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VIANAC: Verification of the Safety of Normal Food Before a Cerebral Arteriography

Sponsor
Nantes University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04477031
Collaborator
(none)
1,000
Enrollment
1
Location
54.4
Anticipated Duration (Months)
18.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Verification of the Safety of Normal Food Before a Cerebral Arteriography
    Actual Study Start Date :
    Dec 1, 2020
    Anticipated Primary Completion Date :
    Dec 15, 2024
    Anticipated Study Completion Date :
    Jun 15, 2025

    Outcome Measures

    Primary Outcome Measures

    1. frequency of vomiting during arteriographic procedure [fifteen minutes]

      The investigators check if there is vomiting or not during the examination noted by an electro radiology manipulator. Safety issue : Bronchus inhalation

    Secondary Outcome Measures

    1. nausea [fifteen minutes]

      The nausea will be evaluated using an analog visual scale (EVA) by an electro-radiology manipulator (MAR)at the exit of the intervention room

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult,

    • non fasting,

    • day care hosptilalisation

    Exclusion Criteria:

    • Childs,

    • pregnancy,

    • parenteral nutrition,

    • nausea,

    • vomiting before arteriography,

    • arteriography under general anesthesia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Nantes Nantes France 44093

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    • Principal Investigator: Benjamin Daumas-Duport, ph, CHU de Nantes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nantes University Hospital
    ClinicalTrials.gov Identifier:
    NCT04477031
    Other Study ID Numbers:
    • RC17_0396
    First Posted:
    Jul 20, 2020
    Last Update Posted:
    Sep 13, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nantes University Hospital
    Fasting
    non fasting
    cerebral angiography
    nausea
    vomiting

    Study Results

    No Results Posted as of Sep 13, 2021