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/NCT06003985</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0867</org_study_id>
      <nct_id>NCT06003985</nct_id>
    </id_info>
    <brief_title>Gastric Ultrasound Assessment for Patients Taking GLP1 Agonists</brief_title>
    <official_title>Assessment of Preoperative Gastric Content With Ultrasound in Patients Taking GLP1 Agonists</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital for Special Surgery, New York</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital for Special Surgery, New York</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>
        The aim of this study is to perform bedside gastric point of care ultrasound (POCUS) exams to&#xD;
        assess the gastric volume and content (clear liquids vs solid food) perioperatively in&#xD;
        patients who take glucagon-like peptide 1 (GLP-1) agonist medications compared to patients&#xD;
        who do not take GLP-1 agonists.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Glucagon-like peptide 1 (GLP-1) agonists have existed since 2005, however the newer&#xD;
        once-weekly injectable medications particularly semaglutide, and tirzepatide have exploded in&#xD;
        popularity due to their weight loss potential.&#xD;
  &#xD;
        Anesthesiologists nationally have seen an increase in perioperative complications amongst&#xD;
        patients taking these medications due to delayed gastric emptying increasing the risk of&#xD;
        aspiration in the perioperative period. At HSS the majority of our anesthetics are done under&#xD;
        sedation and therefore would not protect the patient from aspiration in the event of&#xD;
        vomiting.&#xD;
  &#xD;
        Protecting patients from aspiration secondary to vomiting during induction or maintenance of&#xD;
        anesthesia has always been an important goal to make anesthesia safer leading to the&#xD;
        development of NPO guidelines which are intended to protect against the presence of gastric&#xD;
        content during anesthetic care. However there is growing concern that patients taking GLP-1&#xD;
        agonists may not be adequately protected using the current nothing by mouth or &quot;NPO&quot;&#xD;
        guidelines. Up to this day there is no literature on how much gastric emptying is delayed&#xD;
        during the use of GLP1 following the standard NPO guidelines.&#xD;
  &#xD;
        Recently Gastric Ultrasound (GUS) has been introduced as a bedside tool for assessing a&#xD;
        patients stomach contents and for the risk of aspiration. Gastric ultrasound can identify an&#xD;
        empty stomach, a stomach filled with clear liquids, thick liquids or solid food content. If a&#xD;
        stomach has clear liquid the volume can be calculated accurately. Generally a stomach with&#xD;
        solid or thick liquid content or with clear liquid measuring more than 1.5 ml/kg body weight&#xD;
        is considered a full stomach. As GUS is noninvasive and well tolerated, it offers the perfect&#xD;
        solution to assessing patient risk in the preoperative period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 29, 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>incidence of delayed gastric emptying</measure>
      <time_frame>This will be measured pre-operatively in the holding room area.</time_frame>
      <description>delayed gastric emptying is defined by the presence of either solid food, thick liquids or a specific volume (&gt;1.5 ml/kg) of clear liquids on gastric ultrasound.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Nothing by mouth (NPO) intervals</measure>
      <time_frame>This will be measured pre-operatively in the holding room area.</time_frame>
      <description>Measure the NPO interval after last solid, liquids, and clears precisely for a subgroup analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Presence of gastric peristalsis</measure>
      <time_frame>This will be measured pre-operatively in the holding room area.</time_frame>
      <description>Gastric peristalsis will be graded as present/ absent on gastric ultrasound</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">314</enrollment>
    <condition>Gastric Ultrasound</condition>
    <condition>Glucagon-like Peptide 1</condition>
    <condition>Point of Care Ultrasound</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <description>The control group will be comprised of patients who are not currently taking any GLP-1 agonist medications. Controls will receive the ultrasound exam to assess stomach contents.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>GLP-1 agonist intake</arm_group_label>
      <description>The GLP-1 agonist intake group will be comprised of patients who are currently taking any GLP-1 agonist medications. This group will receive the ultrasound exam to assess stomach contents.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Gastric Ultrasound Exam</intervention_name>
      <description>A gastric ultrasound is a simple, fast, non-invasive bedside diagnostic test that provides a qualitative and quantitative assessment of gastric contents. There are no known risks of a gastric ultrasound exam.</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>GLP-1 agonist intake</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will be comprised of patients scheduled for surgery at HSS who meet&#xD;
          the following inclusion criteria and none of the exclusion criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  GLP 1 patient group: any patient on GLP1 agonists that are dosed once per week&#xD;
               (semaglutide, dulaglutide, tirzepatide), for all indications.&#xD;
  &#xD;
            -  Control group (No GLP 1 patients): any patient not on GLP1 agonists that are dosed&#xD;
               once per week, for all indications.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patient refusal to participate&#xD;
  &#xD;
            -  patients with gastric bypass or any other gastric surgery&#xD;
  &#xD;
            -  large hiatal hernia&#xD;
  &#xD;
            -  patients with large ascites&#xD;
  &#xD;
            -  patients on peritoneal dialysis&#xD;
  &#xD;
            -  emergency surgery&#xD;
  &#xD;
            -  pre-existing diagnosis of gastroparesis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Oliver Panzer, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital for Special Surgery, Department of Anesthesiology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Miriam Sheetz</last_name>
      <phone>646-714-6685</phone>
      <email>sheetzm@hss.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Oliver Panzer, MD</last_name>
      <phone>(212) 606-1036</phone>
      <email>panzero@hss.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital for Special Surgery</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10021</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Miriam Sheetz, BS</last_name>
        <phone>646-714-6685</phone>
        <email>sheetzm@hss.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Silveira SQ, da Silva LM, de Campos Vieira Abib A, de Moura DTH, de Moura EGH, Santos LB, Ho AM, Nersessian RSF, Lima FLM, Silva MV, Mizubuti GB. Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy. J Clin Anesth. 2023 Aug;87:111091. doi: 10.1016/j.jclinane.2023.111091. Epub 2023 Mar 2.</citation>
      <PMID>36870274</PMID>
    </reference>
    <reference>
      <citation>Maselli DB, Camilleri M. Effects of GLP-1 and Its Analogs on Gastric Physiology in Diabetes Mellitus and Obesity. Adv Exp Med Biol. 2021;1307:171-192. doi: 10.1007/5584_2020_496.</citation>
      <PMID>32077010</PMID>
    </reference>
    <reference>
      <citation>Nakatani Y, Maeda M, Matsumura M, Shimizu R, Banba N, Aso Y, Yasu T, Harasawa H. Effect of GLP-1 receptor agonist on gastrointestinal tract motility and residue rates as evaluated by capsule endoscopy. Diabetes Metab. 2017 Oct;43(5):430-437. doi: 10.1016/j.diabet.2017.05.009. Epub 2017 Jun 23.</citation>
      <PMID>28648835</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>GLP1</keyword>
    <keyword>gastric ultrasound</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06003985
  org study id: 2023-0867
  nct id: NCT06003985
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to perform bedside gastric point of care ultrasound (POCUS) exams to
        assess the gastric volume and content (clear liquids vs solid food) perioperatively in
        patients who take glucagon-like peptide 1 (GLP-1) agonist medications compared to patients
        who do not take GLP-1 agonists.
  Glucagon-like peptide 1 (GLP-1) agonists have existed since 2005, however the newer
        once-weekly injectable medications particularly semaglutide, and tirzepatide have exploded in
        popularity due to their weight loss potential.
  
        Anesthesiologists nationally have seen an increase in perioperative complications amongst
        patients taking these medications due to delayed gastric emptying increasing the risk of
        aspiration in the perioperative period. At HSS the majority of our anesthetics are done under
        sedation and therefore would not protect the patient from aspiration in the event of
        vomiting.
  
        Protecting patients from aspiration secondary to vomiting during induction or maintenance of
        anesthesia has always been an important goal to make anesthesia safer leading to the
        development of NPO guidelines which are intended to protect against the presence of gastric
        content during anesthetic care. However there is growing concern that patients taking GLP-1
        agonists may not be adequately protected using the current nothing by mouth or "NPO"
        guidelines. Up to this day there is no literature on how much gastric emptying is delayed
        during the use of GLP1 following the standard NPO guidelines.
  
        Recently Gastric Ultrasound (GUS) has been introduced as a bedside tool for assessing a
        patients stomach contents and for the risk of aspiration. Gastric ultrasound can identify an
        empty stomach, a stomach filled with clear liquids, thick liquids or solid food content. If a
        stomach has clear liquid the volume can be calculated accurately. Generally a stomach with
        solid or thick liquid content or with clear liquid measuring more than 1.5 ml/kg body weight
        is considered a full stomach. As GUS is noninvasive and well tolerated, it offers the perfect
        solution to assessing patient risk in the preoperative period.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: incidence of delayed gastric emptying
  time frame: This will be measured pre-operatively in the holding room area.
  description: delayed gastric emptying is defined by the presence of either solid food, thick liquids or a specific volume (>1.5 ml/kg) of clear liquids on gastric ultrasound.
  measure: Nothing by mouth (NPO) intervals
  time frame: This will be measured pre-operatively in the holding room area.
  description: Measure the NPO interval after last solid, liquids, and clears precisely for a subgroup analysis.
  measure: Presence of gastric peristalsis
  time frame: This will be measured pre-operatively in the holding room area.
  description: Gastric peristalsis will be graded as present/ absent on gastric ultrasound
  arm group label: Control
  description: The control group will be comprised of patients who are not currently taking any GLP-1 agonist medications. Controls will receive the ultrasound exam to assess stomach contents.
  arm group label: GLP-1 agonist intake
  description: The GLP-1 agonist intake group will be comprised of patients who are currently taking any GLP-1 agonist medications. This group will receive the ultrasound exam to assess stomach contents.
  intervention type: Other
  intervention name: Gastric Ultrasound Exam
  description: A gastric ultrasound is a simple, fast, non-invasive bedside diagnostic test that provides a qualitative and quantitative assessment of gastric contents. There are no known risks of a gastric ultrasound exam.
  arm group label: Control
  arm group label: GLP-1 agonist intake
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Oliver Panzer, MD
  role: Principal Investigator
  affiliation: Hospital for Special Surgery, Department of Anesthesiology
  last name: Miriam Sheetz
  phone: 646-714-6685
  email: sheetzm@hss.edu
  last name: Oliver Panzer, MD
  phone: (212) 606-1036
  email: panzero@hss.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  citation: Silveira SQ, da Silva LM, de Campos Vieira Abib A, de Moura DTH, de Moura EGH, Santos LB, Ho AM, Nersessian RSF, Lima FLM, Silva MV, Mizubuti GB. Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy. J Clin Anesth. 2023 Aug;87:111091. doi: 10.1016/j.jclinane.2023.111091. Epub 2023 Mar 2.
  PMID: 36870274
  citation: Maselli DB, Camilleri M. Effects of GLP-1 and Its Analogs on Gastric Physiology in Diabetes Mellitus and Obesity. Adv Exp Med Biol. 2021;1307:171-192. doi: 10.1007/5584_2020_496.
  PMID: 32077010
  citation: Nakatani Y, Maeda M, Matsumura M, Shimizu R, Banba N, Aso Y, Yasu T, Harasawa H. Effect of GLP-1 receptor agonist on gastrointestinal tract motility and residue rates as evaluated by capsule endoscopy. Diabetes Metab. 2017 Oct;43(5):430-437. doi: 10.1016/j.diabet.2017.05.009. Epub 2017 Jun 23.
  PMID: 28648835
  responsible party type: Sponsor
  sharing ipd: No