Nursing CariesSIMFAV2NCT05302505
Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients
A study testing simulation-based training in people with Nursing Caries and Arteriovenous Fistula, run by University Hospital, Caen at 9 sites in France.
Trial summary
Currently, the technique of arteriovenous fistula puncture is transmitted by companionship within hemodialysis units. Although the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still lacking to standardize fine practices such as the relative position of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nursing Caries, Arteriovenous Fistula, Simulation-based Training
- What is being tested?
- simulation-based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,600 participants
- Where
- 9 sitesFrance
- Study dates
- 5 Sep 2022to 30 Sep 2024
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients
- Arteriovenous fistula puncture in the hemodialysis unit of the nephrology, dialysis, transplantation department
- Nurses trained in hemodialysis
Who cannot join
- arteriovenous fistula puncture in the emergency area/foldout of the unit
- Refuse of data collection
- Not speak French
- Minor
- Under guardianship or unable to give informed consent
- Not enrolled in a social security plan
- Pregnant or breastfeeding women
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Center hospital of Alençon
Alençon, 61000
University hospital center of Caen
Caen, 14000
Private Hospital St Martin
Caen, 14050
Center Hospital of Dieppe
Dieppe, 76200
Center Hospital of Flers
Flers, 61104
ANIDER
Hérouville-Saint-Clair, 14200
Center Hospital of Lisieux
Lisieux, 14100
Anider Alencon
Saint-Germain-du-Corbéis, 61000
Center Hospital of Memorial United States of St Lo
Saint-Lô, 50000
About this study
Official title: Impact of Simulation-based Training in Addition to Theoretical Training Versus Theoretical Training Alone for Nurses on the Occurring of Adverse Events Related to Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients.
Currently, the technique of arteriovenous fistula puncture is transmitted by companionship within hemodialysis units. Although the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still lacking to standardize fine practices such as the relative position of the needles, the angle of attack of the needle at puncture, the position of the bevel at the time of puncture and once the needle is in the vascular lumen.
The training of professionals using a simulation-based training program on the approach to arteriovenous fistula puncture, in a process of optimizing practices and continuous improvement of care, while respecting the principles of andragogy, seems to be a suitable tool. This program is built in a multi-professional team from nephrology, nursing and health simulation.
Read the detailed description
Currently, the technique of arteriovenous fistula puncture is transmitted by companionship within hemodialysis units. Although the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still lacking to standardize fine practices such as the relative position of the needles, the angle of attack of the needle at puncture, the position of the bevel at the time of puncture and once the needle is in the vascular lumen.
The training of professionals using a simulation-based training program on the approach to arteriovenous fistula puncture, in a process of optimizing practices and continuous improvement of care, while respecting the principles of andragogy, seems to be a suitable tool. This program is built in a multi-professional team from nephrology, nursing and health simulation.
The aim of this study is to evaluate whether a simulation-based training program for nurses, concerning arteriovenous fistula puncture puncture, would allow to decrease the adverse events related to punctures.
The investigators propose a prospective, comparative, randomized, multicenter study involving 8 hemodialysis centers. The primary objective is to compare the number of arteriovenous fistula puncture-related adverse events between:
- A group receiving theoretical training + simulation-based training (4 centers)
- A group receiving theoretical training only (4 centers)
Will be included all adult patients who are to receive an arteriovenous fistula puncture puncture by a hemodialysis-trained IDE, during a scheduled chronic dialysis session.
This study is innovative for several reasons:
- simulation-based training in continuing education, among professionals is not widely used
- simulation-based training in continuing education allows the conceptualization of the team approach to VF by its modeling in simulation
- the evaluation of the direct benefit of the training on the patient, a Kirkpatrick level 4, is very little described in the literature.
Thus, this study is of major interest to patients managed in nephrology with the simulation-based training tool.
- Being tested
- simulation-based training
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation-based trainingOther
Based-simulation training for nurses in a simulation center : puncture of arteriovenous fistula and utilization of echograph and conversational hypnosis
| Study group | Role | What they receive |
|---|---|---|
| Simulation | Experimental | Theoretical training in e-learning for nurses on :
* arteriovenous fistula puncture
* use of ultrasound with echoreferencing and ultrasound guidance
* therapeutic communication
And simulation-based training (procedural) on :
* arteriovenous fistula puncture
* use of ultrasound with echoreferencing and ultrasound guidance
* therapeutic communication Receives: Other: simulation-based training |
| Control | No intervention | Theoretical training for nurses in e-learning on : * arteriovenous fistula puncture * use of ultrasound with echoreferencing and ultrasound guidance * therapeutic communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events occurring during arteriovenous fistula puncture (comparison of the percentages of event occurrence)
defined by one of the following events:
- Unipuncture failure
- Bipuncture failure
- Simple hematoma
- Hematoma not allowing continued dialysis
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start5 Sep 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwan Guillouët, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302505
- Sponsor's protocol ID
- 2021-A01813-38
- Acronym
- SIMFAV2
- Status last verified
- May 2024
- First submitted
- 2 Mar 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guillouet E, Tomadesso C, Flores BA, Henri P, Lanot A, Morello R, Guillouet S. Impact of simulation-based training in addition to theoretical training versus theoretical training of nurses alone in the occurrence of adverse events related to arteriovenous fistula puncture in chronic hemodialysis patients: study for a cluster randomized controlled trial (SIMFAV2). Trials. 2023 Aug 7;24(1):500. doi: 10.1186/s13063-023-07513-8.
PubMed 37550740
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Simulation-based Training in Addition to Theoretical Training Versus Theoretical Training Alone for Nurses on the Occurring of Adverse Events Related to Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT05302505
- Acronym / sponsor ID
- SIMFAV2 / 2021-A01813-38
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,600 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 31 Mar 2022 (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.
Currently, the technique of arteriovenous fistula puncture is transmitted by companionship within hemodialysis units. Although the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still lacking to standardize fine practices such as the relative position of the needles, the angle of attack of the needle at puncture, the position of the bevel at the time of puncture and once the needle is in the vascular lumen.
The training of professionals using a simulation-based training program on the approach to arteriovenous fistula puncture, in a process of optimizing practices and continuous improvement of care, while respecting the principles of andragogy, seems to be a suitable tool. This program is built in a multi-professional team from nephrology, nursing and health simulation.
Detailed description
Currently, the technique of arteriovenous fistula puncture is transmitted by companionship within hemodialysis units. Although the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still lacking to standardize fine practices such as the relative position of the needles, the angle of attack of the needle at puncture, the position of the bevel at the time of puncture and once the needle is in the vascular lumen.
The training of professionals using a simulation-based training program on the approach to arteriovenous fistula puncture, in a process of optimizing practices and continuous improvement of care, while respecting the principles of andragogy, seems to be a suitable tool. This program is built in a multi-professional team from nephrology, nursing and health simulation.
The aim of this study is to evaluate whether a simulation-based training program for nurses, concerning arteriovenous fistula puncture puncture, would allow to decrease the adverse events related to punctures.
The investigators propose a prospective, comparative, randomized, multicenter study involving 8 hemodialysis centers. The primary objective is to compare the number of arteriovenous fistula puncture-related adverse events between:
- A group receiving theoretical training + simulation-based training (4 centers)
- A group receiving theoretical training only (4 centers)
Will be included all adult patients who are to receive an arteriovenous fistula puncture puncture by a hemodialysis-trained IDE, during a scheduled chronic dialysis session.
This study is innovative for several reasons:
- simulation-based training in continuing education, among professionals is not widely used
- simulation-based training in continuing education allows the conceptualization of the team approach to VF by its modeling in simulation
- the evaluation of the direct benefit of the training on the patient, a Kirkpatrick level 4, is very little described in the literature.
Thus, this study is of major interest to patients managed in nephrology with the simulation-based training tool.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation | Experimental | Other: simulation-based trainingTheoretical training in e-learning for nurses on : * arteriovenous fistula puncture * use of ultrasound with echoreferencing and ultrasound guidance * therapeutic communication And simulation-based training (procedural) on : * arteriovenous fistula puncture * use of ultrasound with echoreferencing and ultrasound guidance * therapeutic communication |
| Control | No intervention | –Theoretical training for nurses in e-learning on : * arteriovenous fistula puncture * use of ultrasound with echoreferencing and ultrasound guidance * therapeutic communication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Arteriovenous fistula puncture in the hemodialysis unit of the nephrology, dialysis, transplantation department
- Nurses trained in hemodialysis
Key exclusion criteria (7 listed)
- arteriovenous fistula puncture in the emergency area/foldout of the unit
- Refuse of data collection
- Not speak French
- Minor
- Under guardianship or unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simulation-based trainingBased-simulation training for nurses in a simulation center : puncture of arteriovenous fistula and utilization of echograph and conversational hypnosis | Other | Simulation |
Primary outcome
Number of adverse events occurring during arteriovenous fistula puncture (comparison of the percentages of event occurrence)
Time frame: 45 days
defined by one of the following events: * Unipuncture failure * Bipuncture failure * Simple hematoma * Hematoma not allowing continued dialysis
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 1 May 2026.
- Derived from this study: PubMed 37550740Guillouet E, Tomadesso C, Flores BA, Henri P, Lanot A, Morello R, Guillouet S. Impact of simulation-based training in addition to theoretical training versus theoretical training of nurses alone in the occurrence of adverse events related to arteriovenous fistula puncture in chronic hemodialysis patients: study for a cluster randomized controlled trial (SIMFAV2). Trials. 2023 Aug 7;24(1):500. doi: 10.1186/s13063-023-07513-8.
- Individual participant dataSharing planned: Undecided
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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.
Erwan Guillouët principal investigator
University Hospital, Caen
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation-based training in people with Nursing Caries and Arteriovenous Fistula, run by University Hospital, Caen at 9 sites in France.
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 7 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
Number of adverse events occurring during arteriovenous fistula puncture (comparison of the percentages of event occurrence) (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05302505, which also lists 1 linked publication.
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 1 May 2026.