<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/NCT04477031</url>
  </required_header>
  <id_info>
    <org_study_id>RC17_0396</org_study_id>
    <nct_id>NCT04477031</nct_id>
  </id_info>
  <brief_title>Verification of the Safety of Normal Food Before a Cerebral Arteriography</brief_title>
  <acronym>VIANAC</acronym>
  <official_title>Verification of the Safety of Normal Food Before a Cerebral Arteriography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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>
      Fasting is currently required before elective cerebral angiography, despite numerous&#xD;
      arguments against fasting (kidney toxicity, vasovagal reaction, discomfort) and seams&#xD;
      unusefull regarding it's main goal : reducing nausea and vomiting. The investigators propose&#xD;
      to assess frequency of nausea and vomiting among patients having taken their breakfast at&#xD;
      home before day care angiography.&#xD;
&#xD;
      The investigators hypothesise that less than 1% of non fasting patients will suffer of&#xD;
      vomitint.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fasting is currently required before elective cerebral angiography, despite numerous&#xD;
      arguments against fasting (kidney toxicity, vasovagal reaction, discomfort) and seams&#xD;
      unusefull regarding it's main goal : reducing nausea and vomiting. The investigators propose&#xD;
      to assess frequency of nausea and vomiting among patients having taken their breakfast at&#xD;
      home before day care angiography.&#xD;
&#xD;
      The investigators hypothesise that less than 1% of non fasting patients will suffer of&#xD;
      vomitint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">June 15, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>frequency of vomiting during arteriographic procedure</measure>
    <time_frame>fifteen minutes</time_frame>
    <description>The investigators check if there is vomiting or not during the examination noted by an electro radiology manipulator. Safety issue : Bronchus inhalation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>nausea</measure>
    <time_frame>fifteen minutes</time_frame>
    <description>The nausea will be evaluated using an analog visual scale (EVA) by an electro-radiology manipulator (MAR)at the exit of the intervention room</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Cerebral Angiography</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients benefiting from a cerebral arteriography, within the UMCA of the North&#xD;
        Laënnec Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult,&#xD;
&#xD;
          -  non fasting,&#xD;
&#xD;
          -  day care hosptilalisation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Childs,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  parenteral nutrition,&#xD;
&#xD;
          -  nausea,&#xD;
&#xD;
          -  vomiting before arteriography,&#xD;
&#xD;
          -  arteriography under general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin Daumas-Duport, ph</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Nantes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benjamin Daumas-Duport, ph</last_name>
    <phone>02.40.16.56.11</phone>
    <email>benjamin.daumasduport@chu-nantes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Daumas-Duport</last_name>
      <phone>02.40.16.56.11</phone>
      <email>benjamin.daumasduport@chu-nantes.fr</email>
    </contact>
    <investigator>
      <last_name>Benjamin Daumas-Duport, PH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 10, 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>September 10, 2021</last_update_submitted>
  <last_update_submitted_qc>September 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fasting</keyword>
  <keyword>non fasting</keyword>
  <keyword>cerebral angiography</keyword>
  <keyword>nausea</keyword>
  <keyword>vomiting</keyword>
  <!-- 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/NCT04477031
org study id: RC17_0396
nct id: NCT04477031
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Fasting is currently required before elective cerebral angiography, despite numerous
      arguments against fasting (kidney toxicity, vasovagal reaction, discomfort) and seams
      unusefull regarding it's main goal : reducing nausea and vomiting. The investigators propose
      to assess frequency of nausea and vomiting among patients having taken their breakfast at
      home before day care angiography.

      The investigators hypothesise that less than 1% of non fasting patients will suffer of
      vomitint.
Fasting is currently required before elective cerebral angiography, despite numerous
      arguments against fasting (kidney toxicity, vasovagal reaction, discomfort) and seams
      unusefull regarding it's main goal : reducing nausea and vomiting. The investigators propose
      to assess frequency of nausea and vomiting among patients having taken their breakfast at
      home before day care angiography.

      The investigators hypothesise that less than 1% of non fasting patients will suffer of
      vomitint.
observational model: Other
time perspective: Prospective
measure: frequency of vomiting during arteriographic procedure
time frame: fifteen minutes
description: The investigators check if there is vomiting or not during the examination noted by an electro radiology manipulator. Safety issue : Bronchus inhalation
measure: nausea
time frame: fifteen minutes
description: The nausea will be evaluated using an analog visual scale (EVA) by an electro-radiology manipulator (MAR)at the exit of the intervention room
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Benjamin Daumas-Duport, ph
role: Principal Investigator
affiliation: CHU de Nantes
last name: Benjamin Daumas-Duport, ph
phone: 02.40.16.56.11
email: benjamin.daumasduport@chu-nantes.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor