NCT05005598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
381

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

Same day

First QC Date

August 10, 2021

Last Update Submit

August 12, 2021

Conditions

Catheter Dysfunction

Keywords

pediatricthromboticcatheter infectionmechanical complication of catheter

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • identify risk factors associated to premature withdrawal long-life catheter

    Baseline (J0) is the day when the catheter is placed, up to 1 year

Study Arms (1)

pediatric population

pediatric population of CHU of Nancy, France.

Other: catheter dysfunction

Interventions

catheter dysfunctionOTHER

prevalence of catheter dysfunction

pediatric population

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric population

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Nancy, 54000, France

Location

Study Officials

  • Hervé Bouaziz, PH-D

    CHU NANCY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 13, 2021

Study Start

January 1, 2018

Primary Completion

January 1, 2018

Study Completion

February 2, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Locations

FR(1)