<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/NCT03758313</url>
  </required_header>
  <id_info>
    <org_study_id>1173/2018</org_study_id>
    <nct_id>NCT03758313</nct_id>
  </id_info>
  <brief_title>Non-Invasive Monitoring of Partial Pressure of Carbon Dioxide in Mechanically Ventilated Preterm Infants</brief_title>
  <official_title>Non-Invasive Monitoring of Partial Pressure of Carbon Dioxide in Mechanically Ventilated Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tobias Werther</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      In mechanically ventilated preterm infants, the ability to monitor carbon dioxide partial&#xD;
      pressure (pCO2) values is indispensable. The gold standard for pCO2 measurement is from an&#xD;
      arterial blood sample (paCO2). This has two drawbacks: firstly, it requires an arterial line&#xD;
      and, secondly, it does not provide the clinicians with a continuous measurement. At present,&#xD;
      two alternative pCO2 monitoring systems are available in the field of neonatal intensive care&#xD;
      medicine: end-tidal CO2 (etCO2) capnography and transcutaneous CO2 (tcCO2) measurements. Both&#xD;
      methods have disadvantages including potential technical errors as well as pathologies that&#xD;
      may reduce reliability as a surrogate for blood gas analysis (BGA). In particular,&#xD;
      conventional side-stream etCO2 capnography underestimates pCO2 in presence of a tube leakage,&#xD;
      which is a common occurrence in ventilated preterm infants where only tubes without cuff are&#xD;
      used. Distal etCO2 (detCO2) by means of a double lumen endo-tracheal tube may solve the&#xD;
      problem of unreliable etCO2 values in the presence of tube leakage.&#xD;
&#xD;
      The aim of this study is to compare the agreement, precision and repeatability of the distal&#xD;
      etCO2-measurement technique described by Kugelman et al. with respect to paCO2 and tcCO2 in&#xD;
      mechanically ventilated preterm infants. Since ventilation strategies and pCO2 limits may&#xD;
      vary among different centers, this study helps to determine which non-invasive CO2 monitoring&#xD;
      system (detCO2 or tcO2) is more suitable in terms of applicability and reliability in preterm&#xD;
      infants at our neonatal intensive care units.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: In mechanically ventilated preterm infants, the ability to monitor carbon dioxide&#xD;
      partial pressure (pCO2) values is indispensable. The gold standard for pCO2 measurement is&#xD;
      from an arterial blood sample (paCO2). This has two drawbacks: firstly, it requires an&#xD;
      arterial line and, secondly, it does not provide the clinicians with a continuous&#xD;
      measurement. At present, two alternative pCO2 monitoring systems are available in the field&#xD;
      of neonatal intensive care medicine: end-tidal CO2 (etCO2) capnography and transcutaneous CO2&#xD;
      (tcCO2) measurements. Both methods have disadvantages including potential technical errors as&#xD;
      well as pathologies that may reduce reliability as a surrogate for blood gas analysis (BGA).&#xD;
      In particular, conventional side-stream etCO2 capnography underestimates pCO2 in presence of&#xD;
      a tube leakage, which is a common occurrence in ventilated preterm infants where only tubes&#xD;
      without cuff are used. Distal etCO2 (detCO2) by means of a double lumen endo-tracheal tube&#xD;
      may solve the problem of unreliable etCO2 values in the presence of tube leakage.&#xD;
&#xD;
      Several studies compared etCO2 and tcCO2 to paCO2, simultaneously. A comparison study of&#xD;
      etCO2 and tcCO2 in a cohort of critically ill children did not reveal significant differences&#xD;
      in the absence of severe pulmonary parenchymal disease. Tobias et al compared etCO2 and tcCO2&#xD;
      in a cohort of pediatric intensive care patients with respiratory failure and found tcCO2&#xD;
      measurements to be more accurate. In a cohort of ventilated newborns, tcCO2 monitoring was&#xD;
      generally more precise than etCO2 during neonatal transport to monitor ventilation. In a more&#xD;
      recent study restricted to a cohort of postsurgical neonates without lung disease, etCO2&#xD;
      underestimated paCO2 more than tcCO2 but provided greater precision over paCO2, however it&#xD;
      was less accurate at smaller tidal volumes. These studies have in common that the adapter of&#xD;
      the pCO2 analyzer was attached in-line and proximal to the endotracheal tube.&#xD;
&#xD;
      Aim of the study: The aim of this study is to compare the agreement, precision and&#xD;
      repeatability of the distal etCO2-measurement technique described by Kugelman et al. with&#xD;
      respect to paCO2 and tcCO2 in mechanically ventilated preterm infants. Since ventilation&#xD;
      strategies and pCO2 limits may vary among different centers, this study helps to determine&#xD;
      which non-invasive CO2 monitoring system (detCO2 or tcO2) is more suitable in terms of&#xD;
      applicability and reliability in preterm infants at our neonatal intensive care units.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 26, 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>Carbon Dioxide in Mechanically Ventilated Preterm Infants</measure>
    <time_frame>48 hours</time_frame>
    <description>partial pressure of carbon dioxide</description>
  </primary_outcome>
  <enrollment type="Actual">27</enrollment>
  <condition>Preterm Infant</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CO2 measurements</intervention_name>
    <description>Distal etCO2, tcCO2 and paCO2 values will be recorded simultaneously in ventilated preterm infants. We will measure etCO2 in a distal position using a double lumen tube connected to an external side-stream capnometer.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Mechanically Ventilated Preterm Infants&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preterm infants with a current body weight between 1000 g and 3000 g who require&#xD;
             intubation.&#xD;
&#xD;
          -  Signed informed consent from parents or legal guardians.&#xD;
&#xD;
          -  Expected to provide at least three measurements of paCO2 and detCO2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with known congenital anomalies of the heart and/or lung.&#xD;
&#xD;
          -  Need for high frequency oscillation.&#xD;
&#xD;
          -  Parents or legal guardians deny informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tobias Werther, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Pediatrics, Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
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  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>August 15, 2021</last_update_submitted>
  <last_update_submitted_qc>August 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Tobias Werther</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT03758313
org study id: 1173/2018
nct id: NCT03758313
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In mechanically ventilated preterm infants, the ability to monitor carbon dioxide partial
      pressure (pCO2) values is indispensable. The gold standard for pCO2 measurement is from an
      arterial blood sample (paCO2). This has two drawbacks: firstly, it requires an arterial line
      and, secondly, it does not provide the clinicians with a continuous measurement. At present,
      two alternative pCO2 monitoring systems are available in the field of neonatal intensive care
      medicine: end-tidal CO2 (etCO2) capnography and transcutaneous CO2 (tcCO2) measurements. Both
      methods have disadvantages including potential technical errors as well as pathologies that
      may reduce reliability as a surrogate for blood gas analysis (BGA). In particular,
      conventional side-stream etCO2 capnography underestimates pCO2 in presence of a tube leakage,
      which is a common occurrence in ventilated preterm infants where only tubes without cuff are
      used. Distal etCO2 (detCO2) by means of a double lumen endo-tracheal tube may solve the
      problem of unreliable etCO2 values in the presence of tube leakage.

      The aim of this study is to compare the agreement, precision and repeatability of the distal
      etCO2-measurement technique described by Kugelman et al. with respect to paCO2 and tcCO2 in
      mechanically ventilated preterm infants. Since ventilation strategies and pCO2 limits may
      vary among different centers, this study helps to determine which non-invasive CO2 monitoring
      system (detCO2 or tcO2) is more suitable in terms of applicability and reliability in preterm
      infants at our neonatal intensive care units.
Background: In mechanically ventilated preterm infants, the ability to monitor carbon dioxide
      partial pressure (pCO2) values is indispensable. The gold standard for pCO2 measurement is
      from an arterial blood sample (paCO2). This has two drawbacks: firstly, it requires an
      arterial line and, secondly, it does not provide the clinicians with a continuous
      measurement. At present, two alternative pCO2 monitoring systems are available in the field
      of neonatal intensive care medicine: end-tidal CO2 (etCO2) capnography and transcutaneous CO2
      (tcCO2) measurements. Both methods have disadvantages including potential technical errors as
      well as pathologies that may reduce reliability as a surrogate for blood gas analysis (BGA).
      In particular, conventional side-stream etCO2 capnography underestimates pCO2 in presence of
      a tube leakage, which is a common occurrence in ventilated preterm infants where only tubes
      without cuff are used. Distal etCO2 (detCO2) by means of a double lumen endo-tracheal tube
      may solve the problem of unreliable etCO2 values in the presence of tube leakage.

      Several studies compared etCO2 and tcCO2 to paCO2, simultaneously. A comparison study of
      etCO2 and tcCO2 in a cohort of critically ill children did not reveal significant differences
      in the absence of severe pulmonary parenchymal disease. Tobias et al compared etCO2 and tcCO2
      in a cohort of pediatric intensive care patients with respiratory failure and found tcCO2
      measurements to be more accurate. In a cohort of ventilated newborns, tcCO2 monitoring was
      generally more precise than etCO2 during neonatal transport to monitor ventilation. In a more
      recent study restricted to a cohort of postsurgical neonates without lung disease, etCO2
      underestimated paCO2 more than tcCO2 but provided greater precision over paCO2, however it
      was less accurate at smaller tidal volumes. These studies have in common that the adapter of
      the pCO2 analyzer was attached in-line and proximal to the endotracheal tube.

      Aim of the study: The aim of this study is to compare the agreement, precision and
      repeatability of the distal etCO2-measurement technique described by Kugelman et al. with
      respect to paCO2 and tcCO2 in mechanically ventilated preterm infants. Since ventilation
      strategies and pCO2 limits may vary among different centers, this study helps to determine
      which non-invasive CO2 monitoring system (detCO2 or tcO2) is more suitable in terms of
      applicability and reliability in preterm infants at our neonatal intensive care units.
observational model: Cohort
time perspective: Prospective
measure: Carbon Dioxide in Mechanically Ventilated Preterm Infants
time frame: 48 hours
description: partial pressure of carbon dioxide
intervention type: Other
intervention name: CO2 measurements
description: Distal etCO2, tcCO2 and paCO2 values will be recorded simultaneously in ventilated preterm infants. We will measure etCO2 in a distal position using a double lumen tube connected to an external side-stream capnometer.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Tobias Werther, PhD
role: Principal Investigator
affiliation: Medical University Vienna
facility: 
country: Austria
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responsible party type: Sponsor-Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Tobias Werther
investigator title: Dr.
mesh term: Premature Birth
sharing ipd: Undecided