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

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ClinicalTrials.gov Identifier: NCT03680209
Recruitment Status : Completed
First Posted : September 21, 2018
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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Brief Summary:
Interest of training in procedural simulation of nurses in the reduction of complications related to arteriovenous fistula puncture in hemodialysis patients

Condition or disease Intervention/treatment
Nurse's Role Simulation Arteriovenous Fistula Other: Simulation

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1280 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Interest of Training in Procedural Simulation of Nurses in Reducing Complications Related to Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients
Actual Study Start Date : April 3, 2018
Actual Primary Completion Date : June 13, 2019
Actual Study Completion Date : June 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas

Groups and Cohorts
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Intervention Details:
  • Other: Simulation
    pre-training observation training post training observation

Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Adverse events related to AVF puncture during a hemodialysis session [ Time Frame: 25 days ]
    Number of perdialytic bleeding : accidental removal of the needle

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients who come to dialysis
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680209


Locations
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France
Caen University Hospital
Caen, France
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Principal Investigator: Erwan Guillouët University Hospital, Caen
More Information
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Additional Information:

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03680209    
Other Study ID Numbers: 2018-A00072-53
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
Task trainning
Procedural simulation
Additional relevant MeSH terms:
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Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
 Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities