the lungs may contain at various points in the respiratory cycle.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cláudia Thais Pinto, Ms
role: Principal Investigator
affiliation: UFPE
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Pernambuco
investigator full name: Cláudia Thais Pereira Pinto
investigator title: Principal Investigator
sharing ipd: No