<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/NCT02987309</url>
  </required_header>
  <id_info>
    <org_study_id>2016_InKal1</org_study_id>
    <nct_id>NCT02987309</nct_id>
  </id_info>
  <brief_title>Indirect Calorimetry: SensorMedics Vmax vs GE Carescape - a Method Comparison Study</brief_title>
  <official_title>Indirect Calorimetry: SensorMedics Vmax vs GE Carescape - a Method Comparison Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dosing of nutrition in PICUs is mainly based on patient weight and assumptions on clinical&#xD;
      status. There is however poor correlation between these calculations and actual energy&#xD;
      consumption measured with indirect calorimetry (IC). Available equipment for IC has however&#xD;
      been too cumbersome to use in daily clinical practice. Of relative new date is IC integrated&#xD;
      in modern ventilators. This functionality is easy to use, but we do not know if the results&#xD;
      are reliable for children. This study is a method comparison study comparing measurements&#xD;
      done with SensorMedics Vmax (&quot;gold standard&quot;) vs GE Carescape (modern ventilator with&#xD;
      Integrated IC) in children undergoing intensive care treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Equipment failure&#xD;
  </why_stopped>
  <start_date type="Actual">March 30, 2017</start_date>
  <completion_date type="Actual">February 24, 2020</completion_date>
  <primary_completion_date type="Actual">February 24, 2020</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>MEE (measured energy expenditure) kcal/kg/day, RQ (respiratory quotient)</measure>
    <time_frame>2 hours</time_frame>
    <description>Comparison of measurements made by two different instruments</description>
  </primary_outcome>
  <enrollment type="Actual">6</enrollment>
  <condition>Nutrition Assessment</condition>
  <condition>Critical Illness</condition>
  <condition>Children</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children undergoing intensive care treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age,&#xD;
&#xD;
          -  endotracheally intubated.&#xD;
&#xD;
          -  FiO2 &lt; 0,6, tube leak &lt; 10%, tidal volume &gt; 50 ml.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ventilatory and hemodynamically unstable during 2 hours prior to inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gunnar Bentsen, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital, Rikshospitalet</name>
      <address>
        <city>Oslo</city>
        <zip>0871</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Gunnar Bentsen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>indirect calorimetry</keyword>
  <keyword>method comparison</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <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/NCT02987309
org study id: 2016_InKal1
nct id: NCT02987309
lead sponsor: 
has dmc: No
Dosing of nutrition in PICUs is mainly based on patient weight and assumptions on clinical
      status. There is however poor correlation between these calculations and actual energy
      consumption measured with indirect calorimetry (IC). Available equipment for IC has however
      been too cumbersome to use in daily clinical practice. Of relative new date is IC integrated
      in modern ventilators. This functionality is easy to use, but we do not know if the results
      are reliable for children. This study is a method comparison study comparing measurements
      done with SensorMedics Vmax ("gold standard") vs GE Carescape (modern ventilator with
      Integrated IC) in children undergoing intensive care treatment.
observational model: Cohort
time perspective: Prospective
measure: MEE (measured energy expenditure) kcal/kg/day, RQ (respiratory quotient)
time frame: 2 hours
description: Comparison of measurements made by two different instruments
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Gunnar Bentsen, MD PhD
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Gunnar Bentsen
investigator title: Principal Investigator
mesh term: Critical Illness
sharing ipd: No