<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/NCT03823716</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17-00032</org_study_id>
    <nct_id>NCT03823716</nct_id>
  </id_info>
  <brief_title>Inadvertent Hyperventilation During Intraoperative Care in Neonates</brief_title>
  <official_title>Inadvertent Hyperventilation During Intraoperative Care in Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</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 order to evaluate current anesthetic practice in the care of preterm infants and neonates,&#xD;
      the investigators will retrospectively review surgical procedures in infants who are less&#xD;
      than 60 weeks post-conceptual age in which an arterial cannula was placed intraoperatively or&#xD;
      in situ upon arrival in the operating room. They will evaluate the mode of ventilation&#xD;
      (pressure or volume-controlled), tidal volume or peak inflating pressure, the level of PEEP,&#xD;
      inspired oxygen concentration (FiO2), and respiratory rate used during the procedure to&#xD;
      determine the average minute ventilation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">November 8, 2019</completion_date>
  <primary_completion_date type="Actual">November 8, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Decreased Partial Pressure of Carbon Dioxide (PaCO2)</measure>
    <time_frame>During surgical procedure (average of 2-3 hours)</time_frame>
    <description>PaCO2 from arterial blood gas (ABG) ≤ 35</description>
  </primary_outcome>
  <enrollment type="Actual">112</enrollment>
  <condition>Neonatal Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients seen at Nationwide Children's Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  neonates (&lt;60 weeks post-conceptual age) undergoing non-cardiac operative procedures&#xD;
             in which arterial access is generally present (exploratory laparotomy or thoracotomy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>36 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin Chenault, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 14, 2020</last_update_submitted>
  <last_update_submitted_qc>February 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Kristin Chenault</investigator_full_name>
    <investigator_title>Clinical Assistant Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperventilation</mesh_term>
    <mesh_term>Infant, Newborn, Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03823716
org study id: IRB17-00032
nct id: NCT03823716
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In order to evaluate current anesthetic practice in the care of preterm infants and neonates,
      the investigators will retrospectively review surgical procedures in infants who are less
      than 60 weeks post-conceptual age in which an arterial cannula was placed intraoperatively or
      in situ upon arrival in the operating room. They will evaluate the mode of ventilation
      (pressure or volume-controlled), tidal volume or peak inflating pressure, the level of PEEP,
      inspired oxygen concentration (FiO2), and respiratory rate used during the procedure to
      determine the average minute ventilation.
observational model: Cohort
time perspective: Retrospective
measure: Decreased Partial Pressure of Carbon Dioxide (PaCO2)
time frame: During surgical procedure (average of 2-3 hours)
description: PaCO2 from arterial blood gas (ABG) ≤ 35
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 36 Weeks
healthy volunteers: No
last name: Kristin Chenault, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Kristin Chenault
investigator title: Clinical Assistant Professor of Anesthesiology
mesh term: Hyperventilation
mesh term: Infant, Newborn, Diseases