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

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.

Study Overview

• Status: Unknown
• Conditions: Arterio-venous Fistula, Puncture, Chronic Desease
• Intervention / Treatment: Device: pucture in the arteriovenous fistula

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Loizeau Valerie; Phone Number: 0139274727; Email: vloizeau@chi-poissy-st-germain.fr

Study Locations

• France
  • Poissy, France
    • Recruiting
    • CH Poissy st Germain
    • Contact: Loizeau Valerie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: puncture bevel up	Device: 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.
Other: puncture bevel domn	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compression time required for hemostasis	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.	period of 3 weeks

Collaborators and Investigators

• Sponsor: Poissy-Saint Germain Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2017
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: TECHFAVHEMO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No