<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/NCT03826797</url>
  </required_header>
  <id_info>
    <org_study_id>UModenaReggio 266/16</org_study_id>
    <secondary_id>266/16</secondary_id>
    <nct_id>NCT03826797</nct_id>
  </id_info>
  <brief_title>Correlation Between Trans Esophageal Pressure and Non-invasive Respiratory Support Failure in Patients With Acute Hypoxic Respiratory Failure</brief_title>
  <acronym>TEMPO</acronym>
  <official_title>Correlation Between Trans Esophageal Pressure and Non-invasive Respiratory Support Failure in Patients With Acute Hypoxic Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Modena and Reggio Emilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Modena and Reggio Emilia</source>
  <oversight_info>
    <has_dmc>No</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>
      This study aims at assessing the correlation between trans esophageal pressure and related&#xD;
      respiratory mechanics (including, among others, nasal pressure-Pnose) and non-invasive&#xD;
      respiratory support failure in patients with acute hypoxic respiratory failure of different&#xD;
      etiology (including COVID-19).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 16, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2024</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>Esophageal pressure impact on non invasive respiratory support (NRS) failure</measure>
    <time_frame>24 hours</time_frame>
    <description>Correlation between esophageal pressure values within 24 hours from NRS start and NRS failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transpulmonary pressure impact on NRS failure</measure>
    <time_frame>24 hours</time_frame>
    <description>Correlation between transpulmonary pressure values within 24 hours from NRS start and NRS failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic compliance impact on NRS failure</measure>
    <time_frame>24 hours</time_frame>
    <description>Correlation between dynamic compliance values within 24 hours from NRS start and NRS failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic mechanical power impact on NRS failure</measure>
    <time_frame>24 hours</time_frame>
    <description>Correlation between dynamic mechanical power within 24 hours from NRS start and NRS failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between nasal pressure (Pnose) and esophageal pressure</measure>
    <time_frame>24 hours</time_frame>
    <description>Correlation between nasal pressure (Pnose) and esophageal pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pnose impact on NRS failure</measure>
    <time_frame>24 hours</time_frame>
    <description>Correlation between Pnose within 24 hours from NRS start and NRS failure</description>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        See inclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Acute hypoxic respiratory failure (P/F &lt; 200)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute pulmonary edema&#xD;
&#xD;
          -  Chest wall deformities&#xD;
&#xD;
          -  Immediate need for Mechanical Ventilation&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Hypercapnic RF&#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_contact>
    <last_name>Alessandro Marchioni, MD, PhD</last_name>
    <phone>00390594225859</phone>
    <email>marchioni.alessandro@unimore.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital of Modena Policlinico</name>
      <address>
        <city>Modena</city>
        <zip>41125</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alessandro Marchioni, MD, PhD</last_name>
      <email>marchioni.alessandro@unimore.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Modena and Reggio Emilia</investigator_affiliation>
    <investigator_full_name>Alessandro Marchioni</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Non invasive ventilation</keyword>
  <keyword>Esophageal pressure</keyword>
  <keyword>Transpulmonary pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03826797
org study id: UModenaReggio 266/16
secondary id: 266/16
nct id: NCT03826797
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims at assessing the correlation between trans esophageal pressure and related
      respiratory mechanics (including, among others, nasal pressure-Pnose) and non-invasive
      respiratory support failure in patients with acute hypoxic respiratory failure of different
      etiology (including COVID-19).
observational model: Cohort
time perspective: Prospective
measure: Esophageal pressure impact on non invasive respiratory support (NRS) failure
time frame: 24 hours
description: Correlation between esophageal pressure values within 24 hours from NRS start and NRS failure
measure: Transpulmonary pressure impact on NRS failure
time frame: 24 hours
description: Correlation between transpulmonary pressure values within 24 hours from NRS start and NRS failure
measure: Dynamic compliance impact on NRS failure
time frame: 24 hours
description: Correlation between dynamic compliance values within 24 hours from NRS start and NRS failure
measure: Dynamic mechanical power impact on NRS failure
time frame: 24 hours
description: Correlation between dynamic mechanical power within 24 hours from NRS start and NRS failure
measure: Correlation between nasal pressure (Pnose) and esophageal pressure
time frame: 24 hours
description: Correlation between nasal pressure (Pnose) and esophageal pressure
measure: Pnose impact on NRS failure
time frame: 24 hours
description: Correlation between Pnose within 24 hours from NRS start and NRS failure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alessandro Marchioni, MD, PhD
phone: 00390594225859
email: marchioni.alessandro@unimore.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Modena and Reggio Emilia
investigator full name: Alessandro Marchioni
investigator title: Principal Investigator
mesh term: Respiratory Insufficiency
sharing ipd: Undecided