<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/NCT03294928</url>
  </required_header>
  <id_info>
    <org_study_id>UPisa - 2017</org_study_id>
    <nct_id>NCT03294928</nct_id>
  </id_info>
  <brief_title>Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers</brief_title>
  <official_title>Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pisa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pisa</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>
      Population in study will be selected from students and staff of the University of Pisa. Right&#xD;
      carotid artery contour wave analysis will be performed during the application of different&#xD;
      PEEP levels (from 0 cmH2O to 10 cmH2O) with applanation tonometry technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">October 15, 2017</completion_date>
  <primary_completion_date type="Actual">October 5, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hemodynamic variations in wave reflection induced by the application of increasing levels of PEEP in healthy subjects.</measure>
    <time_frame>at rest and after 5 minutes</time_frame>
    <description>Mean blood pressure</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Blood Pressure</condition>
  <arm_group>
    <arm_group_label>progressive increasing of PEEP level</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>progressive increasing of PEEP level.</intervention_name>
    <description>four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level First step (Baseline) Subjects spontaneously breathe in air at atmospheric pressure during applanation tonometry.&#xD;
Second step (PEEP=5 cm H2O) Applanation tonometry was performed during the application of PEEP = 5 cmH2O (Oxygen flow = 8lt.- Air flow = 10 lt.).&#xD;
Third step (PEEP= 10 cm H2O) Applanation tonometry was performed during the application of PEEP = 10 cmH2O (Oxygen flow = 15lt.- Air flow = 20 lt.).&#xD;
Fourth step (Recovery) Subjects spontaneously rebreathe air at atmospheric pressure during applanation tonometry.</description>
    <arm_group_label>progressive increasing of PEEP level</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 40, absence of any chronic diseases, no smoke, no drugs&#xD;
             assumptions, no use of caffeine the day of the exam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy, chronic diseases, smokers, and intake of caffeine the day of the exam.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pisa</name>
      <address>
        <city>Pisa</city>
        <zip>56100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>January 4, 2018</last_update_submitted>
  <last_update_submitted_qc>January 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pisa</investigator_affiliation>
    <investigator_full_name>Prof. Carlo Palombo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03294928
org study id: UPisa - 2017
nct id: NCT03294928
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Population in study will be selected from students and staff of the University of Pisa. Right
      carotid artery contour wave analysis will be performed during the application of different
      PEEP levels (from 0 cmH2O to 10 cmH2O) with applanation tonometry technique.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: hemodynamic variations in wave reflection induced by the application of increasing levels of PEEP in healthy subjects.
time frame: at rest and after 5 minutes
description: Mean blood pressure
arm group label: progressive increasing of PEEP level
arm group type: Experimental
description: four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level.
intervention type: Other
intervention name: progressive increasing of PEEP level.
description: four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level First step (Baseline) Subjects spontaneously breathe in air at atmospheric pressure during applanation tonometry.
Second step (PEEP=5 cm H2O) Applanation tonometry was performed during the application of PEEP = 5 cmH2O (Oxygen flow = 8lt.- Air flow = 10 lt.).
Third step (PEEP= 10 cm H2O) Applanation tonometry was performed during the application of PEEP = 10 cmH2O (Oxygen flow = 15lt.- Air flow = 20 lt.).
Fourth step (Recovery) Subjects spontaneously rebreathe air at atmospheric pressure during applanation tonometry.
arm group label: progressive increasing of PEEP level
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Pisa
investigator full name: Prof. Carlo Palombo
investigator title: Professor