Catheter Dislocation and the Influence of Different Catheter Fixation in Pediatric Patients (FIXATION)

June 9, 2023 updated by: Petr Štourač, MD, Brno University Hospital

Catheter Dislocation and the Influence of Different Catheter Fixation in Pediatric Patients: Prospective Observational Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • South Moravian Region
      • Brno, South Moravian Region, Czechia, 62500
        • Recruiting
        • Brno University Hospital - Academic Centre for Malignant Hyperthermia of Masaryk University Brno
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 19 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical fixation
Pediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation
Procedure: Surgical fixation
Pediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation
Atraumatic fixation
Pediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation
Procedure: Atraumatic fixation
Pediatric patients with intravenous and/or intraarterial catheter in situ secured with atraumatic fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of catheter extraction/dislocation
Time Frame: In 30 days after catheter insertion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of local infectious complications
Time Frame: In 30 days after catheter insertion
The incidence of local infectious complications will be evaluated between the group of surgical and atraumatic catheter fixation
In 30 days after catheter insertion
Incidence of systemic infectious complications
Time Frame: In 30 days after catheter insertion
The incidence of systemic infectious complications will be evaluated between the group of surgical and atraumatic catheter fixation
In 30 days after catheter insertion
Incidence of thrombotic complications
Time Frame: In 30 days after catheter insertion
The incidence of thrombotic complications will be evaluated between the group of surgical and atraumatic catheter fixation
In 30 days after catheter insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brno University Hospital

Collaborators

Masaryk University

Investigators

  • Study Chair: Petr Stourac, prof. MD., Ph.D., MBA, Department of paediatric anaesthesia and intensive care medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KDAR FIXATION 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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