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

NCT03355508 | Unknown

• 1 other identifier: TECHFAVHEMO
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterio-venous Fistula, Puncture, Chronic Desease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

puncture bevel up

OTHER

Device: pucture in the arteriovenous fistula

puncture bevel domn

OTHER

Device: pucture in the arteriovenous fistula

Interventions

pucture in the arteriovenous fistula 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; puncture bevel up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poissy-Saint Germain Hospital: lead

Study Sites (1)

CH Poissy st Germain

Poissy, France

RECRUITING

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Loizeau Valerie

CONTACT

0139274727; vloizeau@chi-poissy-st-germain.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 28, 2017
• Study Start: September 29, 2017
• Primary Completion: September 1, 2020
• Study Completion: February 1, 2021
• Last Updated: November 28, 2017

Record last verified: 2017-10

Locations

FR (1)