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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03355508
Enrollment
42
Registered
2017-11-28
Start date
2017-09-29
Completion date
2021-02-28
Last updated
2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterio-venous Fistula, Puncture, Chronic Desease

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.

Interventions

DEVICEpucture 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.

Sponsors

Poissy-Saint Germain Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Compression time required for hemostasisperiod of 3 weeksThe 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.

Countries

France

Contacts

Primary ContactLoizeau Valerie
vloizeau@chi-poissy-st-germain.fr0139274727

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026