<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/NCT04478435</url>
  </required_header>
  <id_info>
    <org_study_id>FF-2018-447</org_study_id>
    <nct_id>NCT04478435</nct_id>
  </id_info>
  <brief_title>Gastric Volume Estimation by Ultrasonography After Glucose Loaded Clear Fluid Ingestion in Fasted Adult</brief_title>
  <official_title>The Comparative Gastric Volume Estimation Between Different Time Intervals by Ultrasonography After Glucose Loaded Clear Fluid Ingestion in Fasted Healthy Adult</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Kebangsaan Malaysia Medical Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiti Kebangsaan Malaysia Medical Centre</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction; Pre operative gastric ultrasonography is a newly developed tool used to&#xD;
      evaluate gastric content and volume in assessing perioperative aspiration risk and guide&#xD;
      anaesthetic management. Gastric antrum is the most amenable and most consistently identified&#xD;
      region for sonographic examination during assessment even in empty state. Baseline gastric&#xD;
      secretions and clear fluids i.e: water, apple juice and tea have hypoechoeic or anechoic&#xD;
      appearance, whilst milk, thick fluids, or suspensions will have increased echogenicity.&#xD;
      Evaluation with sonographic assessment were found to be accurately reflective of gastric&#xD;
      content in various studies.&#xD;
&#xD;
      In this study, healthy volunteers were recruited. They will be required to fast at least 8&#xD;
      hours prior to baseline gastric antrum ultrasonography assessment. Following that, they will&#xD;
      require to drink 250ml glucose loaded drinks. Repeated Ultrasound assessment will be done&#xD;
      after 1 hour of glucose loaded drink ingestion in Group 1 and after 2 hours in Group 2.&#xD;
      Hypothesis of the study is there will be no significant different between ultrasound&#xD;
      assessment between this 2 groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective randomized controlled trial study will be conducted in the Department of&#xD;
      Anaesthesiology and Intensive Care UKM for eight months period from November 2018 to June&#xD;
      2019 involving healthy adult volunteers comprising staff members of Department of&#xD;
      Anaesthesiology and Intensive Care, after obtaining approval from Research Committee of the&#xD;
      Department of Anaesthesiology &amp; Intensive Care, Hospital Canselor Tuanku Muhriz, Universiti&#xD;
      Kebangsaan Malaysia Medical Centre (UKMMC) and the Medical Research &amp; Ethics Committee,&#xD;
      UKMMC. Written informed consent will be obtained from volunteers who fulfill the inclusion&#xD;
      criteria.&#xD;
&#xD;
      All volunteers will be fasted, a minimum of 8 hours (duration of fasting will be recorded&#xD;
      before the study begin) and will undergo baseline ultrasonographic gastric assessment (t0).&#xD;
&#xD;
      All subjects in Group 1 and group 2 will drink 250 ml of lychee juice (glucose loaded clear&#xD;
      fluid containing solution with lychee flavor; 145 kcal in 250 ml) after completion of&#xD;
      baseline gastric assessment.&#xD;
&#xD;
      Group 1 subjects will then continue fasting for one hour until completion of second&#xD;
      sonographic antral assessment. Subjects in Group 2 will continue fasting for 2 hours until&#xD;
      second sonographic antral assessment scan is completed.&#xD;
&#xD;
      Subjects will be divided into 2 groups via computer randomization which will be allocated by&#xD;
      anaesthesia trainee that will not be taking part in the analytical and further write up&#xD;
      phases of the study. Ultrasonographic volume assessment will be conducted by a single&#xD;
      operator who is an anaesthesia Masters trainee, experienced in diagnostic abdominal&#xD;
      ultrasound with more than 20 sonographic gastric volume assessments. The images will be&#xD;
      recorded and validated by a consultant radiologist.&#xD;
&#xD;
      Ultrasonographic views of antral area will be obtained using a curvilinear array 2- to 5-MHz&#xD;
      transducer and a Mindray DC-70 (Shanghai, China) with image compounding technologies. Images&#xD;
      will be obtained with the stomach at rest, and between peristaltic contractions. Sonograms of&#xD;
      the antral area will be examined in 2 views, cross-section in the supine position, followed&#xD;
      by the right lateral decubitus position, at each of the two scanning sessions.&#xD;
&#xD;
      During ultrasonography, the antrum will be imaged in a parasagittal plane in the epigastric&#xD;
      area using the left lobe of the liver, the inferior vena cava, and the superior mesenteric&#xD;
      vein as internal landmarks. The two vessels are usually visualized slightly to the right of&#xD;
      the abdominal midline. Once these vessels were identified, the transducer will be rotated&#xD;
      slightly clockwise or counterclockwise to best obtain a true cross-sectional view of the&#xD;
      antrum. The anteroposterior and craniocaudal diameters will be measured in this view.&#xD;
&#xD;
      CSA of the antral area (a two-dimensional section) will be calculated according to the&#xD;
      formula previously used by Bolondi18 using two maximum perpendicular diameters.&#xD;
&#xD;
      This formula essentially represents the surface area of an ellipse, as follows: CSA (AP x CC&#xD;
      x pie/4), where AP is the anteroposterior diameter and CC is the craniocaudal diameter&#xD;
      measures in one decimal point.&#xD;
&#xD;
      Estimation of gastric volume will be obtain using this formula:&#xD;
&#xD;
      Predicted gastric volume based on right lateral CSA value : 27 + 14.6 * right lat CSA -&#xD;
      1.28*age (negative volume value indicates and empty state).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastric volume assessment</measure>
    <time_frame>1 hour after intervention</time_frame>
    <description>Gastric volume can be calculated with gastric antrum measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastric volume assessment</measure>
    <time_frame>2 hours after intervention</time_frame>
    <description>Gastric volume can be calculated with gastric antrum measurement</description>
  </primary_outcome>
  <other_outcome>
    <measure>Baseline gastric volume</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline gastric volume assessed prior to ingestion of glucose loaded clear fluid</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">254</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>1 Hour post intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound assessment done 1 hour after ingestion of glucose loaded drink</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 hours post intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Ultrasound assessment done 2 hour after ingestion of glucose loaded drink</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>glucose loaded clear fluid</intervention_name>
    <description>Ultrasound assessment of gastric antrum is done at different time interval following glucose loaded clear fluid ingestion</description>
    <arm_group_label>1 Hour post intervention</arm_group_label>
    <arm_group_label>2 hours post intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1 &amp; 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Upper gastrointestinal pathology such as hiatus hernia, oesophageal cancer&#xD;
&#xD;
          -  Prior surgery to upper GI&#xD;
&#xD;
          -  On medication that may affect gastric emptying time&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Syarifah Noor Nazihah S Masri</last_name>
    <role>Principal Investigator</role>
    <affiliation>PPUKM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pusat Perubatan Universiti Kebangsaan Malaysia</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>Wp</state>
        <zip>5600</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Read MS, Vaughan RS. Allowing pre-operative patients to drink: effects on patients' safety and comfort of unlimited oral water until 2 hours before anaesthesia. Acta Anaesthesiol Scand. 1991 Oct;35(7):591-5. doi: 10.1111/j.1399-6576.1991.tb03354.x.</citation>
    <PMID>1785235</PMID>
  </results_reference>
  <results_reference>
    <citation>Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19.</citation>
    <PMID>21596885</PMID>
  </results_reference>
  <results_reference>
    <citation>Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.</citation>
    <PMID>29624530</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastric antrum ultrasonography</keyword>
  <keyword>Gastric volume estimation</keyword>
  <keyword>aspiration risk</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will be share on request</ipd_description>
  </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/NCT04478435
org study id: FF-2018-447
nct id: NCT04478435
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Introduction; Pre operative gastric ultrasonography is a newly developed tool used to
      evaluate gastric content and volume in assessing perioperative aspiration risk and guide
      anaesthetic management. Gastric antrum is the most amenable and most consistently identified
      region for sonographic examination during assessment even in empty state. Baseline gastric
      secretions and clear fluids i.e: water, apple juice and tea have hypoechoeic or anechoic
      appearance, whilst milk, thick fluids, or suspensions will have increased echogenicity.
      Evaluation with sonographic assessment were found to be accurately reflective of gastric
      content in various studies.

      In this study, healthy volunteers were recruited. They will be required to fast at least 8
      hours prior to baseline gastric antrum ultrasonography assessment. Following that, they will
      require to drink 250ml glucose loaded drinks. Repeated Ultrasound assessment will be done
      after 1 hour of glucose loaded drink ingestion in Group 1 and after 2 hours in Group 2.
      Hypothesis of the study is there will be no significant different between ultrasound
      assessment between this 2 groups.
This prospective randomized controlled trial study will be conducted in the Department of
      Anaesthesiology and Intensive Care UKM for eight months period from November 2018 to June
      2019 involving healthy adult volunteers comprising staff members of Department of
      Anaesthesiology and Intensive Care, after obtaining approval from Research Committee of the
      Department of Anaesthesiology & Intensive Care, Hospital Canselor Tuanku Muhriz, Universiti
      Kebangsaan Malaysia Medical Centre (UKMMC) and the Medical Research & Ethics Committee,
      UKMMC. Written informed consent will be obtained from volunteers who fulfill the inclusion
      criteria.

      All volunteers will be fasted, a minimum of 8 hours (duration of fasting will be recorded
      before the study begin) and will undergo baseline ultrasonographic gastric assessment (t0).

      All subjects in Group 1 and group 2 will drink 250 ml of lychee juice (glucose loaded clear
      fluid containing solution with lychee flavor; 145 kcal in 250 ml) after completion of
      baseline gastric assessment.

      Group 1 subjects will then continue fasting for one hour until completion of second
      sonographic antral assessment. Subjects in Group 2 will continue fasting for 2 hours until
      second sonographic antral assessment scan is completed.

      Subjects will be divided into 2 groups via computer randomization which will be allocated by
      anaesthesia trainee that will not be taking part in the analytical and further write up
      phases of the study. Ultrasonographic volume assessment will be conducted by a single
      operator who is an anaesthesia Masters trainee, experienced in diagnostic abdominal
      ultrasound with more than 20 sonographic gastric volume assessments. The images will be
      recorded and validated by a consultant radiologist.

      Ultrasonographic views of antral area will be obtained using a curvilinear array 2- to 5-MHz
      transducer and a Mindray DC-70 (Shanghai, China) with image compounding technologies. Images
      will be obtained with the stomach at rest, and between peristaltic contractions. Sonograms of
      the antral area will be examined in 2 views, cross-section in the supine position, followed
      by the right lateral decubitus position, at each of the two scanning sessions.

      During ultrasonography, the antrum will be imaged in a parasagittal plane in the epigastric
      area using the left lobe of the liver, the inferior vena cava, and the superior mesenteric
      vein as internal landmarks. The two vessels are usually visualized slightly to the right of
      the abdominal midline. Once these vessels were identified, the transducer will be rotated
      slightly clockwise or counterclockwise to best obtain a true cross-sectional view of the
      antrum. The anteroposterior and craniocaudal diameters will be measured in this view.

      CSA of the antral area (a two-dimensional section) will be calculated according to the
      formula previously used by Bolondi18 using two maximum perpendicular diameters.

      This formula essentially represents the surface area of an ellipse, as follows: CSA (AP x CC
      x pie/4), where AP is the anteroposterior diameter and CC is the craniocaudal diameter
      measures in one decimal point.

      Estimation of gastric volume will be obtain using this formula:

      Predicted gastric volume based on right lateral CSA value : 27 + 14.6 * right lat CSA -
      1.28*age (negative volume value indicates and empty state).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Gastric volume assessment
time frame: 1 hour after intervention
description: Gastric volume can be calculated with gastric antrum measurement
measure: Gastric volume assessment
time frame: 2 hours after intervention
description: Gastric volume can be calculated with gastric antrum measurement
measure: Baseline gastric volume
time frame: Baseline
description: Baseline gastric volume assessed prior to ingestion of glucose loaded clear fluid
arm group label: 1 Hour post intervention
arm group type: Active Comparator
description: Ultrasound assessment done 1 hour after ingestion of glucose loaded drink
arm group label: 2 hours post intervention
arm group type: Placebo Comparator
description: Ultrasound assessment done 2 hour after ingestion of glucose loaded drink
intervention type: Other
intervention name: glucose loaded clear fluid
description: Ultrasound assessment of gastric antrum is done at different time interval following glucose loaded clear fluid ingestion
arm group label: 1 Hour post intervention
arm group label: 2 hours post intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Syarifah Noor Nazihah S Masri
role: Principal Investigator
affiliation: PPUKM
facility: 
country: Malaysia
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: Read MS, Vaughan RS. Allowing pre-operative patients to drink: effects on patients' safety and comfort of unlimited oral water until 2 hours before anaesthesia. Acta Anaesthesiol Scand. 1991 Oct;35(7):591-5. doi: 10.1111/j.1399-6576.1991.tb03354.x.
PMID: 1785235
citation: Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19.
PMID: 21596885
citation: Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
PMID: 29624530
responsible party type: Sponsor
sharing ipd: No
ipd description: IPD will be share on request