<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/NCT04413474</url>
  </required_header>
  <id_info>
    <org_study_id>2017/72</org_study_id>
    <nct_id>NCT04413474</nct_id>
  </id_info>
  <brief_title>Ultrasonographic Assessment of Gastric Residual Volume</brief_title>
  <official_title>Does Ultrasonographic Assessment of Gastric Antrum Correlate With Gastric Residual Volume in Critically Ill Patients? A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gurhan Taskin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gulhane School of Medicine</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>
      A recent systematic review reported that the prevalence of enteral nutrition intolerance in&#xD;
      critically ill patients ranged from 2% to 75%, and the pooled rate was 38.3%.Many randomized&#xD;
      controlled trials have reported that the incidence of pneumonia, regurgitation and aspiration&#xD;
      do not correlate well with gastric residual volume (GRV) monitoring. In addition, it was&#xD;
      reported that GRV monitoring may cause more frequent obstructions in the enteral tube access,&#xD;
      leading to greater loss of time for intensive care unit nurses and patients receiving less&#xD;
      than the prescribed daily intake due to enteral nutrition interruptions. The most recent&#xD;
      SCCM/ASPEN guidelines in 2016 recommended that GRV monitoring not be included in the daily&#xD;
      care protocol, but many institutions still use it to determine whether to continue enteral&#xD;
      nutrition or to detect enteral tube-feeding intolerance. This study aimed to evaluate the&#xD;
      relationship between ultrasonographic gastric antral measurements and aspirated gastric&#xD;
      residual volume GRV in mechanically ventilated critically ill patients receiving enteral tube&#xD;
      feeding via nasogastric, orogastric, or percutaneous gastrostomy tubes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data collection and measurements:&#xD;
&#xD;
      The following clinical parameters of included patients will be recorded: age, sex, body&#xD;
      weight, height, body mass index, Acute Physiology and Chronic Health Evaluation II (APACHE&#xD;
      II) score on the day of admission,the Charlson Comorbidity Index score, any comorbid&#xD;
      diseases, the total amount of EN product during the last 24 hours before ultrasonographic&#xD;
      assessment, vasopressor therapy during imaging, and the dose of the vasopressors.&#xD;
&#xD;
      Ultrasonographic gastric antrum imaging procedure:&#xD;
&#xD;
      Ultrasonographic gastric antrum imaging will be carried out by the same intensivist on each&#xD;
      patient just before routine tube-feed aspiration. Gastric antrum images will be obtained with&#xD;
      a 2.5-6 MHz curvilinear probe placed in the sagittal plane of the epigastric region. All&#xD;
      imaging attempts will be carried out in a 30-degree head-elevation supine position as&#xD;
      described previously. Reference points will be used to obtain images of the gastric&#xD;
      antrum-left anterior lobe of the liver, head of pancreas and abdominal aorta.The&#xD;
      anteroposterior and craniocaudal diameters of the gastric antrum will be measured three times&#xD;
      for each ultrasonographic assessment. The mean value of the three will be recorded. The&#xD;
      universally accepted Two-Diameter Method defined by Bolondi et al. will be used for the&#xD;
      measurement of antral cross-sectional area.&#xD;
&#xD;
      Tube-feeding aspiration (GRV measurement) procedure:&#xD;
&#xD;
      Routine gastric residual volume aspirations will be performed by the nursing staff blinded to&#xD;
      the ultrasonographic measurements. The time between gastric antrum imaging and the beginning&#xD;
      of GRV aspiration will be recorded in minutes. Gastric contents will slowly aspirated with 50&#xD;
      ml syringes for at least 10 minutes until stomach contents could no longer be aspirated.&#xD;
      Patients will be reassessed with ultrasonography after the aspiration to ensure that the&#xD;
      stomach is completely emptied with aspiration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">January 19, 2019</completion_date>
  <primary_completion_date type="Actual">January 19, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Correlation between antral cross-sectional area and enteral tube feeding volumes.</measure>
    <time_frame>From date of inclusion until the date of enteral tube-feeding termination or until the date of weaning from mechanical ventilation or until the date of discharging from ICU or until the date of the death, whichever came first, assessed up to one month.</time_frame>
    <description>The correlation between aspirated tube-feeding volumes and ultrasonographic gastric antral cross-sectional area measurements in critically ill patients receiving enteral tube feeding.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">56</enrollment>
  <condition>Critically Ill</condition>
  <condition>Enteral Feeding Intolerance</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <description>Unselected critically ill patients who met the inclusion criteria</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Mechanically ventilated critically ill patients receiving enteral feeding via nasogastric,&#xD;
        orogastric, or percutaneous gastrostomy tubes who admitted to ICU in a one year period&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Mechanically ventilated in the intensive care unit&#xD;
&#xD;
          -  Receiving enteral tube feeding via nasogastric, orogastric, or percutaneous&#xD;
             gastrostomy tubes, and the tip of the enteral feeding-tube having been shown to be&#xD;
             present in the stomach in a recent x-ray&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Intestinal obstruction, gastric perforation, known upper gastrointestinal anatomical&#xD;
             problem (e.g., hiatal hernia, gastric cancer, etc.)&#xD;
&#xD;
          -  Food and liquid by mouth being withheld due to long-term fasting requirement for any&#xD;
             medical reasons (e.g., gastrointestinal tract bleeding, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gurhan Taskin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gulhane School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Health Sciences, Trabzon Kanuni Training and Research Hospital</name>
      <address>
        <city>Trabzon</city>
        <zip>61250</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Gulhane School of Medicine</investigator_affiliation>
    <investigator_full_name>Gurhan Taskin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>critical care</keyword>
  <keyword>ultrasonography</keyword>
  <keyword>enteral feeding</keyword>
  <keyword>enteral nutrition</keyword>
  <keyword>feeding intolerance</keyword>
  <keyword>gastric volume</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All individual patient data that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Starting 6 months after publication</ipd_time_frame>
    <ipd_access_criteria>If requested the individual patient data will be shared.</ipd_access_criteria>
  </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/NCT04413474
org study id: 2017/72
nct id: NCT04413474
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A recent systematic review reported that the prevalence of enteral nutrition intolerance in
      critically ill patients ranged from 2% to 75%, and the pooled rate was 38.3%.Many randomized
      controlled trials have reported that the incidence of pneumonia, regurgitation and aspiration
      do not correlate well with gastric residual volume (GRV) monitoring. In addition, it was
      reported that GRV monitoring may cause more frequent obstructions in the enteral tube access,
      leading to greater loss of time for intensive care unit nurses and patients receiving less
      than the prescribed daily intake due to enteral nutrition interruptions. The most recent
      SCCM/ASPEN guidelines in 2016 recommended that GRV monitoring not be included in the daily
      care protocol, but many institutions still use it to determine whether to continue enteral
      nutrition or to detect enteral tube-feeding intolerance. This study aimed to evaluate the
      relationship between ultrasonographic gastric antral measurements and aspirated gastric
      residual volume GRV in mechanically ventilated critically ill patients receiving enteral tube
      feeding via nasogastric, orogastric, or percutaneous gastrostomy tubes.
Data collection and measurements:

      The following clinical parameters of included patients will be recorded: age, sex, body
      weight, height, body mass index, Acute Physiology and Chronic Health Evaluation II (APACHE
      II) score on the day of admission,the Charlson Comorbidity Index score, any comorbid
      diseases, the total amount of EN product during the last 24 hours before ultrasonographic
      assessment, vasopressor therapy during imaging, and the dose of the vasopressors.

      Ultrasonographic gastric antrum imaging procedure:

      Ultrasonographic gastric antrum imaging will be carried out by the same intensivist on each
      patient just before routine tube-feed aspiration. Gastric antrum images will be obtained with
      a 2.5-6 MHz curvilinear probe placed in the sagittal plane of the epigastric region. All
      imaging attempts will be carried out in a 30-degree head-elevation supine position as
      described previously. Reference points will be used to obtain images of the gastric
      antrum-left anterior lobe of the liver, head of pancreas and abdominal aorta.The
      anteroposterior and craniocaudal diameters of the gastric antrum will be measured three times
      for each ultrasonographic assessment. The mean value of the three will be recorded. The
      universally accepted Two-Diameter Method defined by Bolondi et al. will be used for the
      measurement of antral cross-sectional area.

      Tube-feeding aspiration (GRV measurement) procedure:

      Routine gastric residual volume aspirations will be performed by the nursing staff blinded to
      the ultrasonographic measurements. The time between gastric antrum imaging and the beginning
      of GRV aspiration will be recorded in minutes. Gastric contents will slowly aspirated with 50
      ml syringes for at least 10 minutes until stomach contents could no longer be aspirated.
      Patients will be reassessed with ultrasonography after the aspiration to ensure that the
      stomach is completely emptied with aspiration.
observational model: Cohort
time perspective: Prospective
measure: Correlation between antral cross-sectional area and enteral tube feeding volumes.
time frame: From date of inclusion until the date of enteral tube-feeding termination or until the date of weaning from mechanical ventilation or until the date of discharging from ICU or until the date of the death, whichever came first, assessed up to one month.
description: The correlation between aspirated tube-feeding volumes and ultrasonographic gastric antral cross-sectional area measurements in critically ill patients receiving enteral tube feeding.
arm group label: Study group
description: Unselected critically ill patients who met the inclusion criteria
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Gurhan Taskin, MD
role: Principal Investigator
affiliation: Gulhane School of Medicine
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Gulhane School of Medicine
investigator full name: Gurhan Taskin
investigator title: Principal Investigator
mesh term: Critical Illness
sharing ipd: Yes
ipd description: All individual patient data that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Starting 6 months after publication
ipd access criteria: If requested the individual patient data will be shared.