<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/NCT03036774</url>
  </required_header>
  <id_info>
    <org_study_id>2014/30</org_study_id>
    <secondary_id>2015-A01997-47</secondary_id>
    <nct_id>NCT03036774</nct_id>
  </id_info>
  <brief_title>Ultrasound Measure of Gastric Volume in Diabetic and Non Diabetic Patients Before General Anesthesia</brief_title>
  <acronym>ECHODIABETE</acronym>
  <official_title>Quantitative Ultrasound Assessment of Gastric Volume in Diabetic and Non Diabetic Patients Scheduled for a General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</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>
      The main objective is to compare the frequency of a &quot; full stomach &quot; in diabetic patients&#xD;
      compared with a control population, all the patients having followed the instructions of&#xD;
      preoperative fast.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2017</start_date>
  <completion_date type="Actual">February 6, 2019</completion_date>
  <primary_completion_date type="Actual">February 6, 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>Other</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with full stomach</measure>
    <time_frame>one day</time_frame>
    <description>The main objective is to compare the frequency of a &quot;full stomach&quot; in the diabetic population compared to a &quot;control&quot; population just before induction of general anesthesia.&#xD;
A &quot;full stomach&quot; is defined by an antral area &gt; 340 mm2&#xD;
The main objective is to compare the frequency of a &quot;full stomach&quot; in the diabetic population compared to a &quot;control&quot; population just before induction of general anesthesia.&#xD;
A &quot;full stomach&quot; is defined by an antral area &gt; 340 mm2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemia</measure>
    <time_frame>one day</time_frame>
    <description>To assess the relationship between preoperative blood glucose and gastric emptying in the diabetic population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fast duration</measure>
    <time_frame>one day</time_frame>
    <description>To compare the impact of the duration of fasting on the gastric residue in both populations of patients (diabetic and non-diabetic)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycated hemoglobin</measure>
    <time_frame>one day</time_frame>
    <description>To assess the relationship between glycated hemoglobin and gastric emptying in the diabetic population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of anxiety using a numerical scale (from 0 -no anxiety- to 10 -maximal anxiety-)</measure>
    <time_frame>one day</time_frame>
    <description>To compare the impact of anxiety on the gastric residue in both populations of patients (diabetic and non-diabetic) in both populations of patients (diabetic and non-diabetic)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of anxiety using a numerical scale (from 0 -no pain- to 10 -maximal pain-)</measure>
    <time_frame>one day</time_frame>
    <description>To compare the impact of pain on the gastric residue in both populations of patients (diabetic and non-diabetic) in both populations of patients (diabetic and non-diabetic)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative hypoxemia</measure>
    <time_frame>one day</time_frame>
    <description>Evaluation of the risk of intraoperative pulmonary inhalation in both populations of patients (diabetic and non-diabetic)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">245</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Diabetic patient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diabetic patients (type 1 or type 2 diabetes) with scheduled surgery . Ultrasonic measurement of antral area</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non diabetic patient</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with scheduled surgery without history of diabetes or a current, treated or untreated, diabetic disease.&#xD;
Ultrasonic measurement of antral area</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasonic measurement of antral area</intervention_name>
    <description>Antral area is measured by ultrasound using a curvilinear abdominal probe of 2-5 MHz and a Logiq E (General Electrics) type echograph or equivalent.&#xD;
Ultrasound is done before the induction of general anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed.&#xD;
Antral area (CSA expressed in mm²) is show by the following formula: CSA = AP × CC × π / 4.&#xD;
Antral area will correspond to the average of the three measures.</description>
    <arm_group_label>Diabetic patient</arm_group_label>
    <arm_group_label>Non diabetic patient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged over 18&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) classification 1 to 3&#xD;
&#xD;
          -  Needed a general anesthesia for a programmed surgical intervention&#xD;
&#xD;
          -  Respect of instructions of the pre-operative fasting;&#xD;
&#xD;
          -  Affiliation to the social security;&#xD;
&#xD;
          -  Consent form signed&#xD;
&#xD;
        Non inclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Patients already operated or to be operated from the upper digestive tract (esophagus,&#xD;
             stomach, duodenum)&#xD;
&#xD;
          -  Patients treated with a prokinetic treatment and / or a level 3 analgesic&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Unfeasibility to ultrasound measurement of antral area&#xD;
&#xD;
          -  Failure to observe fasting instructions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julien Rousset, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Tenon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marc Fischler, MD-PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hôpital Foch</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francis Bonnet, MD-PhD</last_name>
    <role>Study Chair</role>
    <affiliation>HopitalTenon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondation Ophtalmologique Adolphe de Rotschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP Hopital Tenon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric contents</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Diabetes</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/NCT03036774
org study id: 2014/30
secondary id: 2015-A01997-47
nct id: NCT03036774
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective is to compare the frequency of a " full stomach " in diabetic patients
      compared with a control population, all the patients having followed the instructions of
      preoperative fast.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Care Provider)
measure: Number of patients with full stomach
time frame: one day
description: The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a "control" population just before induction of general anesthesia.
A "full stomach" is defined by an antral area > 340 mm2
The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a "control" population just before induction of general anesthesia.
A "full stomach" is defined by an antral area > 340 mm2
measure: Glycemia
time frame: one day
description: To assess the relationship between preoperative blood glucose and gastric emptying in the diabetic population
measure: Fast duration
time frame: one day
description: To compare the impact of the duration of fasting on the gastric residue in both populations of patients (diabetic and non-diabetic)
measure: Glycated hemoglobin
time frame: one day
description: To assess the relationship between glycated hemoglobin and gastric emptying in the diabetic population
measure: Evaluation of anxiety using a numerical scale (from 0 -no anxiety- to 10 -maximal anxiety-)
time frame: one day
description: To compare the impact of anxiety on the gastric residue in both populations of patients (diabetic and non-diabetic) in both populations of patients (diabetic and non-diabetic)
measure: Evaluation of anxiety using a numerical scale (from 0 -no pain- to 10 -maximal pain-)
time frame: one day
description: To compare the impact of pain on the gastric residue in both populations of patients (diabetic and non-diabetic) in both populations of patients (diabetic and non-diabetic)
measure: Intraoperative hypoxemia
time frame: one day
description: Evaluation of the risk of intraoperative pulmonary inhalation in both populations of patients (diabetic and non-diabetic)
arm group label: Diabetic patient
arm group type: Experimental
description: Diabetic patients (type 1 or type 2 diabetes) with scheduled surgery . Ultrasonic measurement of antral area
arm group label: Non diabetic patient
arm group type: Other
description: Patients with scheduled surgery without history of diabetes or a current, treated or untreated, diabetic disease.
Ultrasonic measurement of antral area
intervention type: Procedure
intervention name: Ultrasonic measurement of antral area
description: Antral area is measured by ultrasound using a curvilinear abdominal probe of 2-5 MHz and a Logiq E (General Electrics) type echograph or equivalent.
Ultrasound is done before the induction of general anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed.
Antral area (CSA expressed in mm²) is show by the following formula: CSA = AP × CC × π / 4.
Antral area will correspond to the average of the three measures.
arm group label: Diabetic patient
arm group label: Non diabetic patient
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julien Rousset, MD
role: Principal Investigator
affiliation: Hôpital Tenon
last name: Marc Fischler, MD-PhD
role: Study Chair
affiliation: Hôpital Foch
last name: Francis Bonnet, MD-PhD
role: Study Chair
affiliation: HopitalTenon
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No