<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/NCT03017066</url>
  </required_header>
  <id_info>
    <org_study_id>1612100815</org_study_id>
    <nct_id>NCT03017066</nct_id>
  </id_info>
  <brief_title>Ultrasound Assessment of Preoperative Gastric Volume in Children</brief_title>
  <official_title>Ultrasound Assessment of Gastric Volume Following Preoperative Fasting Guideline in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      The purpose of this study is to compare the gastric volume in pediatric patients who followed&#xD;
      preoperative fasting guideline using ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2017</start_date>
  <completion_date type="Actual">April 20, 2019</completion_date>
  <primary_completion_date type="Actual">April 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intra-group difference between gastric volume measured on second and third ultrasound assessment</measure>
    <time_frame>Interval between second and third ultrasound assessment, an expected average of 1 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inter-group difference in gastric volume at each time point</measure>
    <time_frame>From 6 hours prior to surgery to the induction of general anesthesia, an expected average of 6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative incidence of nausea, vomiting, fever, and respiratory complications</measure>
    <time_frame>From the induction of general anesthesia until postoperative 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of patient's preoperative anxiety, scored from 0 to 10, with 0 being good and 10 being bad</measure>
    <time_frame>From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of patient's preoperative hunger, scored from 0 to 10, with 0 being good and 10 being bad</measure>
    <time_frame>From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of patient's preoperative nausea, scored from 0 to 10, with 0 being good and 10 being bad</measure>
    <time_frame>From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of patient's preoperative thirst, scored from 0 to 10, with 0 being good and 10 being bad</measure>
    <time_frame>From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of patient's preoperative weakness, scored from 0 to 10, with 0 being good and 10 being bad</measure>
    <time_frame>From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of patient's preoperative irritability, scored from 0 to 10, with 0 being good and 10 being bad</measure>
    <time_frame>From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of parent's satisfaction, scored from 0 to 10, with 0 being satisfied and 10 being unsatisfied</measure>
    <time_frame>From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Fasting</condition>
  <arm_group>
    <arm_group_label>Infant formula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were given infant formula 6 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carbohydrate drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were given carbohydrate drink 2 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Ultrasound assessment of gastric volume is performed three times; before ingestion of infant formula or carbohydrate drink; 1 hour prior to the surgery; and before induction of general anesthesia.</description>
    <arm_group_label>Carbohydrate drink</arm_group_label>
    <arm_group_label>Infant formula</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>General anesthesia</intervention_name>
    <description>Scheduled operation under general anesthesia</description>
    <arm_group_label>Carbohydrate drink</arm_group_label>
    <arm_group_label>Infant formula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Pediatric patients scheduled for elective orthopedic, otolaryngologic, ophthalmologic,&#xD;
        plastic, and urologic surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of surgery on the esophagus or stomach&#xD;
&#xD;
          -  History of gastrointestinal disease&#xD;
&#xD;
          -  Ambulatory surgery&#xD;
&#xD;
          -  Considered inappropriate by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Tae Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.</citation>
    <PMID>19512861</PMID>
  </reference>
  <reference>
    <citation>Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.</citation>
    <PMID>21364462</PMID>
  </reference>
  <reference>
    <citation>Fukunaga C, Sugita M, Yamamoto T. Validity of ultrasonographic measurement of gastric volume in fasted pediatric patients without sedation. J Anesth. 2016 Oct;30(5):900-3. doi: 10.1007/s00540-016-2204-3. Epub 2016 Jun 22.</citation>
    <PMID>27334390</PMID>
  </reference>
  <reference>
    <citation>American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.</citation>
    <PMID>21307770</PMID>
  </reference>
  <reference>
    <citation>Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.</citation>
    <PMID>21712716</PMID>
  </reference>
  <reference>
    <citation>Brady M, Kinn S, Ness V, O'Rourke K, Randhawa N, Stuart P. Preoperative fasting for preventing perioperative complications in children. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD005285. doi: 10.1002/14651858.CD005285.pub2.</citation>
    <PMID>19821343</PMID>
  </reference>
  <reference>
    <citation>Brunet-Wood K, Simons M, Evasiuk A, Mazurak V, Dicken B, Ridley D, Larsen B. Surgical fasting guidelines in children: Are we putting them into practice? J Pediatr Surg. 2016 Aug;51(8):1298-302. doi: 10.1016/j.jpedsurg.2016.04.006. Epub 2016 Apr 21.</citation>
    <PMID>27166876</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>September 17, 2020</last_update_submitted>
  <last_update_submitted_qc>September 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin-Tae Kim</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Ultrasonography</keyword>
  <keyword>Child</keyword>
  <keyword>Preoperative period</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT03017066
org study id: 1612100815
nct id: NCT03017066
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the gastric volume in pediatric patients who followed
      preoperative fasting guideline using ultrasound.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Intra-group difference between gastric volume measured on second and third ultrasound assessment
time frame: Interval between second and third ultrasound assessment, an expected average of 1 hour
measure: Inter-group difference in gastric volume at each time point
time frame: From 6 hours prior to surgery to the induction of general anesthesia, an expected average of 6 hours
measure: Perioperative incidence of nausea, vomiting, fever, and respiratory complications
time frame: From the induction of general anesthesia until postoperative 24 hours
measure: Degree of patient's preoperative anxiety, scored from 0 to 10, with 0 being good and 10 being bad
time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
measure: Degree of patient's preoperative hunger, scored from 0 to 10, with 0 being good and 10 being bad
time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
measure: Degree of patient's preoperative nausea, scored from 0 to 10, with 0 being good and 10 being bad
time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
measure: Degree of patient's preoperative thirst, scored from 0 to 10, with 0 being good and 10 being bad
time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
measure: Degree of patient's preoperative weakness, scored from 0 to 10, with 0 being good and 10 being bad
time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
measure: Degree of patient's preoperative irritability, scored from 0 to 10, with 0 being good and 10 being bad
time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
measure: Degree of parent's satisfaction, scored from 0 to 10, with 0 being satisfied and 10 being unsatisfied
time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
arm group label: Infant formula
arm group type: Experimental
description: Patients were given infant formula 6 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.
arm group label: Carbohydrate drink
arm group type: Experimental
description: Patients were given carbohydrate drink 2 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.
intervention type: Device
intervention name: Ultrasound
description: Ultrasound assessment of gastric volume is performed three times; before ingestion of infant formula or carbohydrate drink; 1 hour prior to the surgery; and before induction of general anesthesia.
arm group label: Carbohydrate drink
arm group label: Infant formula
intervention type: Other
intervention name: General anesthesia
description: Scheduled operation under general anesthesia
arm group label: Carbohydrate drink
arm group label: Infant formula
criteria: 
gender: All
minimum age: N/A
maximum age: 7 Years
healthy volunteers: No
last name: Jin-Tae Kim
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
citation: Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.
PMID: 19512861
citation: Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
PMID: 21364462
citation: Fukunaga C, Sugita M, Yamamoto T. Validity of ultrasonographic measurement of gastric volume in fasted pediatric patients without sedation. J Anesth. 2016 Oct;30(5):900-3. doi: 10.1007/s00540-016-2204-3. Epub 2016 Jun 22.
PMID: 27334390
citation: American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.
PMID: 21307770
citation: Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
PMID: 21712716
citation: Brady M, Kinn S, Ness V, O'Rourke K, Randhawa N, Stuart P. Preoperative fasting for preventing perioperative complications in children. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD005285. doi: 10.1002/14651858.CD005285.pub2.
PMID: 19821343
citation: Brunet-Wood K, Simons M, Evasiuk A, Mazurak V, Dicken B, Ridley D, Larsen B. Surgical fasting guidelines in children: Are we putting them into practice? J Pediatr Surg. 2016 Aug;51(8):1298-302. doi: 10.1016/j.jpedsurg.2016.04.006. Epub 2016 Apr 21.
PMID: 27166876
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin-Tae Kim
investigator title: Associate professor
mesh term: Anesthetics
sharing ipd: No