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

Primary Purpose

Arterio-venous Fistula, Puncture, Chronic Desease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pucture in the arteriovenous fistula
Sponsored by
Poissy-Saint Germain Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arterio-venous Fistula, Puncture, Chronic Desease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CH Poissy st GermainRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

puncture bevel up

puncture bevel domn

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2017
Last Updated
November 21, 2017
Sponsor
Poissy-Saint Germain Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03355508
Brief Title
Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver
Official Title
Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poissy-Saint Germain Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterio-venous Fistula, Puncture, Chronic Desease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
puncture bevel up
Arm Type
Other
Arm Title
puncture bevel domn
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
pucture in the arteriovenous fistula
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compression time required for hemostasis
Description
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.
Time Frame
period of 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loizeau Valerie
Phone
0139274727
Email
vloizeau@chi-poissy-st-germain.fr
Facility Information:
Facility Name
CH Poissy st Germain
City
Poissy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loizeau Valerie

12. IPD Sharing Statement

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

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