<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/NCT03751605</url>
  </required_header>
  <id_info>
    <org_study_id>PI2018_843_0047</org_study_id>
    <nct_id>NCT03751605</nct_id>
  </id_info>
  <brief_title>Indirect Measurement of Respiratory Quotient in Unipulmonary Ventilation.</brief_title>
  <official_title>Validation of the Respiratory Quotient Measurement Measured Indirectly in Unipulmonary Ventilation (UNIQ Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</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 measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ)&#xD;
      (VCO2 / VO2) which is a reflection of human energy metabolism and therefore of anaerobiosis.&#xD;
      A study has been conducted in our department to demonstrate the ability of the indirectly&#xD;
      measured respiratory quotient (RQ) from the inspired and exhaled breath analysis of the&#xD;
      anesthetic respirator to predict the onset of anaerobic metabolism and postoperative&#xD;
      complications in the operating room.&#xD;
&#xD;
      Unipulmonary ventilation is the rule in thoracic surgery: it improves surgical exposure and&#xD;
      protects the operated lung.&#xD;
&#xD;
      However, no study has examined the impact of these mechanisms on the indirect measurement of&#xD;
      RQ in unipulmonary ventilation. The main objective of our work is to validate indirect RQ&#xD;
      measurement during unipulmonary ventilation. The secondary objective was to assess the&#xD;
      predictability of postoperative complications of indirect QR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">February 1, 2023</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</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>Indirect respiratory quotient</measure>
    <time_frame>during surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>occurrence of at least one post-operative complication</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>the aim is to predict the occurrence of at least one complication with the use of indirect respiratory quotient</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Respiratory Quotient Measurement</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>unipulmonary ventilation</intervention_name>
    <description>observational study based on the computation of respiratory quotient in patient cohort treated by unipulmonary ventilation in routine thoracic surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt;18 years old&#xD;
&#xD;
          -  Adults admitted to the operating room for thoracic surgery requiring unipulmonary&#xD;
             ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac surgery&#xD;
&#xD;
          -  Laparoscopy&#xD;
&#xD;
          -  Preoperative oxygen therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt;18 years old&#xD;
&#xD;
          -  Adults admitted to the operating room for thoracic surgery requiring unipulmonary&#xD;
             ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac surgery&#xD;
&#xD;
          -  Laparoscopy&#xD;
&#xD;
          -  Preoperative oxygen therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>unipulmonary ventilation, complications, respiratory quotient.</keyword>
  <!-- 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/NCT03751605
org study id: PI2018_843_0047
nct id: NCT03751605
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ)
      (VCO2 / VO2) which is a reflection of human energy metabolism and therefore of anaerobiosis.
      A study has been conducted in our department to demonstrate the ability of the indirectly
      measured respiratory quotient (RQ) from the inspired and exhaled breath analysis of the
      anesthetic respirator to predict the onset of anaerobic metabolism and postoperative
      complications in the operating room.

      Unipulmonary ventilation is the rule in thoracic surgery: it improves surgical exposure and
      protects the operated lung.

      However, no study has examined the impact of these mechanisms on the indirect measurement of
      RQ in unipulmonary ventilation. The main objective of our work is to validate indirect RQ
      measurement during unipulmonary ventilation. The secondary objective was to assess the
      predictability of postoperative complications of indirect QR.
observational model: Cohort
time perspective: Prospective
measure: Indirect respiratory quotient
time frame: during surgery
measure: occurrence of at least one post-operative complication
time frame: through study completion, an average of 6 months
description: the aim is to predict the occurrence of at least one complication with the use of indirect respiratory quotient
intervention type: Procedure
intervention name: unipulmonary ventilation
description: observational study based on the computation of respiratory quotient in patient cohort treated by unipulmonary ventilation in routine thoracic surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: France
responsible party type: Sponsor