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RecruitingNCT05799989FIXATIONUpdated Jun 12, 2023

Catheter Dislocation and the Influence of Different Catheter Fixation in Pediatric Patients

An observational study in Catheter Complications, sponsored by Brno University Hospital. Recruiting at 1 site in Czechia. Open to participants aged Up to 19 Years. Per ClinicalTrials.gov, last updated 2023-06-12.

Sponsored by Brno University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
Up to 19 Years
Sex
All
01

Study summary

Insertion of intravenous or intra-arterial catheter is one of the most common procedures in anesthesiology and intensive care medicine. After successful insertion, proper catheter fixation is required to maintain the catheter correct position with the aim to preserve catheter patency, prevent excessive movements of catheter or even iatrogenic catheter extraction/dislocation. Beside the historically preferred surgical fixation to the skin of the patient (invasive method, repeated percutaneous punction), atraumatic fixation by special dressing is currently available in clinical practice. In pediatric patients, due to limited cooperation, higher risk of dislocation exists.

Read the detailed description

Pediatric patients with intravenous and/or intraarterial catheters with estimated length of insertion over 72 hours will be included into the trial.Type of catheter fixation (surgical versus atraumatic) will be evaluated. Demographic data, local and systemic complication between the group of surgical fixation and atraumatic fixation will be evaluated.

02

Conditions studied

  • Catheter Complications

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Keywords

  • intravenous
  • intraarterial
  • catheter
  • fixation
  • withdrawal
  • dislocation
03

In context

Joint Dislocations

98 studies on the registry are indexed under Joint Dislocations; 21 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 37 observational studies indexed under Joint Dislocations.

Browse Joint Dislocations studies →

Lead sponsor

Brno University Hospital is the lead sponsor of 91 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 19 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

pediatric patients with intravenous/intraarterial catheter secured at Departement of pediatric anesthesiology and intensive care medicine

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pediatric patients with intravenous/intraarterial catheter secured at Departement of pediatric anesthesiology and intensive care medicine
  • estimated length of catheter left in place longer than 72 hours

Exclusion criteria

Exclusion Criteria:

  • estimated length of catheter left in place shorter than 72 hours
  • impossible patient´s evaluation after catheter insertion
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Surgical fixation

    Pediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation

    Procedure: Surgical fixation

  • Atraumatic fixation

    Pediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation

    Procedure: Atraumatic fixation

Interventions

  • ProcedureSurgical fixation

    Pediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation

  • ProcedureAtraumatic fixation

    Pediatric patients with intravenous and/or intraarterial catheter in situ secured with atraumatic fixation

06

What researchers measure

Primary outcomes

  1. Incidence of catheter extraction/dislocation

    The incidence of catheter extraction/dislocation will be evaluated between the group of surgical and atraumatic catheter fixation

    Time frame: In 30 days after catheter insertion

Secondary outcomes

  1. Incidence of local infectious complications

    The incidence of local infectious complications will be evaluated between the group of surgical and atraumatic catheter fixation

    Time frame: In 30 days after catheter insertion

  2. Incidence of systemic infectious complications

    The incidence of systemic infectious complications will be evaluated between the group of surgical and atraumatic catheter fixation

    Time frame: In 30 days after catheter insertion

  3. Incidence of thrombotic complications

    The incidence of thrombotic complications will be evaluated between the group of surgical and atraumatic catheter fixation

    Time frame: In 30 days after catheter insertion

07

Study locations

1 of 1 sites recruiting
  • Brno University Hospital - Academic Centre for Malignant Hyperthermia of Masaryk University Brno
    Brno, South Moravian Region 62500, Czechia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2023 (actual). Primary completion is estimated for Apr 2024, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2023
First posted
Apr 5, 2023
StartActual
Jun 1, 2023
Primary completionEst.
Apr 30, 2024
CompletionEst.
Apr 30, 2024
Last update
Jun 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05799989
Lead sponsor
Brno University Hospital
Collaborators
Masaryk University
Responsible party
Petr Štourač, MD (Clinical Professor, Brno University Hospital) — Principal investigator
First posted
Apr 5, 2023
Start date
Jun 1, 2023
Primary completion
Apr 30, 2024 (estimated)
Completion
Apr 30, 2024 (estimated)
Last update
Jun 12, 2023

Study contacts

Jozef UO Klučka, assoc.prof.MD., Ph.D.
Contact
klucka.jozef@fnbrno.cz
+420532234696
Marketa Říhová, Mgr., MBA
Contact
rihova.marketa@fnbrno.cz
+420532234404
Petr Stourac, prof. MD., Ph.D., MBA
study chair · Department of paediatric anaesthesia and intensive care medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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