<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/NCT03751579</url>
  </required_header>
  <id_info>
    <org_study_id>PI2018_843_0046</org_study_id>
    <nct_id>NCT03751579</nct_id>
  </id_info>
  <brief_title>Indirect Measurement of Respiratory Quotient in Coelioscopic Surgery</brief_title>
  <official_title>Validation of the Respiratory Quotient Measurement Measured Indirectly in Coelioscopic Surgery</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 RQ from the inspired and exhaled breath analysis of the anesthetic respirator to&#xD;
      predict the onset of anaerobic metabolism and postoperative complications in the operating&#xD;
      room.&#xD;
&#xD;
      But, because of artificially increase of carbon dioxide due to insufflation, coelioscopic&#xD;
      surgery was an exclusion criteria of our pilot study.&#xD;
&#xD;
      However, no study has examined the impact of coelioscopy on the indirect measurement of RQ&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no participant enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">May 1, 2019</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 by measurement of VO2 and VCO2</measure>
    <time_frame>during coelioscopic surgery</time_frame>
    <description>The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>occurence 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 occurence of at least one complication with the use of indirect respiratory quotient</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Respiratory Quotient Measurement</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>coelioscopic surgery</intervention_name>
    <description>observational study based on the computation of respiratory quotient in patient cohort treated by routine coelioscopic 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 coelioscopic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac and thoracic surgery&#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 coelioscopic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac and thoracic surgery&#xD;
&#xD;
          -  Preoperative oxygen therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>May 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>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>coelioscopic</keyword>
  <keyword>surgery complications</keyword>
  <keyword>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/NCT03751579
org study id: PI2018_843_0046
nct id: NCT03751579
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 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.

      But, because of artificially increase of carbon dioxide due to insufflation, coelioscopic
      surgery was an exclusion criteria of our pilot study.

      However, no study has examined the impact of coelioscopy on the indirect measurement of RQ
observational model: Cohort
time perspective: Prospective
measure: Indirect respiratory quotient by measurement of VO2 and VCO2
time frame: during coelioscopic surgery
description: The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2)
measure: occurence of at least one post-operative complication
time frame: through study completion, an average of 6 months
description: the aim is to predict the occurence of at least one complication with the use of indirect respiratory quotient
intervention type: Procedure
intervention name: coelioscopic surgery
description: observational study based on the computation of respiratory quotient in patient cohort treated by routine coelioscopic surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Sponsor