Creation of a Vascular Access Specialist Teams Within an Interventional Vascular Radiology Service: a Retrospective Observational Study

Completed

• Conditions: Vascular Access Complication; Nurses; Nurse; Vascular Access Devices

• Registration Number: NCT06770361
• Lead Sponsor: Hospital Arnau de Vilanova

Brief Summary

A study will be carried out to observe catheters (polyurethane tubes inserted into veins) over a period of five years. The study will look at any problems related to these devices, especially those put in at a specific hospital unit (vascular interventional radiology service) of the Arnau de Vilanova hospital in Lleida (Catalonia, Spain).

Detailed Description

Introduction: Vascular Access Specialist Teams (VAST) have been implemented in numerous hospitals worldwide with excellent results. Although these vary in structure and function the purpose is the same in all of them, the improvement in cannulation and comprehensive cures of vascular access devices (VADs) based on the best scientific evidence.

Hypothesis: The creation of a VAST within an Interventional Vascular Radiology (IVR) service reduces the main complications related to VADs and contributes to improving the quality and safety standards necessary in the implantation and treatment of these devices Objective: To describe the creation of a VAST within an IVR service in a second level hospital. In addition, it is expected to analyze the prevalence of VADs placement and success rate, to determine the number of catheter-related bacteremia's and to know the number of failures of VADs cannulated in the EIAV in acute hospitalized patients.

Methodology: Retrospective observational study. A description will be made of the characteristics of the VAST, the implanted VADs and the main associated complications.

Expected results: We expect to describe the structure of a VAST within an IVR service and to analyze the prevalence of VADs placement and success rate, to determine the number of catheter-related bacteremia's and to know the number of failures of VADs cannulated in the VAST in acute hospitalized patients.

Clinical implication: The study will help to improve current VAST and to reduce the difficulties in the creation of future VAST, as well as to clarify the need for these specialized teams, which aim to improve the quality and safety standards necessary for VADs implantation and treatment.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-01-31
• Study Completion: 2024-06-15
• Study First Submitted: 2024-12-27
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1588

Inclusion Criteria

• Patients over 18 years of age
• Admitted to a hospitalisation unit
• Requiring VAD cannulation for intravenous treatment or due to poor venous access, in accordance with the protocol of insertion criteria of the hospital.

Exclusion Criteria

• Patients who underwent initial evaluation and cannulation was not attempted are excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of complications that result in the malfunction of venous catheters cannulated using the ultrasound-guided technique in an interventional vascular radiology unit, necessitating their removal or replacement.	From date of study entry (day of catheter insertion) to the day of withdrawal from any cause, evaluated up to 111 weeks.	The present study aims to provide a comprehensive overview of the number of cases in which patients had to undergo catheter removal or replacement due to catheter dysfunction. This dysfunction can be categorised into two distinct types: immediate complications, which include pain, bleeding, haemorrhage, haematoma, difficulty in progressing the guidewire and/or catheter, and arrhythmia, among others; and late complications, which encompass phlebitis, obstruction, extravasation, thrombosis, and infection, to name a few. Furthermore, the list should include the name of complications associated with premature catheter removal, and the rate of complications per 1000 catheter days for catheters cannulated in the unit should be described.

Secondary Outcome Measures

Name	Time	Method
Number of catheter-related bloodstream infections (CRBSI)	From date of study entry (day of catheter insertion) to the day of withdrawal from any cause, evaluated up to 111 weeks.	The number of catheter-related bloodstream infections (CRBSI) must be described and analysed, as well as the samples and the types of bacteria, viruses or fungi confirmed. The rate of CRBSI per 1000 catheter days in catheters catheterised in the unit must be defined.
Provide the success rate of ultrasound-guided cannulation of vascular access team.	From date of study entry (day of catheter insertion) to the day of withdrawal from any cause, evaluated up to 111 weeks.	The number of catheters that have had no immediate or late complications and have been able to complete treatment without problems should be provided. In addition, the type of catheter (mini-midline, midline, PICC, etc.) cannulated by the vascular access team and the success rate of each should be described.

Trial Locations

Locations (1)

Hospital Universitari Arnau de Vilanova; 🇪🇸 Lleida, Cataluña, Spain