Catheter Dysfunction Clinical Trial
Official title:
Long-term Venous Catheterization in Pediatric Anesthesia: Prevalence and Risk Factors of Dysfunction.
| 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 |
| Verified date | August 2021 |
| Source | Central Hospital, Nancy, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU de Nancy | Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Central Hospital, Nancy, France |
France,
| 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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