Verification of the Safety of Normal Food Before a Cerebr... | NCT04477031

Studies
Verification of the Safety of Normal Food Before a Cerebral Arteriography

NCT04477031

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Jul 17, 2025Actual

Enrollment

677Actual

Phase

Not provided

Conditions

Cerebral Angiography

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Dec 1, 2024Actual

Completion Date

Dec 1, 2024Actual

First Submitted Date

Jul 10, 2020

First Submission Date that Met QC Criteria

Jul 15, 2020

First Posted Date

Jul 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2025

Last Update Posted Date

Jul 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The investigators hypothesise that less than 1% of non fasting patients will suffer of vomitint.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

677Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult,
non fasting,
day care hosptilalisation

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin Daumas-Duport, ph	Nantes University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nantes		Nantes		44093	France

Condition Browse Module

MeSH Terms

ID	Term
D005215	Fasting
D009325	Nausea
D014839	Vomiting

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided