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NCT03680209 Clinical Trial

Training Procedural Simulation of Nurses in Reducing Complications Related to Arteriovenous Fistula Puncture

Nurse's Role Clinical Trial

— SIMFAV  

Official title:
Interest of Training in Procedural Simulation of Nurses in Reducing Complications Related to Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03680209
Other study ID # 2018-A00072-53
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 3, 2018
Est. completion date June 13, 2019

Study information
Verified date September 2018
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Interest of training in procedural simulation of nurses in the reduction of complications related to arteriovenous fistula puncture in hemodialysis patients

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

Recruitment information / eligibility
Status Completed
Enrollment 1280
Est. completion date June 13, 2019
Est. primary completion date June 13, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients whose nurse is trained in hemodialysis receiving a FAV puncture in the hemodialysis unit of the nephrology department, dialysis, transplantation

Exclusion Criteria:

- Patients with AVF puncture in the emergency / withdrawal area of the nephrology department, dialysis, transplantation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Simulation
pre-training observation training post training observation

Locations
Country Name City State
France Caen University Hospital Caen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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		 25 days
Secondary Adverse events related to AVF puncture during a hemodialysis session Number of perdialytic bleeding : accidental removal of the needle 25 days
Secondary Adverse events related to AVF puncture during a hemodialysis session Pain score (EN digital scale) felt at the time of puncture 25 days
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