NCT03680209

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2019

Completed
Last Updated

June 24, 2019

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

June 13, 2018

Last Update Submit

June 21, 2019

Conditions

Nurse's RoleSimulationArteriovenous Fistula

Keywords

Task trainningProcedural simulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Adverse events related to AVF puncture during a hemodialysis session

    25 days

  • Adverse events related to AVF puncture during a hemodialysis session

    25 days

Interventions

SimulationOTHER

pre-training observation training post training observation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who come to dialysis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, France

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Erwan Guillouët

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2018

First Posted

September 21, 2018

Study Start

April 3, 2018

Primary Completion

June 13, 2019

Study Completion

June 13, 2019

Last Updated

June 24, 2019

Record last verified: 2018-09

Locations

FR(1)