<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/NCT04501393</url>
  </required_header>
  <id_info>
    <org_study_id>382/2563</org_study_id>
    <nct_id>NCT04501393</nct_id>
  </id_info>
  <brief_title>Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients</brief_title>
  <official_title>Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</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>
      Research in developing patient fasting guidelines was developed years ago. On a physiological&#xD;
      basis, patients with a longer fasting time may have less residual gastric content and lower&#xD;
      risk of pulmonary aspiration. The recent Practice Guidelines for Preoperative Fasting and the&#xD;
      Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration of The American&#xD;
      Society of Anesthesiologists (ASA) was published in March 2017. Current practice consists of&#xD;
      2-hour fasting period for clear oral fluid (including water, pulp-free juice and tea or&#xD;
      coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for&#xD;
      non-human milk and solid food. However, there are only few supportive and suggestive&#xD;
      scientific evidences. The purpose of this study is to evaluate the current clinical practice&#xD;
      guidelines for preoperative fasting to enhance the quality of pediatric anesthesia care and&#xD;
      promote patient safety.The investigators plan to enroll adults aged 18-60 years, who are&#xD;
      scheduled for esophago-gastro-duodenoscopy (EGD), in order to study the effects of fasting&#xD;
      time and the actual intragastric volume which may help us establish a comprehensive fasting&#xD;
      guideline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research in developing patient NPO guidelines was developed years ago. On a physiological&#xD;
      basis, patients with a longer fasting time may have less residual gastric content and lower&#xD;
      risk of pulmonary aspiration. The recent Practice Guidelines for Preoperative Fasting and the&#xD;
      Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration of The American&#xD;
      Society of Anesthesiologists (ASA) was published in March 2017. Current practice consists of&#xD;
      2-hour fasting period for clear oral fluid (including water, pulp-free juice and tea or&#xD;
      coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for&#xD;
      non-human milk and solid food. However, there are only few supportive (category A) and&#xD;
      suggestive (category B) scientific evidences.&#xD;
&#xD;
      Since Maltby et al showed results of patient's safety in elective surgical patients who had&#xD;
      clear oral fluid intake 2 hours before surgery in 1986, the published clinical evidence is&#xD;
      still insufficient to address the relationship between pulmonary aspiration and fasting time&#xD;
      . For breast milk, infant formula and solid food, the latest Practice Guidelines for&#xD;
      Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary&#xD;
      Aspiration in 2011 also follow previous suggestion of fasting time because of inadequate&#xD;
      updated supportive clinical trials.&#xD;
&#xD;
      The purpose of this study is to evaluate the current clinical practice guidelines for&#xD;
      preoperative fasting to enhance the quality of pediatric anesthesia care and promote patient&#xD;
      safety. Andersson et al. reviewed 10,015 pediatric anesthesia charts retrospectively and&#xD;
      found an incidence of 3 cases of pulmonary aspiration in 10,000 pediatric anesthesia patients&#xD;
      who were allowed to drink clear liquid fluids until called to operative rooms . This approach&#xD;
      promotes patient safety by minimizing a patient's dehydration status and reduced&#xD;
      intraoperative hypotensive events. Furthermore, shortened fasting times also decreases&#xD;
      patient irritability and improves parental satisfaction in preoperative experiences.&#xD;
&#xD;
      The investigators plan to enroll adults ages 18-60 years old, who are scheduled for&#xD;
      esophago-gastro-duodenoscopy (EGD) at Siriraj hospital. This observational study will be&#xD;
      conducted in 2 stages; (1) preoperative period (2) intraoperative period. Patients'&#xD;
      demographic information will be collected along with NPO history including times, volume and&#xD;
      type of fluid/ food intake in the preoperative period. Intragastric volume and pH from each&#xD;
      patient's stomach at the beginning of EGD procedure will be measured in the intraoperative&#xD;
      period.&#xD;
&#xD;
      The investigators believe that the information from this study will help us understand the&#xD;
      effects of NPO time and the actual intragastric volume which may help establish a&#xD;
      comprehensive NPO guideline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Residual gastric volume</measure>
    <time_frame>at 2 hour after drinking, during endoscopic procedure</time_frame>
    <description>Collect actual intra-gastric content volume after drinking assigned amount of fluid at 2-hour fasting period of each patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastric acidity (pH)</measure>
    <time_frame>at 2 hour after drinking, during endoscopic procedure</time_frame>
    <description>Collect actual intra-gastric content pH after drinking assigned amount of fluid at 2-hour fasting period of each patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypotension</measure>
    <time_frame>at 2 hour after drinking, during endoscopic procedure</time_frame>
    <description>Compare hypotension incidence of each group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative nausea and vomitting</measure>
    <time_frame>pre-endoscopic procedure</time_frame>
    <description>Compare postoperative nausea and vomiting incidence of each group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ready to discharge time</measure>
    <time_frame>When the procedure finish until ready to discharge, approximately 1-2 hours after endoscopy</time_frame>
    <description>Compare ready to discharge time of each group</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Fasting</condition>
  <arm_group>
    <arm_group_label>0 ml/kg</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants will not be asked to drink anything at 2 hours prior to planned procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 ml/kg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants will be asked to drink 3ml/kg of clear liquid at 2 hours prior to planned procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>7 ml/kg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants will be asked to drink 7 ml/kg of clear liquid at 2 hours prior to planned procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 ml/kg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants will be asked to drink 10 ml/kg of clear liquid at 2 hours prior to planned procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clear liquid intake</intervention_name>
    <description>Clear oral fluid including water, pulp-free juice and tea or coffee without milk</description>
    <arm_group_label>10 ml/kg</arm_group_label>
    <arm_group_label>3 ml/kg</arm_group_label>
    <arm_group_label>7 ml/kg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are 18-60 years scheduled for EGD procedure&#xD;
&#xD;
          -  Patient who willing to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who scheduled for emergent EGD procedures&#xD;
&#xD;
          -  Patients with active upper GI bleeding&#xD;
&#xD;
          -  Patients who received preoperative oral medication&#xD;
&#xD;
          -  BMI &gt; 30 kg/m2&#xD;
&#xD;
          -  Patients with previous GI motility or acid-base pathology&#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_contact>
    <last_name>Sirirat Rattanaarpa, MD</last_name>
    <phone>024197989</phone>
    <email>rattanaarpa.s@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patcharee Sriswasdi, MD, MPH</last_name>
    <phone>024197989</phone>
    <email>pat.si.research@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Medicine, Siriraj hospital</name>
      <address>
        <city>Bangkok Noi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sirirat Rattana-arpa, MD</last_name>
      <phone>+66819099242</phone>
      <email>mednoonr@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>March 19, 2023</last_update_submitted>
  <last_update_submitted_qc>March 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04501393
org study id: 382/2563
nct id: NCT04501393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Research in developing patient fasting guidelines was developed years ago. On a physiological
      basis, patients with a longer fasting time may have less residual gastric content and lower
      risk of pulmonary aspiration. The recent Practice Guidelines for Preoperative Fasting and the
      Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration of The American
      Society of Anesthesiologists (ASA) was published in March 2017. Current practice consists of
      2-hour fasting period for clear oral fluid (including water, pulp-free juice and tea or
      coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for
      non-human milk and solid food. However, there are only few supportive and suggestive
      scientific evidences. The purpose of this study is to evaluate the current clinical practice
      guidelines for preoperative fasting to enhance the quality of pediatric anesthesia care and
      promote patient safety.The investigators plan to enroll adults aged 18-60 years, who are
      scheduled for esophago-gastro-duodenoscopy (EGD), in order to study the effects of fasting
      time and the actual intragastric volume which may help us establish a comprehensive fasting
      guideline.
Research in developing patient NPO guidelines was developed years ago. On a physiological
      basis, patients with a longer fasting time may have less residual gastric content and lower
      risk of pulmonary aspiration. The recent Practice Guidelines for Preoperative Fasting and the
      Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration of The American
      Society of Anesthesiologists (ASA) was published in March 2017. Current practice consists of
      2-hour fasting period for clear oral fluid (including water, pulp-free juice and tea or
      coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for
      non-human milk and solid food. However, there are only few supportive (category A) and
      suggestive (category B) scientific evidences.

      Since Maltby et al showed results of patient's safety in elective surgical patients who had
      clear oral fluid intake 2 hours before surgery in 1986, the published clinical evidence is
      still insufficient to address the relationship between pulmonary aspiration and fasting time
      . For breast milk, infant formula and solid food, the latest Practice Guidelines for
      Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary
      Aspiration in 2011 also follow previous suggestion of fasting time because of inadequate
      updated supportive clinical trials.

      The purpose of this study is to evaluate the current clinical practice guidelines for
      preoperative fasting to enhance the quality of pediatric anesthesia care and promote patient
      safety. Andersson et al. reviewed 10,015 pediatric anesthesia charts retrospectively and
      found an incidence of 3 cases of pulmonary aspiration in 10,000 pediatric anesthesia patients
      who were allowed to drink clear liquid fluids until called to operative rooms . This approach
      promotes patient safety by minimizing a patient's dehydration status and reduced
      intraoperative hypotensive events. Furthermore, shortened fasting times also decreases
      patient irritability and improves parental satisfaction in preoperative experiences.

      The investigators plan to enroll adults ages 18-60 years old, who are scheduled for
      esophago-gastro-duodenoscopy (EGD) at Siriraj hospital. This observational study will be
      conducted in 2 stages; (1) preoperative period (2) intraoperative period. Patients'
      demographic information will be collected along with NPO history including times, volume and
      type of fluid/ food intake in the preoperative period. Intragastric volume and pH from each
      patient's stomach at the beginning of EGD procedure will be measured in the intraoperative
      period.

      The investigators believe that the information from this study will help us understand the
      effects of NPO time and the actual intragastric volume which may help establish a
      comprehensive NPO guideline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Residual gastric volume
time frame: at 2 hour after drinking, during endoscopic procedure
description: Collect actual intra-gastric content volume after drinking assigned amount of fluid at 2-hour fasting period of each patient.
measure: Gastric acidity (pH)
time frame: at 2 hour after drinking, during endoscopic procedure
description: Collect actual intra-gastric content pH after drinking assigned amount of fluid at 2-hour fasting period of each patient.
measure: Hypotension
time frame: at 2 hour after drinking, during endoscopic procedure
description: Compare hypotension incidence of each group
measure: Post operative nausea and vomitting
time frame: pre-endoscopic procedure
description: Compare postoperative nausea and vomiting incidence of each group
measure: Ready to discharge time
time frame: When the procedure finish until ready to discharge, approximately 1-2 hours after endoscopy
description: Compare ready to discharge time of each group
arm group label: 0 ml/kg
arm group type: No Intervention
description: The participants will not be asked to drink anything at 2 hours prior to planned procedure.
arm group label: 3 ml/kg
arm group type: Active Comparator
description: The participants will be asked to drink 3ml/kg of clear liquid at 2 hours prior to planned procedure.
arm group label: 7 ml/kg
arm group type: Active Comparator
description: The participants will be asked to drink 7 ml/kg of clear liquid at 2 hours prior to planned procedure.
arm group label: 10 ml/kg
arm group type: Active Comparator
description: The participants will be asked to drink 10 ml/kg of clear liquid at 2 hours prior to planned procedure.
intervention type: Other
intervention name: Clear liquid intake
description: Clear oral fluid including water, pulp-free juice and tea or coffee without milk
arm group label: 10 ml/kg
arm group label: 3 ml/kg
arm group label: 7 ml/kg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sirirat Rattanaarpa, MD
phone: 024197989
email: rattanaarpa.s@gmail.com
last name: Patcharee Sriswasdi, MD, MPH
phone: 024197989
email: pat.si.research@gmail.com
facility: 
status: Recruiting
contact: 
country: Thailand
responsible party type: Sponsor
sharing ipd: No