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

Not Applicable

• Conditions: Arterio-venous Fistula, Puncture, Chronic Desease
• Interventions: Device: pucture in the arteriovenous fistula

• Registration Number: NCT03355508
• Lead Sponsor: Poissy-Saint Germain Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-09-29
• Status Verified: 2017-10
• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-11-21
• Last Update Submitted: 2017-11-21
• Study First Posted: 2017-11-28
• Last Update Posted: 2017-11-28
• Primary Completion: 2020-09
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
puncture bevel domn	pucture in the arteriovenous fistula	-
puncture bevel up	pucture in the arteriovenous fistula	-

Primary Outcome Measures

Name	Time	Method
Compression time required for hemostasis	period of 3 weeks	The primary endpoint is the compression time required for hemostasis after needle removal, which is stable over a 3-week period.; 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 tapped bevel up (phase 2) and then down (phase 3) or vice versa following the draw.

Trial Locations

Locations (1)

CH Poissy st Germain; 🇫🇷 Poissy, France