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

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

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.

Study Overview

• Status: Completed
• Conditions: Catheter Dysfunction
• Intervention / Treatment: Other: catheter dysfunction

• Study Type: Observational
• Enrollment (Actual): 381

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • CHRU de NANCY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric population

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pediatric population; pediatric population of CHU of Nancy, France.	Other: catheter dysfunction; prevalence of catheter dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Hervé Bouaziz, PH-D, CHU Nancy

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): February 2, 2021

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: pediatric; thrombotic; catheter infection; mechanical complication of catheter
• Other Study ID Numbers: 2021PI133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No