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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05005598
Other study ID # 2021PI133
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date February 2, 2021

Study information

Verified date August 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 381
Est. completion date February 2, 2021
Est. primary completion date January 1, 2018
Accepts healthy volunteers
Gender All
Age group N/A to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
catheter dysfunction
prevalence of catheter dysfunction

Locations

Country Name City State
France CHRU de Nancy Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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