Verification of the Safety of Normal Food Before a Cerebral Arteriography (VIANAC)

September 10, 2021 updated by: Nantes University Hospital

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 Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes
        • Contact:
        • Principal Investigator:
          • Benjamin Daumas-Duport, PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients benefiting from a cerebral arteriography, within the UMCA of the North Laënnec Hospital.

Description

Inclusion Criteria:

  • Adult,
  • non fasting,
  • day care hosptilalisation

Exclusion Criteria:

  • Childs,
  • pregnancy,
  • parenteral nutrition,
  • nausea,
  • vomiting before arteriography,
  • arteriography under general anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of vomiting during arteriographic procedure
Time Frame: fifteen minutes
The investigators check if there is vomiting or not during the examination noted by an electro radiology manipulator. Safety issue : Bronchus inhalation
fifteen minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nausea
Time Frame: 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
fifteen minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

December 15, 2024

Study Completion (Anticipated)

June 15, 2025

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC17_0396

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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