Verification of the Safety of Normal Food Before a Cerebral Arteriography

Cerebral Angiography Clinical Trial

— VIANAC  

Official title:

Verification of the Safety of Normal Food Before a Cerebral Arteriography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04477031
• Other study ID #: RC17_0396
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: June 15, 2025

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: Benjamin Daumas-Duport, ph
• Phone: 02.40.16.56.11
• Email: benjamin.daumasduport[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adult,

• non fasting,

• day care hosptilalisation

Exclusion Criteria:

• Childs,

• pregnancy,

• parenteral nutrition,

• nausea,

• vomiting before arteriography,

• arteriography under general anesthesia

Related Conditions & MeSH terms

• Cerebral Angiography

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of vomiting during arteriographic procedure	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	nausea	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