xml: <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/NCT06038734</url>
    </required_header>
    <id_info>
      <org_study_id>23-0578</org_study_id>
      <nct_id>NCT06038734</nct_id>
    </id_info>
    <brief_title>Using Point-of-Care-Ultrasound (POCUS) to Assess Gastric Contents Among Fasting Pre-operative Patients Taking GLP-1 Agonists.</brief_title>
    <official_title>Using Point-of-Care-Ultrasound (POCUS) to Assess Gastric Contents Among Fasting Pre-operative Patients Taking GLP-1 Agonists.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of North Carolina, Chapel Hill</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Given the increased prescription of GLP-1 agonists for both diabetes and obesity management&#xD;
        and the implications of the proposed delayed gastric emptying in the setting of an&#xD;
        anesthetic, it is critical to determine if patients taking GLP-1 agonists have an increased&#xD;
        rate of delayed gastric emptying. The purpose of this prospective gastric ultrasound&#xD;
        evaluation of pre-operative patients is to determine the incidence of a full stomach despite&#xD;
        a standard pre-operative fasting period.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Retained gastric contents</measure>
      <time_frame>At time of pre-operative assessment</time_frame>
      <description>Presence of retained gastric contents, either liquid or solid</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Delayed Gastric Emptying</condition>
    <condition>Gastroparesis</condition>
    <arm_group>
      <arm_group_label>GLP-1 agonists</arm_group_label>
      <description>Pre-operative gastric ultrasound to evaluate for retained gastric contents in appropriately fasted patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>gastric ultrasound</intervention_name>
      <description>Utilize POC gastric ultrasound to identify the presence of retained gastric contents.</description>
      <arm_group_label>GLP-1 agonists</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will include non-critically ill adults 18 years and older undergoing&#xD;
          various elective surgical procedures at the University of North Carolina Medical Center&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  GLP-1 agonist use within previous 30 days&#xD;
  &#xD;
            -  Appropriately fasted per standard guidelines&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of gastric surgery / gastric volume reduction&#xD;
  &#xD;
            -  Critical illness&#xD;
  &#xD;
            -  Inability to provide informed consent&#xD;
  &#xD;
            -  &lt;18 years of age&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lindsey Gouker, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of North Carolina, Chapel Hill</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lindsey Gouker, MD</last_name>
      <phone>3038851340</phone>
      <email>lindsey_gouker@med.unc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of North Carolina Medical Center</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27514</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lindsey Gouker, MD</last_name>
        <phone>303-885-1340</phone>
        <email>lindsey_gouker@med.unc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>GLP-1 agonists</keyword>
    <keyword>retained gastric contents</keyword>
    <keyword>glucagon-like peptide receptor-1 agonists</keyword>
    <keyword>perioperative</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastroparesis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Beginning 9 and continuing for 36 months following publication</ipd_time_frame>
      <ipd_access_criteria>Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038734
  org study id: 23-0578
  nct id: NCT06038734
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Given the increased prescription of GLP-1 agonists for both diabetes and obesity management
        and the implications of the proposed delayed gastric emptying in the setting of an
        anesthetic, it is critical to determine if patients taking GLP-1 agonists have an increased
        rate of delayed gastric emptying. The purpose of this prospective gastric ultrasound
        evaluation of pre-operative patients is to determine the incidence of a full stomach despite
        a standard pre-operative fasting period.
  observational model: Cohort
  time perspective: Prospective
  measure: Retained gastric contents
  time frame: At time of pre-operative assessment
  description: Presence of retained gastric contents, either liquid or solid
  arm group label: GLP-1 agonists
  description: Pre-operative gastric ultrasound to evaluate for retained gastric contents in appropriately fasted patients
  intervention type: Diagnostic Test
  intervention name: gastric ultrasound
  description: Utilize POC gastric ultrasound to identify the presence of retained gastric contents.
  arm group label: GLP-1 agonists
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lindsey Gouker, MD
  role: Principal Investigator
  affiliation: University of North Carolina, Chapel Hill
  last name: Lindsey Gouker, MD
  phone: 3038851340
  email: lindsey_gouker@med.unc.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Gastroparesis
  sharing ipd: Yes
  ipd description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Beginning 9 and continuing for 36 months following publication
  ipd access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.