Nurse's RoleSIMFAVNCT03680209
Training Procedural Simulation of Nurses in Reducing Complications Related to Arteriovenous Fistula Puncture
An observational study of Nurse's Role and Simulation, run by University Hospital, Caen at 1 site in France.
Trial summary
Interest of training in procedural simulation of nurses in the reduction of complications related to arteriovenous fistula puncture in hemodialysis patients Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Simulation, Arteriovenous Fistula
- What is being tested?
- Simulation
- How many people
- 1,280 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2018to 13 Jun 2019
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients who come to dialysis
Who may be able to join
- Patients whose nurse is trained in hemodialysis receiving a FAV puncture in the hemodialysis unit of the nephrology department, dialysis, transplantation
Who cannot join
- Patients with AVF puncture in the emergency / withdrawal area of the nephrology department, dialysis, transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Training in Procedural Simulation of Nurses in Reducing Complications Related to Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients
Interest of training in procedural simulation of nurses in the reduction of complications related to arteriovenous fistula puncture in hemodialysis patients
Read the detailed description
Primary objective :
To compare the number of complications related to arteriovenous fistula (AVF)puncture before and after a complete simulation training program, on a fistula arm of procedural simulation (conceptualization of the approach + puncture + palpation + identification + use of ultrasound)
Secondary objective (s):
Compare other adverse events related to AVF puncture during a hemodialysis session
- Conditions
- Nurse's Role, Simulation, Arteriovenous Fistula
- Being tested
- Simulation
- Keywords
- Task trainning, Procedural simulation
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationOther
pre-training observation training post training observation
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications related to arteriovenous fistula puncture (AVF)
Number of complications of fistula puncture :
either failed unipuncture puncture either failed bipunctional puncture either simple hematoma either hematoma does not allow the continuation of dialysis
Measured: 25 days
Secondary outcomes (2)
Adverse events related to AVF puncture during a hemodialysis session
Number of perdialytic bleeding : accidental removal of the needle
Measured: 25 days
Adverse events related to AVF puncture during a hemodialysis session
Pain score (EN digital scale) felt at the time of puncture
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start3 Apr 2018
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,280 participants (actual)
- Target duration
- 1 Year
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
- NCT03680209
- Sponsor's protocol ID
- 2018-A00072-53
- Acronym
- SIMFAV
- Status last verified
- Sep 2018
- First submitted
- 13 Jun 2018
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Training in Procedural Simulation of Nurses in Reducing Complications Related to Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03680209
- Acronym / sponsor ID
- SIMFAV / 2018-A00072-53
- Conditions
- Nurse's Role, Simulation, Arteriovenous Fistula
- Keywords
- Task trainning, Procedural simulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,280 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 21 Sep 2018 (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.
Interest of training in procedural simulation of nurses in the reduction of complications related to arteriovenous fistula puncture in hemodialysis patients
Detailed description
Primary objective :
To compare the number of complications related to arteriovenous fistula (AVF)puncture before and after a complete simulation training program, on a fistula arm of procedural simulation (conceptualization of the approach + puncture + palpation + identification + use of ultrasound)
Secondary objective (s):
Compare other adverse events related to AVF puncture during a hemodialysis session
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who come to dialysis
Key inclusion criteria (1 listed)
- Patients whose nurse is trained in hemodialysis receiving a FAV puncture in the hemodialysis unit of the nephrology department, dialysis, transplantation
Key exclusion criteria (1 listed)
- Patients with AVF puncture in the emergency / withdrawal area of the nephrology department, dialysis, transplantation
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 |
|---|---|---|
| Simulationpre-training observation training post training observation | Other | – |
Primary outcome
Complications related to arteriovenous fistula puncture (AVF)
Time frame: 25 days
Number of complications of fistula puncture : either failed unipuncture puncture either failed bipunctional puncture either simple hematoma either hematoma does not allow the continuation of dialysis
2 secondary outcomes
Adverse events related to AVF puncture during a hemodialysis session
Time frame: 25 days
Adverse events related to AVF puncture during a hemodialysis session
Time frame: 25 days
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 24 Jun 2019.
- Individual participant dataSharing planned: Undecided. Publication
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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
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 Nurse's Role and Simulation, run by University Hospital, Caen at 1 site 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 1 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 24 Jun 2019. 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 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?
Complications related to arteriovenous fistula puncture (AVF) (time frame: 25 days). 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 24 Jun 2019.