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Effect of Bevel Position of the Artery Needle on Puncture Pain and Post-puncture Bleeding Time

NCT ID: NCT05115448

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-05-01

Brief Summary

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A patient with an arteriovenous fistula (AVF) receiving chronic hemodialysis (HD) treatment is cannulated 312 times a year on average. The patients cannot comply with dialysis treatment and the quality of life is decreased by pain when the fistula cannot be accessed with a single attempt. Sharp pain depends on the tear in the skin, the tissue where the sensitive nerve ends receptive to pain are located, and it is particularly important during AVF puncture. Also, punctures are accompanied by haemorrhages and frequent loss of blood.

Detailed Description

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The repeated puncture of the AVF leads to a considerable degree of pain, due to the calibre and length of the bevel of fistula needles. When the fistula needle is removed, the small punctures that occur in the entrance area are closed with a thrombus. As a result, scar tissue forms in the entrance area and the surrounding skin, which can lead to the development of stenosis and aneurysm. For this reason, the needle conical tip direction is important in terms of delaying the loss of tissue elasticity and prolonging the use of the intervention area. There are very few studies investigating the effect of the conical tip being up or down on the pain that develops during cannulation in the patient.

Conditions

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Pain Bleeding Time Arteriovenous Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Bevel Up

In the patients who participated in the study, cannulation was applied to the fistula with the needle direction antegrade and the needle pointing upwards for the first 6 sessions, and the needle direction antegrade and the needle tip facing down for the next 6 sessions. The cannulation procedure was performed by the same nurse for each patient who participated in the study.

Group Type OTHER

Bevel Position

Intervention Type OTHER

During 6 dialysis sessions, cannulation was applied to the patients with the direction of the arterial needle in the antegrade direction and the conical tip facing upwards. In the next 6 dialysis sessions, cannulation was applied to the patients in an antegrade direction and with the conical tip facing down.

Bevel Down

In the patients who participated in the study, cannulation was applied to the fistula with the needle direction antegrade and the needle pointing downwards for the next 6 sessions. The cannulation procedure was performed by the same nurse for each patient who participated in the study.

Group Type OTHER

Bevel Position

Intervention Type OTHER

During 6 dialysis sessions, cannulation was applied to the patients with the direction of the arterial needle in the antegrade direction and the conical tip facing upwards. In the next 6 dialysis sessions, cannulation was applied to the patients in an antegrade direction and with the conical tip facing down.

Interventions

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Bevel Position

During 6 dialysis sessions, cannulation was applied to the patients with the direction of the arterial needle in the antegrade direction and the conical tip facing upwards. In the next 6 dialysis sessions, cannulation was applied to the patients in an antegrade direction and with the conical tip facing down.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* On maintenance hemodialysis three times per week for four hours per session
* Receiving hemodialysis therapy for a least six moths at the time of the study
* Pain level of one or more measured by the Visual Analogue Scale during cannulation
* Able to communicate in Turkish
* Willing to participate to the study

Exclusion Criteria

* Known to be difficult to enter the fistula (with more than one cannulation)
* History of hematoma or stenosis in fistula
* Having an infection in the fistula area
* Taking painkillers 3 hours before treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Demiroglu Bilim University

OTHER

Sponsor Role lead

Responsible Party

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Nurten Ozen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Demiroglu Bilim University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Crespo Montero R, Rivero Arellano F, Contreras Abad MD, Martinez Gomez A, Fuentes Galan MI. Pain degree and skin damage during arterio-venous fistula puncture. EDTNA ERCA J. 2004 Oct-Dec;30(4):208-12. doi: 10.1111/j.1755-6686.2004.tb00369.x.

Reference Type BACKGROUND
PMID: 15835412 (View on PubMed)

Gaspar LJ, Moreira NM, Moutinho AA, Pinto PJ, Lima HB, Rodrigues F. Puncture of the arteriovenous fistula: bevel upward or bevel downward? EDTNA ERCA J. 2003 Apr-Jun;29(2):104. doi: 10.1111/j.1755-6686.2003.tb00284.x. No abstract available.

Reference Type BACKGROUND
PMID: 14598956 (View on PubMed)

Marticorena RM, Donnelly SM. Impact of needles in vascular access for hemodialysis. J Vasc Access. 2016 Mar;17 Suppl 1:S32-7. doi: 10.5301/jva.5000534. Epub 2016 Mar 6.

Reference Type BACKGROUND
PMID: 26951901 (View on PubMed)

Other Identifiers

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07/16/2019

Identifier Type: -

Identifier Source: org_study_id