Arterio-venous Fistula, Puncture, Chronic Desease Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 42 |
| Est. completion date | February 2021 |
| Est. primary completion date | September 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | CH Poissy st Germain | Poissy |
| Lead Sponsor | Collaborator |
|---|---|
| Poissy-Saint Germain Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |