Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver

NCT ID: NCT03355508

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-29

Study Completion Date

2021-02-28

Brief Summary

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40000 patients are hemodialysis each year in France .

In the case of chronic care, 78% of patients have an arteriovenous fistula. In order to perform the hemodialysis session, 2 techniques of puncture of the fistula are possible:

* Bevel puncture upwards then flipping the needle
* or puncture bevel down. At present, there is no consensus or study on the technique of puncture fistula which generates different professional practices.

Detailed Description

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Conditions

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Arterio-venous Fistula, Puncture, Chronic Desease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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puncture bevel up

Group Type OTHER

pucture in the arteriovenous fistula

Intervention Type DEVICE

The compression time will be measured with a stopwatch so that it is objective and accurate, although the compression times range from minute to minute.

An initial 2-week observation phase (phase 1) will establish a reference time for each patient using the most common puncture technique in the department: bevel up.

We will evaluate the patient's reference time by counting the time of compression using a stopwatch for 2 weeks (ie 6 sessions) and we will take an average.

A draw will determine for each patient the order in which the direction of the needles will be used.

After this determination of the reference time, the patient will enter two successive phases where it will be punctured bevel up (phase 2) and then down (phase 3) or vice versa following the draw.

puncture bevel domn

Group Type OTHER

pucture in the arteriovenous fistula

Intervention Type DEVICE

The compression time will be measured with a stopwatch so that it is objective and accurate, although the compression times range from minute to minute.

An initial 2-week observation phase (phase 1) will establish a reference time for each patient using the most common puncture technique in the department: bevel up.

We will evaluate the patient's reference time by counting the time of compression using a stopwatch for 2 weeks (ie 6 sessions) and we will take an average.

A draw will determine for each patient the order in which the direction of the needles will be used.

After this determination of the reference time, the patient will enter two successive phases where it will be punctured bevel up (phase 2) and then down (phase 3) or vice versa following the draw.

Interventions

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pucture in the arteriovenous fistula

The compression time will be measured with a stopwatch so that it is objective and accurate, although the compression times range from minute to minute.

An initial 2-week observation phase (phase 1) will establish a reference time for each patient using the most common puncture technique in the department: bevel up.

We will evaluate the patient's reference time by counting the time of compression using a stopwatch for 2 weeks (ie 6 sessions) and we will take an average.

A draw will determine for each patient the order in which the direction of the needles will be used.

After this determination of the reference time, the patient will enter two successive phases where it will be punctured bevel up (phase 2) and then down (phase 3) or vice versa following the draw.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient in chronic renal failure treated by hemodialysis with native arteriovenous fistula as a vascular approach.
* Adult of age and sex indifferent.
* Normal puncture of the fistula with two needles (bipuncture).
* Fistula use for more than 3 months.
* Beneficiary of Medicare or State Medical Aid.
* No opposition to participation in the study.

Exclusion Criteria

* Patient who does not speak and does not understand French.
* Hemodialysis patient awaiting a transplant by a living donor.
* Patient with more than 2 AVF dilatations in the last 6 months.
* Patient with prosthetic arteriovenous fistula.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poissy-Saint Germain Hospital

OTHER

Sponsor Role lead

Responsible Party

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Valérie LOIZEAU

Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CH Poissy st Germain

Poissy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Loizeau Valerie

Role: CONTACT

Phone: 0139274727

Email: [email protected]

Facility Contacts

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Loizeau Valerie

Role: primary

Other Identifiers

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TECHFAVHEMO

Identifier Type: -

Identifier Source: org_study_id