Long-term Venous Catheterization in Pediatric Anesthesia:... | NCT05005598

Studies
Long-term Venous Catheterization in Pediatric Anesthesia: Prevalence and Risk Factors of Dysfunction

NCT05005598

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Aug 18, 2021Actual

Enrollment

381Actual

Phase

Not provided

Conditions

Catheter Dysfunction

Interventions

catheter dysfunction

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

Aug 2021

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

Jan 1, 2018Actual

Primary Completion Date

Jan 1, 2018Actual

Completion Date

Feb 2, 2021Actual

First Submitted Date

Aug 10, 2021

First Submission Date that Met QC Criteria

Aug 12, 2021

First Posted Date

Aug 13, 2021Actual

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

Aug 12, 2021

Last Update Posted Date

Aug 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

BOUAZIZ Hervé, Clinical Professor, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

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

To evaluate the prevalence of long-life catheters dysfunction and identify the risk factors associated to premature withdrawal in pediatric population.

For that: retrospective study, during 3 years, in CHU Nancy. Data collection by informatics file after patient agreement. Primary objective: mesure prevalence of long-life catheter dysfunction

Secondary objectives:

identify risk factors associated to premature withdrawals by thrombotic, infectious, accidental, mechanical complications.
mesure de time spent by anethesist to put long-life catheters in emergency. Benefit of creating à vascular access unit.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

381Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pediatric population		pediatric population of CHU of Nancy, France.	Other: catheter dysfunction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
catheter dysfunction	Other	prevalence of catheter dysfunction	pediatric population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevalence of premature withdrawals of long-term vascular device	the pourcentage of premature withdrawals of these catheters	Baseline (J0) is the day when the catheter is placed, up to 1 year

Secondary Outcomes

Measure	Description	Time Frame
identify risk factors associated to premature withdrawal long-life catheter	descriptive disfunction of catheter in the medical file	Baseline (J0) is the day when the catheter is placed, up to 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

long-life catheter (midline, piccline, central venous catheter)
placed in operating room
by anesthesist
in pédiatric population: 0 to 18 years

Exclusion Criteria:

more than 18 years
peripheral venous access
not placed by anesthesist
placed outside operating room

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pediatric population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hervé Bouaziz, PH-D	Central Hospital, Nancy, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Nancy		Nancy		54000	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided