Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients (SIMFAV2)
Primary Purpose
Nursing Caries, Arteriovenous Fistula, Simulation-based Training
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
simulation-based training
Sponsored by

About this trial
This is an interventional other trial for Nursing Caries
Eligibility Criteria
Inclusion Criteria:
- Adult patients
- Arteriovenous fistula puncture in the hemodialysis unit of the nephrology, dialysis, transplantation department
- Nurses trained in hemodialysis
Exclusion Criteria:
- 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
Sites / Locations
- Center hospital of Alençon
- University hospital center of CaenRecruiting
- Private Hospital St Martin
- Center Hospital of Dieppe
- Center Hospital of Flers
- ANIDERRecruiting
- Center Hospital of Lisieux
- Anider AlenconRecruiting
- Center Hospital of Memorial United States of St LoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Simulation
Control
Arm Description
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
Theoretical training for nurses in e-learning on : arteriovenous fistula puncture use of ultrasound with echoreferencing and ultrasound guidance therapeutic communication
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05302505
Brief Title
Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients
Acronym
SIMFAV2
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nursing Caries, Arteriovenous Fistula, Simulation-based Training
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Simulation
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Theoretical training for nurses in e-learning on :
arteriovenous fistula puncture
use of ultrasound with echoreferencing and ultrasound guidance
therapeutic communication
Intervention Type
Other
Intervention Name(s)
simulation-based training
Intervention Description
Based-simulation training for nurses in a simulation center : puncture of arteriovenous fistula and utilization of echograph and conversational hypnosis
Primary Outcome Measure Information:
Title
Number of adverse events occurring during arteriovenous fistula puncture (comparison of the percentages of event occurrence)
Description
defined by one of the following events:
Unipuncture failure
Bipuncture failure
Simple hematoma
Hematoma not allowing continued dialysis
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients
Arteriovenous fistula puncture in the hemodialysis unit of the nephrology, dialysis, transplantation department
Nurses trained in hemodialysis
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erwan Guillouët
Phone
+33231063403
Email
guillouet-e@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Clémence Tomadesso
Phone
+33231063106
Email
tomadesso-c@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erwan Guillouët
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center hospital of Alençon
City
Alençon
ZIP/Postal Code
61000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erick Cardineau, MD
Phone
02 33 32 30 30
Email
ecardineau@ch-alencon.fr
Facility Name
University hospital center of Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erwan Guillouët
Email
guillouet-e@chu-caen.fr
Facility Name
Private Hospital St Martin
City
Caen
ZIP/Postal Code
14050
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anaïs BENABED, MD
Phone
0 826 46 14 00
Facility Name
Center Hospital of Dieppe
City
Dieppe
ZIP/Postal Code
76200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EMMANUELLE HECQUET, MD
Phone
0232147248
Email
ehecquet@ch-dieppe.fr
Facility Name
Center Hospital of Flers
City
Flers
ZIP/Postal Code
61104
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor GUEUTIN, MD
Phone
02 31 06 31 06
Email
gueutin-v@chu-caen.fr
Facility Name
ANIDER
City
Hérouville-Saint-Clair
ZIP/Postal Code
14200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PATRICK HENRI, MD
Phone
02 31 46 97 97
Email
henri-p@chu-caen.fr
Facility Name
Center Hospital of Lisieux
City
Lisieux
ZIP/Postal Code
14100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loay Al Moussalla, MD
Phone
02 31 61 31 55
Email
I.almoussalla@ch-lisieux.fr
Facility Name
Anider Alencon
City
Saint-Germain-du-Corbéis
ZIP/Postal Code
61000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Pierre DIONE, MD
Phone
0233323097
Email
jpdione@ch-alencon.fr
Facility Name
Center Hospital of Memorial United States of St Lo
City
Saint-Lô
ZIP/Postal Code
50000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elie ZAGDOUN, MD
Phone
02 33 06 33 33
Email
elie.zagdoun@ch-stlo.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients
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