Catheter DysfunctionNCT05005598
Long-term Venous Catheterization in Pediatric Anesthesia: Prevalence and Risk Factors of Dysfunction
An observational study of Catheter Dysfunction, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Catheter Dysfunction
- What is being tested?
- catheter dysfunction
- How many people
- 381 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 2 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: Pediatric population
Who may be able to join
- long-life catheter (midline, piccline, central venous catheter)
- placed in operating room
- by anesthesist
- in pédiatric population: 0 to 18 years
Who cannot join
- more than 18 years
- peripheral venous access
- not placed by anesthesist
- placed outside operating room
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Catheter Dysfunction
- Being tested
- catheter dysfunction
- Keywords
- pediatric, thrombotic, catheter infection, mechanical complication of catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter dysfunctionOther
prevalence of catheter dysfunction
| Study group | Role | What they receive |
|---|---|---|
| pediatric population | pediatric population of CHU of Nancy, France. Receives: Other: catheter dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of premature withdrawals of long-term vascular device
the pourcentage of premature withdrawals of these catheters
Measured: 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
descriptive disfunction of catheter in the medical file
Measured: Baseline (J0) is the day when the catheter is placed, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Jan 2018
- Primary completion1 Jan 2018
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter DysfunctionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOUAZIZ Hervé, Central Hospital, Nancy, France
- Investigators
- Hervé Bouaziz, PH-D, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005598
- Sponsor's protocol ID
- 2021PI133
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Venous Catheterization in Pediatric Anesthesia: Prevalence and Risk Factors of Dysfunction.
- ClinicalTrials.gov ID
- NCT05005598
- Acronym / sponsor ID
- 2021PI133
- Conditions
- Catheter Dysfunction
- Keywords
- pediatric, thrombotic, catheter infection, mechanical complication of catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric population | – | Other: catheter dysfunctionpediatric population of CHU of Nancy, France. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric population
Key inclusion criteria (4 listed)
- long-life catheter (midline, piccline, central venous catheter)
- placed in operating room
- by anesthesist
- in pédiatric population: 0 to 18 years
Key exclusion criteria (4 listed)
- more than 18 years
- peripheral venous access
- not placed by anesthesist
- placed outside operating room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catheter dysfunctionprevalence of catheter dysfunction | Other | pediatric population |
Primary outcome
prevalence of premature withdrawals of long-term vascular device
Time frame: Baseline (J0) is the day when the catheter is placed, up to 1 year
the pourcentage of premature withdrawals of these catheters
1 secondary outcome
identify risk factors associated to premature withdrawal long-life catheter
Time frame: Baseline (J0) is the day when the catheter is placed, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hervé Bouaziz, PH-D principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter Dysfunction, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of premature withdrawals of long-term vascular device (time frame: Baseline (J0) is the day when the catheter is placed, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.