<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/NCT02983175</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01501-50</org_study_id>
    <nct_id>NCT02983175</nct_id>
  </id_info>
  <brief_title>Ultrasound Assessment of Gastric Content Before Anesthesia for Appendectomy</brief_title>
  <acronym>EGASTA</acronym>
  <official_title>Ultrasound Assessment of Gastric Content and Gastric Volume Before Crash Induction for Appendectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of&#xD;
      gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during&#xD;
      anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol&#xD;
      qualified &quot;full stomach&quot; whatever the patient and the preoperative fasting period are. This&#xD;
      protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or&#xD;
      rocuronium). However, these neuromuscular blocking agents are ten times more at allergic risk&#xD;
      than others. Ultrasound assessment of gastric content before rapid sequence induction of&#xD;
      anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside&#xD;
      technique. Furthermore, the correlations between gastric volume and risk of a full stomach&#xD;
      and also between the cross-section antral area (CSA) and the risk of a full stomach have been&#xD;
      validated on several patient cohorts. We formulate the hypothesis that the achievement of a&#xD;
      gastric ultrasound before anesthetic induction for appendectomy could allow to identify &quot;full&#xD;
      stomach&quot; patients who actually justify rapid sequence induction of anesthesia with exposure&#xD;
      to fast-acting neuromuscular blocking agents that implies.&#xD;
&#xD;
      Primary endpoint is to determine te percentage of patients who have a gastric content before&#xD;
      appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and&#xD;
      anaphylactic shock. Another secondary endpoint is to determine the percentage of patient with&#xD;
      gastric content with the antral grading system (Perlas method) and to evaluate the&#xD;
      concordance between this methode and the cross-section antral area.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cross-section antral area (CSA)</measure>
    <time_frame>baseline J0</time_frame>
    <description>Ultrasonography exam of the stomach is used to evaluate the CSA. A CSA greater than 340mm² defines a full stomach. The calculation of the CSA is : CSA = AP x CC x π / 4 (in mm²). With AP - antero-posterior gastric antrum diameter and CC - cranio-caudal gastric antrum diameter</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Appendectomy</condition>
  <arm_group>
    <arm_group_label>ultrasound assessment of gastric content</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ultrasound assessment of gastric content</intervention_name>
    <description>Achievement of gastric ultrasound (specific procedure) :&#xD;
Gastric ultrasound is performed specifically for the study by a senior anesthetist physician in a patient placed supine, semi-sitting by an angle of 45 ° relative to the horizontal.&#xD;
Standardised achievement of the antral ultrasound by the following method:&#xD;
First, a qualitative assessment of antral contents in 3 grades according to the &quot;Perlas&quot; method [24].&#xD;
Second, performing a quantitative analysis of antral contents calculating the CSA.&#xD;
Then, volume of gastric contents calculation as from the CSA.</description>
    <arm_group_label>ultrasound assessment of gastric content</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient admitted to the operating room for appendectomy.&#xD;
&#xD;
          -  Major or minor patient (higher than 16) affiliated to a social security scheme.&#xD;
&#xD;
          -  Patient or parents of minor patient who received the full information relative to the&#xD;
             organization of the study and who signed his/their informed consent(s).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Childbearing age patient does not have effective contraception.&#xD;
&#xD;
          -  Breastfeeding woman.&#xD;
&#xD;
          -  Minor patient under 16.&#xD;
&#xD;
          -  Major patient subject to a measure of legal protection or unable to consent.&#xD;
&#xD;
          -  Persons deprived of liberty by a judicial or an administrative decision.&#xD;
&#xD;
          -  Patient with gastric and/or esophagus surgery history.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marie-Alix REGNIER-KIMMOUN, PH</last_name>
    <phone>03.83.85.14.03</phone>
    <phone_ext>+33</phone_ext>
    <email>ma.regnier@chru-nancy.fr</email>
  </overall_contact>
  <results_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>
  </results_reference>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Reddy JI, Cooke PJ, van Schalkwyk JM, Hannam JA, Fitzharris P, Mitchell SJ. Anaphylaxis is more common with rocuronium and succinylcholine than with atracurium. Anesthesiology. 2015 Jan;122(1):39-45. doi: 10.1097/ALN.0000000000000512.</citation>
    <PMID>25405395</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ultrasonogaphy</keyword>
  <keyword>full stomach</keyword>
  <keyword>pulmonary aspiration</keyword>
  <keyword>anaesthesia</keyword>
  <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/NCT02983175
org study id: 2016-A01501-50
nct id: NCT02983175
lead sponsor: 
has dmc: No
Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of
      gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during
      anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol
      qualified "full stomach" whatever the patient and the preoperative fasting period are. This
      protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or
      rocuronium). However, these neuromuscular blocking agents are ten times more at allergic risk
      than others. Ultrasound assessment of gastric content before rapid sequence induction of
      anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside
      technique. Furthermore, the correlations between gastric volume and risk of a full stomach
      and also between the cross-section antral area (CSA) and the risk of a full stomach have been
      validated on several patient cohorts. We formulate the hypothesis that the achievement of a
      gastric ultrasound before anesthetic induction for appendectomy could allow to identify "full
      stomach" patients who actually justify rapid sequence induction of anesthesia with exposure
      to fast-acting neuromuscular blocking agents that implies.

      Primary endpoint is to determine te percentage of patients who have a gastric content before
      appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and
      anaphylactic shock. Another secondary endpoint is to determine the percentage of patient with
      gastric content with the antral grading system (Perlas method) and to evaluate the
      concordance between this methode and the cross-section antral area.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Cross-section antral area (CSA)
time frame: baseline J0
description: Ultrasonography exam of the stomach is used to evaluate the CSA. A CSA greater than 340mm² defines a full stomach. The calculation of the CSA is : CSA = AP x CC x π / 4 (in mm²). With AP - antero-posterior gastric antrum diameter and CC - cranio-caudal gastric antrum diameter
arm group label: ultrasound assessment of gastric content
arm group type: Experimental
intervention type: Other
intervention name: ultrasound assessment of gastric content
description: Achievement of gastric ultrasound (specific procedure) :
Gastric ultrasound is performed specifically for the study by a senior anesthetist physician in a patient placed supine, semi-sitting by an angle of 45 ° relative to the horizontal.
Standardised achievement of the antral ultrasound by the following method:
First, a qualitative assessment of antral contents in 3 grades according to the "Perlas" method [24].
Second, performing a quantitative analysis of antral contents calculating the CSA.
Then, volume of gastric contents calculation as from the CSA.
arm group label: ultrasound assessment of gastric content
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Marie-Alix REGNIER-KIMMOUN, PH
phone: 03.83.85.14.03
phone ext: +33
email: ma.regnier@chru-nancy.fr
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: 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: Reddy JI, Cooke PJ, van Schalkwyk JM, Hannam JA, Fitzharris P, Mitchell SJ. Anaphylaxis is more common with rocuronium and succinylcholine than with atracurium. Anesthesiology. 2015 Jan;122(1):39-45. doi: 10.1097/ALN.0000000000000512.
PMID: 25405395
responsible party type: Sponsor
sharing ipd: No