<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/NCT02239068</url>
  </required_header>
  <id_info>
    <org_study_id>2011-0286</org_study_id>
    <nct_id>NCT02239068</nct_id>
  </id_info>
  <brief_title>CT Residual Gastric Fluid Volume</brief_title>
  <official_title>Residual Gastric Fluid With Administering Clear Liquids Within Two Hours of Anesthesia in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis: The investigators hypothesize that more than 50% of the patients receiving&#xD;
      enteric contrast material (ECM) &lt; 2 hours of anesthesia/sedation would have residual gastric&#xD;
      fluid volume (GFV) &gt; 0.4 ml/kg. The investigators also hypothesize that measuring GFV by&#xD;
      using region of interest in the CT technique is accurate compared to blind aspiration of the&#xD;
      gastric contents with a syringe and a multi-orificed orogastric tube.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of our study is to examine the residual gastric fluid volume when oral contrast&#xD;
      is administered within 2 hours of anesthesia /sedation and to validate the accuracy of&#xD;
      measuring the residual gastric volume by using region of interest in the CT image by using&#xD;
      blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Residual gastric fluid volume (GFV) &lt; 0.4ml/kg or &gt; 0.4 ml/kg</measure>
    <time_frame>Approximately 2 hours</time_frame>
    <description>Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Residual gastric fluid volume (GFV) &lt; 0.8 ml/kg or &gt; 0.8 ml/kg</measure>
    <time_frame>Approximate 2 hours</time_frame>
    <description>Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Clinical CT Abdomen/Pelvic With Oral Contrast and Sedation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited from the Radiology CT schedule.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for CT abdomen with contrast and require anesthesia/sedation&#xD;
&#xD;
          -  Subjects must be 1 month to 10 years of age (inclusive)&#xD;
&#xD;
          -  The subject's legally authorized representative has given written informed consent to&#xD;
             participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects violate the institution fasting guideline before anesthesia /sedation with&#xD;
             the exception of the oral contrast&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Mahmoud, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>March 20, 2023</last_update_submitted>
  <last_update_submitted_qc>March 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CT, sedation, oral contrast</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/NCT02239068
org study id: 2011-0286
nct id: NCT02239068
lead sponsor: 
has dmc: No
Hypothesis: The investigators hypothesize that more than 50% of the patients receiving
      enteric contrast material (ECM) < 2 hours of anesthesia/sedation would have residual gastric
      fluid volume (GFV) > 0.4 ml/kg. The investigators also hypothesize that measuring GFV by
      using region of interest in the CT technique is accurate compared to blind aspiration of the
      gastric contents with a syringe and a multi-orificed orogastric tube.
The purpose of our study is to examine the residual gastric fluid volume when oral contrast
      is administered within 2 hours of anesthesia /sedation and to validate the accuracy of
      measuring the residual gastric volume by using region of interest in the CT image by using
      blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.
observational model: Case-Only
time perspective: Prospective
measure: Residual gastric fluid volume (GFV) < 0.4ml/kg or > 0.4 ml/kg
time frame: Approximately 2 hours
description: Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study.
measure: Residual gastric fluid volume (GFV) < 0.8 ml/kg or > 0.8 ml/kg
time frame: Approximate 2 hours
description: Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed Mahmoud, MD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No