<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/NCT04482556</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00033440</org_study_id>
    <nct_id>NCT04482556</nct_id>
  </id_info>
  <brief_title>Comparison of the Q-NRG+ Indirect Calorimetry Device Versus the V(Max) Encore Device in Mechanically Ventilated Children</brief_title>
  <official_title>Comparison of the Q-NRG+ Indirect Calorimetry Device Versus the V(Max) Encore Device in Mechanically Ventilated Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overarching aim of this proposal is to examine the feasibility of the Q-NRG+ indirect&#xD;
      calorimetry device and its agreement with (Vmax) Encore indirect calorimetry device in&#xD;
      mechanically ventilated children. The overall hypothesis of this study is that the Q-NRG+&#xD;
      will provide minute-to-minute oxygen consumption (VO2) and carbon dioxide production (CO2)&#xD;
      measurements that are in agreement with those obtained by the standard indirect calorimetry&#xD;
      device currently used at our institution (Vmax Encore).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Indirect calorimetry allows accurate measurement of energy expenditure in this population but&#xD;
      current technology is cumbersome and time-consuming, and has many limitations that exclude a&#xD;
      majority of criticaly ill children. A new device was recently developed to address some of&#xD;
      the limitations of IC devices and is widely endorsed for IC measurements in critically ill&#xD;
      adults. The Q-NRG+ IC device incorporates an easier gas calibration technique to facilitate&#xD;
      faster start up, and a micro-mixing chamber (2ml) allows rapid achievement of steady state&#xD;
      gas exchange measurement. The device may address some of the current barriers for the use of&#xD;
      indirect calorimetry in critically ill children. A device with short calibration time and&#xD;
      reliable measurements could enhance the ability of clinicians to deliver individualized&#xD;
      energy prescriptions for patients.&#xD;
&#xD;
      Description of Study Treatments&#xD;
&#xD;
      Following informed consent, the following steps will be followed for the study procedure:&#xD;
&#xD;
        1. The two testing indirect calorimetry devices will be tested in an alternating fashion&#xD;
           for each enrolled patient, therefore it will be decided the V(max) will be tested first&#xD;
           in the first enrolled patient then the Q-NRG+ second. Each enrolled patient subsequently&#xD;
           will alternate in which device is tested first.&#xD;
&#xD;
        2. The first device will be connected to the patient, after calibration, and data&#xD;
           collection will begin for a maximum duration of 30 minutes.&#xD;
&#xD;
        3. At the end of the first testing period, the first device will be disconnected and the&#xD;
           second device will be connected to the study patient.&#xD;
&#xD;
        4. Data collection for the second device will then begin for a maximum duration of 30&#xD;
           minutes.&#xD;
&#xD;
        5. At the end of the testing period, the data collected for the V(max) device will be&#xD;
           discussed with the parents and the clinical team. Data collected from the Q-NRG+ will&#xD;
           not be shared with the clinical team or family as this device is still being&#xD;
           investigated in the pediatric population.&#xD;
&#xD;
        6. The study will then conclude.&#xD;
&#xD;
      Definitions of Outcomes/Endpoints The primary variables to be collected are steady state&#xD;
      measurements of VO2 and VCO2 from both indirect calorimetry devices. Steady state will be&#xD;
      defined as a period of greater than five minutes with coefficient of variation of the VO2 and&#xD;
      VCO2 measurements of less than 10%. If steady state is not achieved, energy calculations will&#xD;
      not be included in data analysis. Secondary variables to be collected include total time to&#xD;
      obtain indirect calorimetry measurement, from arrival at the bedside to completion of the&#xD;
      study. Steady state conditions will be defined using existing institutional practice.&#xD;
&#xD;
      Data Collection Methods and Assessments Descriptive characteristics will also be collected&#xD;
      for each patient including age, weight, height, diagnosis, severity of illness, length of ICU&#xD;
      stay, vital signs, and ventilator settings. We will also collect endotracheal tube size,&#xD;
      presence of cuff, leak percentage. We will also collect information about medications,&#xD;
      including inotropes and vasopressors, sedation medications (as well as SBS score) and&#xD;
      nutrition parameters. Markers of inflammation, WBC and CRP will be collected from the patient&#xD;
      chart.&#xD;
&#xD;
      Statistical Analysis Descriptive statistics will be computed for measured REE, VO2 and VCO2&#xD;
      and Bland-Altman analysis will be utilized to quantify the mean bias and limits of agreement&#xD;
      between devices. Acceptable limits of agreement between the devices will be +/- 20%. VO2, CO2&#xD;
      will be reported as means (SD). The time to steady state and total time of IC measurement&#xD;
      will be compared using a T-test (if normally distributed) or Mann-Whitney U-test (if not&#xD;
      normally distributed).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean bias and limits of agreement between measured oxygen consumption (VO2) and carbon dioxide elimination (VCO2) in mechanically ventilated children assessed using the Q-NRG+ indirect calorimetry device and the V(max) Encore indirect calorimetry device.</measure>
    <time_frame>1 hour/participant</time_frame>
    <description>In mechanically ventilated children, we will describe the mean bias and limits of agreement in measurements using both indirect calorimeters. Our hypothesis is that the measurement of oxygen consumption (VO2) and carbon dioxide production (VCO2) with the 2 devices will have a low mean bias and will be within clinically acceptable limits of agreement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Calculated total testing time, including calibration, required to complete a steady state indirect calorimetry measurement using the Q-NRG+ device and the V(max) Encore.</measure>
    <time_frame>1 hour/participant</time_frame>
    <description>Total time lapsed, including time for patient data input, warm-up, calibration, and gas exchange measurements in steady state will be recorded. Our hypothesis is that the time required to obtain energy expenditure with Q-NRG+ device will be significantly shorter as compared to the Vmax Encore device.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Calorimetry, Indirect</condition>
  <condition>Oxygen Consumption</condition>
  <condition>Metabolism</condition>
  <condition>Mechanical Ventilation</condition>
  <arm_group>
    <arm_group_label>Q-NRG+ Indirect Calorimetry Device</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Q-NRG+ device will be compared to current V(max) device in each enrolled patient in subsequent, alternating fashion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>V(max) Encore Indirect Calorimetry Device</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>V(max) Encore device, currently institution's standard device, will be compared to Q-NRG+ device in each enrolled patient in subsequent, alternating fashion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Q-NRG+ Indirect Calorimetry Device</intervention_name>
    <description>The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.</description>
    <arm_group_label>Q-NRG+ Indirect Calorimetry Device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>V(max) Encore Indirect Calorimetry Device</intervention_name>
    <description>The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.</description>
    <arm_group_label>V(max) Encore Indirect Calorimetry Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children mechanically ventilated with endotracheal tube of tracheostomy in standard&#xD;
             ventilatory modes such as SIMV-PC, SIMV-VC or PRVC&#xD;
&#xD;
          -  Age &gt; 10 years AND weight &gt; 10kg&#xD;
&#xD;
          -  FIO2 &lt; 60%&#xD;
&#xD;
          -  PEEP &lt; 8&#xD;
&#xD;
          -  ETT leak &lt; 10%&#xD;
&#xD;
          -  The attending physician of record plans to order indirect calorimetry and considers&#xD;
             research activity safe&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemodynamic instability (hypotension according to PALS/ACLS formula or requiring 2 or&#xD;
             greater vasoactive infusions)&#xD;
&#xD;
          -  Presence of chest tubes with ongoing air leak&#xD;
&#xD;
          -  Patients requiring ECMO support&#xD;
&#xD;
          -  Patients undergoing end-of-life care&#xD;
&#xD;
          -  Primary provider declines enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nilesh M Mehta, MD</last_name>
    <role>Study Director</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ben D Albert, MD</last_name>
    <phone>617-355-7327</phone>
    <email>ben.albert@childrens.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nilesh M Mehta, MD</last_name>
    <phone>617-355-7327</phone>
    <email>Nilesh.Mehta@childrens.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ben Albert, MD</last_name>
      <phone>617-355-7327</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Ben D. Albert, MD</investigator_full_name>
    <investigator_title>Director, Critical Care Medicine Fellowship Program</investigator_title>
  </responsible_party>
  <keyword>Pediatrics</keyword>
  <keyword>Indirect Calorimetry</keyword>
  <keyword>Enteral Nutrition</keyword>
  <keyword>Metabolism</keyword>
  <keyword>Critical Care</keyword>
  <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/NCT04482556
org study id: IRB-P00033440
nct id: NCT04482556
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The overarching aim of this proposal is to examine the feasibility of the Q-NRG+ indirect
      calorimetry device and its agreement with (Vmax) Encore indirect calorimetry device in
      mechanically ventilated children. The overall hypothesis of this study is that the Q-NRG+
      will provide minute-to-minute oxygen consumption (VO2) and carbon dioxide production (CO2)
      measurements that are in agreement with those obtained by the standard indirect calorimetry
      device currently used at our institution (Vmax Encore).
Indirect calorimetry allows accurate measurement of energy expenditure in this population but
      current technology is cumbersome and time-consuming, and has many limitations that exclude a
      majority of criticaly ill children. A new device was recently developed to address some of
      the limitations of IC devices and is widely endorsed for IC measurements in critically ill
      adults. The Q-NRG+ IC device incorporates an easier gas calibration technique to facilitate
      faster start up, and a micro-mixing chamber (2ml) allows rapid achievement of steady state
      gas exchange measurement. The device may address some of the current barriers for the use of
      indirect calorimetry in critically ill children. A device with short calibration time and
      reliable measurements could enhance the ability of clinicians to deliver individualized
      energy prescriptions for patients.

      Description of Study Treatments

      Following informed consent, the following steps will be followed for the study procedure:

        1. The two testing indirect calorimetry devices will be tested in an alternating fashion
           for each enrolled patient, therefore it will be decided the V(max) will be tested first
           in the first enrolled patient then the Q-NRG+ second. Each enrolled patient subsequently
           will alternate in which device is tested first.

        2. The first device will be connected to the patient, after calibration, and data
           collection will begin for a maximum duration of 30 minutes.

        3. At the end of the first testing period, the first device will be disconnected and the
           second device will be connected to the study patient.

        4. Data collection for the second device will then begin for a maximum duration of 30
           minutes.

        5. At the end of the testing period, the data collected for the V(max) device will be
           discussed with the parents and the clinical team. Data collected from the Q-NRG+ will
           not be shared with the clinical team or family as this device is still being
           investigated in the pediatric population.

        6. The study will then conclude.

      Definitions of Outcomes/Endpoints The primary variables to be collected are steady state
      measurements of VO2 and VCO2 from both indirect calorimetry devices. Steady state will be
      defined as a period of greater than five minutes with coefficient of variation of the VO2 and
      VCO2 measurements of less than 10%. If steady state is not achieved, energy calculations will
      not be included in data analysis. Secondary variables to be collected include total time to
      obtain indirect calorimetry measurement, from arrival at the bedside to completion of the
      study. Steady state conditions will be defined using existing institutional practice.

      Data Collection Methods and Assessments Descriptive characteristics will also be collected
      for each patient including age, weight, height, diagnosis, severity of illness, length of ICU
      stay, vital signs, and ventilator settings. We will also collect endotracheal tube size,
      presence of cuff, leak percentage. We will also collect information about medications,
      including inotropes and vasopressors, sedation medications (as well as SBS score) and
      nutrition parameters. Markers of inflammation, WBC and CRP will be collected from the patient
      chart.

      Statistical Analysis Descriptive statistics will be computed for measured REE, VO2 and VCO2
      and Bland-Altman analysis will be utilized to quantify the mean bias and limits of agreement
      between devices. Acceptable limits of agreement between the devices will be +/- 20%. VO2, CO2
      will be reported as means (SD). The time to steady state and total time of IC measurement
      will be compared using a T-test (if normally distributed) or Mann-Whitney U-test (if not
      normally distributed).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Mean bias and limits of agreement between measured oxygen consumption (VO2) and carbon dioxide elimination (VCO2) in mechanically ventilated children assessed using the Q-NRG+ indirect calorimetry device and the V(max) Encore indirect calorimetry device.
time frame: 1 hour/participant
description: In mechanically ventilated children, we will describe the mean bias and limits of agreement in measurements using both indirect calorimeters. Our hypothesis is that the measurement of oxygen consumption (VO2) and carbon dioxide production (VCO2) with the 2 devices will have a low mean bias and will be within clinically acceptable limits of agreement.
measure: Calculated total testing time, including calibration, required to complete a steady state indirect calorimetry measurement using the Q-NRG+ device and the V(max) Encore.
time frame: 1 hour/participant
description: Total time lapsed, including time for patient data input, warm-up, calibration, and gas exchange measurements in steady state will be recorded. Our hypothesis is that the time required to obtain energy expenditure with Q-NRG+ device will be significantly shorter as compared to the Vmax Encore device.
arm group label: Q-NRG+ Indirect Calorimetry Device
arm group type: Other
description: Q-NRG+ device will be compared to current V(max) device in each enrolled patient in subsequent, alternating fashion.
arm group label: V(max) Encore Indirect Calorimetry Device
arm group type: Other
description: V(max) Encore device, currently institution's standard device, will be compared to Q-NRG+ device in each enrolled patient in subsequent, alternating fashion.
intervention type: Device
intervention name: Q-NRG+ Indirect Calorimetry Device
description: The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.
arm group label: Q-NRG+ Indirect Calorimetry Device
intervention type: Device
intervention name: V(max) Encore Indirect Calorimetry Device
description: The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.
arm group label: V(max) Encore Indirect Calorimetry Device
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Nilesh M Mehta, MD
role: Study Director
affiliation: Boston Children's Hospital
last name: Ben D Albert, MD
phone: 617-355-7327
email: ben.albert@childrens.harvard.edu
last name: Nilesh M Mehta, MD
phone: 617-355-7327
email: Nilesh.Mehta@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Ben D. Albert, MD
investigator title: Director, Critical Care Medicine Fellowship Program
sharing ipd: No