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

NCT05115448 | Completed

• 1 other identifier: 07/16/2019
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Bleeding Time; Arteriovenous Fistula

Outcome Measures

Primary Outcomes (2)

• Change From Baseline Invasive Pain at 12 Dialysis Session

  It will be assessed three times at the end of the dialysis session with Visual Analogue. Pain intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. Pain increases as the score increases. The high point describes bad outcome.

  At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)

• Change From Baseline Post-Puncture Bleeding at 12 Dialysis Session

  Bleeding time was defined as the time (minutes) from the moment the pressure was applied to the moment when the bleeding stopped after the fistula needle was removed.

  At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)

Study Arms (2)

Bevel Up

OTHER

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.

Other: Bevel Position

Bevel Down

OTHER

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.

Other: Bevel Position

Interventions

Bevel Position 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; Bevel Up

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Demiroglu Bilim University: lead

Study Sites (1)

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 15835412 BACKGROUND

• 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.

  PMID: 14598956 BACKGROUND

• 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.

  PMID: 26951901 BACKGROUND

MeSH Terms

Conditions

Pain; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 10, 2021
• Study Start: February 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)