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

June 21, 2019 updated by: University Hospital, Caen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • Caen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who come to dialysis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
25 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Erwan Guillouët, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2018

Primary Completion (Actual)

June 13, 2019

Study Completion (Actual)

June 13, 2019

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

September 20, 2018

First Posted (Actual)

September 21, 2018

Study Record Updates

Last Update Posted (Actual)

June 24, 2019

Last Update Submitted That Met QC Criteria

June 21, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A00072-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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