NCT06770361

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,588

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

December 27, 2024

Last Update Submit

January 7, 2025

Conditions

Keywords

Nurse SpecialistsVascular Access TeamVascular Access Specialist TeamsVATVAST

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    From date of study entry (day of catheter insertion) to the day of withdrawal from any cause, evaluated up to 111 weeks.

Secondary Outcomes (2)

  • 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.

  • 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.

Study Arms (1)

Hospitalised patients who had undergone an ultrasound-guided catheter cannulation.

Hospitalised patients who had undergone ultrasound-guided catheter cannulation by the vascular access team (VAT) of the Hospital Universitari Arnau de Vilanova (HUAV) of Lleida, integrated in an interventional vascular radiology unit, from 12 September 2017 (day of creation of the unit) until 31 December 2022.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

During the study period, 1,588 consultations were recorded in the unit for VAD cannulation, originating from various hospitalisation units.A non-probabilistic convenience sampling method was employed, and all patients over the age of 18 who were admitted to a hospitalisation unit and required VAD cannulation for intravenous treatment or due to poor venous access were included in the study, in accordance with the hospital's insertion criteria protocol. Patients who underwent the initial assessment but for whom cannulation was not attempted were excluded from the study.Cannulations were performed according to a checklist and with the assistance of ultrasound as a guiding technique.The VAST was created within an IVR service, with specific characteristics and the possibility of being able to channel the VADs in a room with a laminar ventilation system and a fluoroscope arch.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Arnau de Vilanova

Lleida, Catalonia, 25198, Spain

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registred Nurse (RN) and Master of Science (MSc)

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 13, 2025

Study Start

November 1, 2023

Primary Completion

January 31, 2024

Study Completion

June 15, 2024

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations