Vascular Access ComplicationANGIO-ETINCT06770361
Creation of a Vascular Access Specialist Teams Within an Interventional Vascular Radiology Service: a Retrospective Observational Study
An observational study of Vascular Access Complication and Nurse, run by Hospital Arnau de Vilanova at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Nurse, Vascular Access Devices
- How many people
- 1,588 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who underwent initial evaluation and cannulation was not attempted are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Vascular Access Complication, Nurse, Vascular Access Devices, Nurses
- Keywords
- Nurse Specialists, Vascular Access Team, Vascular Access Specialist Teams, VAT, VAST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
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.
Measured: From date of study entry (day of catheter insertion) to the day of withdrawal from any cause, evaluated up to 111 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Nov 2023
- Primary completion31 Jan 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Arnau de Vilanova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferran Padilla Nula, Hospital Arnau de Vilanova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770361
- Sponsor's protocol ID
- 02/23
- Acronym
- ANGIO-ETI
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Vascular Access Specialist Teams Within an Interventional Vascular Radiology Service: a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT06770361
- Acronym / sponsor ID
- ANGIO-ETI / 02/23
- Conditions
- Vascular Access Complication, Nurse, Vascular Access Devices, Nurses
- Keywords
- Nurse Specialists, Vascular Access Team, Vascular Access Specialist Teams, VAT, VAST
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,588 participants (actual)
- Lead sponsor
- Hospital Arnau de VilanovaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who underwent initial evaluation and cannulation was not attempted are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 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.
2 secondary outcomes
Number of catheter-related bloodstream infections (CRBSI)
Time frame: 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.
Time frame: From date of study entry (day of catheter insertion) to the day of withdrawal from any cause, evaluated up to 111 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Access Complication and Nurse, run by Hospital Arnau de Vilanova at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From date of study entry (day of catheter insertion) to the day of withdrawal from any cause, evaluated up to 111 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.