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

Catheter Complications Clinical Trial

— FIXATION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799989
• Other study ID #: KDAR FIXATION 2023
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2023
• Source: Brno University Hospital
• Contact: Jozef UO Klucka, assoc.prof.MD., Ph.D.
• Phone: +420532234696
• Email: klucka.jozef[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: N/A to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter Complications

Intervention

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 atraumatic fixation

Locations

Country	Name	City	State
Czechia	Brno University Hospital - Academic Centre for Malignant Hyperthermia of Masaryk University Brno	Brno	South Moravian Region

Sponsors (2)

Lead Sponsor	Collaborator
Brno University Hospital	Masaryk University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of local infectious complications	The incidence of local infectious complications will be evaluated between the group of surgical and atraumatic catheter fixation	In 30 days after catheter insertion
Secondary	Incidence of systemic infectious complications	The incidence of systemic infectious complications will be evaluated between the group of surgical and atraumatic catheter fixation	In 30 days after catheter insertion
Secondary	Incidence of thrombotic complications	The incidence of thrombotic complications will be evaluated between the group of surgical and atraumatic catheter fixation	In 30 days after catheter insertion