NCT05799989

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

March 23, 2023

Last Update Submit

June 9, 2023

Conditions

Catheter Complications

Keywords

intravenousintraarterialcatheterfixationwithdrawaldislocation

Outcome Measures

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

    In 30 days after catheter insertion

Secondary Outcomes (3)

  • Incidence of local infectious complications

    In 30 days after catheter insertion

  • Incidence of systemic infectious complications

    In 30 days after catheter insertion

  • Incidence of thrombotic complications

    In 30 days after catheter insertion

Study Arms (2)

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

Surgical fixationPROCEDURE

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

Surgical fixation
Atraumatic fixationPROCEDURE

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

Atraumatic fixation

Eligibility Criteria

AgeUp to 19 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brno University Hospital - Academic Centre for Malignant Hyperthermia of Masaryk University Brno

Brno, South Moravian, 62500, Czechia

RECRUITING

MeSH Terms

Conditions

Joint Dislocations

Interventions

Surgical Fixation Devices

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Petr Stourac, prof. MD., Ph.D., MBA

    Department of paediatric anaesthesia and intensive care medicine

    STUDY CHAIR

Central Study Contacts

Jozef UO Klučka, assoc.prof.MD., Ph.D.

CONTACT

+420532234696klucka.jozef@fnbrno.cz

Marketa Říhová, Mgr., MBA

CONTACT

+420532234404rihova.marketa@fnbrno.cz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 5, 2023

Study Start

June 1, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

June 12, 2023

Record last verified: 2023-06

Locations

CZ(1)