<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/NCT03242733</url>
  </required_header>
  <id_info>
    <org_study_id>20170804/10/2017/8</org_study_id>
    <nct_id>NCT03242733</nct_id>
  </id_info>
  <brief_title>Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip Fracture</brief_title>
  <official_title>Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SMG-SNU Boramae Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SMG-SNU Boramae Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Evaluation of gastric contents in fasted elderly patients with hip fracture. The gastric&#xD;
      contents will be examined by using ultrasonography in fasted elderly patients scheduled for&#xD;
      hip fracture surgery. The primary outcome is the number of patients with stomach contents,&#xD;
      and the secondary outcome is the component of residual gastric contents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the patients who has femur fracture, they are immobilized because of the pain. This&#xD;
      condition makes the gastric movement slow, and the pain also contributes to delayed&#xD;
      digestion.&#xD;
&#xD;
      In the present study, the gastric content is assessed by using ultrasonography in fasted&#xD;
      elderly patients for hip fracture surgery. Ultrasound assessment is performed in the supine&#xD;
      position. All patients scheduled elective surgery for hip fracture over 65 years old are&#xD;
      objects. The primary outcome is the number of patients with not empty stomach and full&#xD;
      stomach, and the secondary outcome is the component of residual gastric contents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 26, 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ultrasound assessment of the presence of gastric contents.</measure>
    <time_frame>Before the induction of anesthesia (Baseline)</time_frame>
    <description>The presence of of gastric contents is assessed by using ultrasonography; yes/no</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasound assessment of the component of residual gastric contents</measure>
    <time_frame>Before the induction of anesthesia (Baseline)</time_frame>
    <description>The component of residual gastric contents is assessed by using ultrasonography; empty, clear fluid, solid content</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>Hip fracture patients</arm_group_label>
    <description>Fasted elderly patients scheduled for hip fracture surgery except exclusion criteria are enrolled.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound assessment of gastric contents</intervention_name>
    <description>Ultrasound assessment of gastric contents is performed in fasted elderly patients for hip fracture surgery.</description>
    <arm_group_label>Hip fracture patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Who has hip fracture and agrees with the purpose of the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Who has hip fracture and agrees with the purpose of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  gastrointestinal pathology&#xD;
&#xD;
          -  history of any type of gastrectomy&#xD;
&#xD;
          -  gastrointestinal anomaly&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Young Hwang, MD,phD</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Boramae Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin-Young Hwang, MD, phD</last_name>
    <phone>82-10-9553-0916</phone>
    <email>mistyblue15@naver.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul Metropolitan Government Seoul National University Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>156-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin-Young Hwang, M.D.</last_name>
      <phone>+82-2-870-2518</phone>
      <email>mistyblue15@naver.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.</citation>
    <PMID>8424572</PMID>
  </reference>
  <reference>
    <citation>Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.</citation>
    <PMID>17122571</PMID>
  </reference>
  <reference>
    <citation>Landreau B, Odin I, Nathan N. [Pulmonary aspiration: epidemiology and risk factors]. Ann Fr Anesth Reanim. 2009 Mar;28(3):206-10. doi: 10.1016/j.annfar.2009.01.020. Epub 2009 Mar 21. French.</citation>
    <PMID>19304443</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>April 20, 2018</last_update_submitted>
  <last_update_submitted_qc>April 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>SMG-SNU Boramae Medical Center</investigator_affiliation>
    <investigator_full_name>Jin-Young Hwang</investigator_full_name>
    <investigator_title>Associate professor, Department of Anesthesiology and Pain medicine</investigator_title>
  </responsible_party>
  <keyword>Gastroparesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <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/NCT03242733
org study id: 20170804/10/2017/8
nct id: NCT03242733
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation of gastric contents in fasted elderly patients with hip fracture. The gastric
      contents will be examined by using ultrasonography in fasted elderly patients scheduled for
      hip fracture surgery. The primary outcome is the number of patients with stomach contents,
      and the secondary outcome is the component of residual gastric contents.
In the patients who has femur fracture, they are immobilized because of the pain. This
      condition makes the gastric movement slow, and the pain also contributes to delayed
      digestion.

      In the present study, the gastric content is assessed by using ultrasonography in fasted
      elderly patients for hip fracture surgery. Ultrasound assessment is performed in the supine
      position. All patients scheduled elective surgery for hip fracture over 65 years old are
      objects. The primary outcome is the number of patients with not empty stomach and full
      stomach, and the secondary outcome is the component of residual gastric contents.
observational model: Cohort
time perspective: Prospective
measure: Ultrasound assessment of the presence of gastric contents.
time frame: Before the induction of anesthesia (Baseline)
description: The presence of of gastric contents is assessed by using ultrasonography; yes/no
measure: Ultrasound assessment of the component of residual gastric contents
time frame: Before the induction of anesthesia (Baseline)
description: The component of residual gastric contents is assessed by using ultrasonography; empty, clear fluid, solid content
arm group label: Hip fracture patients
description: Fasted elderly patients scheduled for hip fracture surgery except exclusion criteria are enrolled.
intervention type: Other
intervention name: Ultrasound assessment of gastric contents
description: Ultrasound assessment of gastric contents is performed in fasted elderly patients for hip fracture surgery.
arm group label: Hip fracture patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Jin-Young Hwang, MD,phD
role: Study Chair
affiliation: Seoul National University Boramae Hospital
last name: Jin-Young Hwang, MD, phD
phone: 82-10-9553-0916
email: mistyblue15@naver.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.
PMID: 8424572
citation: Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
PMID: 17122571
citation: Landreau B, Odin I, Nathan N. [Pulmonary aspiration: epidemiology and risk factors]. Ann Fr Anesth Reanim. 2009 Mar;28(3):206-10. doi: 10.1016/j.annfar.2009.01.020. Epub 2009 Mar 21. French.
PMID: 19304443
responsible party type: Principal Investigator
investigator affiliation: SMG-SNU Boramae Medical Center
investigator full name: Jin-Young Hwang
investigator title: Associate professor, Department of Anesthesiology and Pain medicine
mesh term: Hip Fractures
sharing ipd: No