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

Recruiting

• Conditions: Catheter Complications
• Interventions: Procedure: Surgical fixation; Procedure: Atraumatic fixation

• Registration Number: NCT05799989
• Lead Sponsor: Brno University Hospital

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.

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 Timeline

• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-05
• Status Verified: 2023-06
• Study Start: 2023-06-01
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-12
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical fixation	Surgical fixation	Pediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation
Atraumatic fixation	Atraumatic fixation	Pediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation

Primary Outcome Measures

Name	Time	Method
Incidence of catheter extraction/dislocation	In 30 days after catheter insertion	The incidence of catheter extraction/dislocation will be evaluated between the group of surgical and atraumatic catheter fixation

Secondary Outcome Measures

Name	Time	Method
Incidence of thrombotic complications	In 30 days after catheter insertion	The incidence of thrombotic complications will be evaluated between the group of surgical and atraumatic catheter fixation
Incidence of local infectious complications	In 30 days after catheter insertion	The incidence of local infectious complications will be evaluated between the group of surgical and atraumatic catheter fixation
Incidence of systemic infectious complications	In 30 days after catheter insertion	The incidence of systemic infectious complications will be evaluated between the group of surgical and atraumatic catheter fixation

Trial Locations

Locations (1)

Brno University Hospital - Academic Centre for Malignant Hyperthermia of Masaryk University Brno; 🇨🇿 Brno, South Moravian Region, Czechia