Indicating Direction and Angle for Cannulating of AV-fistula in Hemodialysis Patients

September 30, 2020 updated by: Norwegian University of Science and Technology

Indicating Direction and Angle for Button-hole Cannulating of AV-fistula in Hemodialysis Patients - a Randomized Controlled Study

Arteriovenous fistula is the preferred access for hemodialysis, and cannulation using a "button-hole" technique is increasingly recommended. By using the same two sites for cannulation there are reports of less risk of complications and less pain for the patient. However, button-hole cannulation can be difficult for the dialysis nurse, and failing cannulations can damage the AV fistula and increase patient discomfort. The investigators therefore will test whether a simple marking on the skin of the direction and angle of cannulation used in each specific patient could improve the probability of a successful and painfree cannulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Haukeland Universitetssykehus
      • Bodø, Norway
        • Bodø Sykehus
      • Drammen, Norway
        • Vestre Viken Sykehus
      • Kristiansund, Norway
        • Kristiansund Sykehus
      • Lillehammer, Norway
        • Sykehuset Innlandet
      • Orkanger, Norway
        • St Olavs Hospital
      • Oslo, Norway
        • Akershus Universitetssykehus
      • Trondheim, Norway
        • St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic kidney disease
  • hemodialysis
  • arteriovenous fistula
  • established buttonhole technique
  • informed consent signed

Exclusion Criteria:

  • child
  • minor
  • not speaking Norwegian
  • not willing to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin drawing
Procedure: Skin drawing
Mark direction and angle for cannulation with a pencil on the skin
Active Comparator: No skin drawing
Procedure: No skin drawing
Standard practice; i.e. no marks on skin to help find correct direction and angle for introducing needles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of successful cannulations
Time Frame: 8 weeks
A successful cannulation is defined as being able to insert a blunt needle in both canals at the first attempt.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficulty of cannulation
Time Frame: 8 weeks
Nurse and patients describe on a Verbal Rating Scale (1-6) how difficult the cannulation was experienced. All dialysis sessions are scored.
8 weeks
Fear of cannulation
Time Frame: 8 weeks
Patients describe on a Verbal Rating Scale (0-10) how strongly they fear the cannulation. Assessed once a week.
8 weeks
Pain at cannulation
Time Frame: 8 weeks
Patients describe on a VAS scale (0-10) how painful the cannulation was experienced. Assessed once a week.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Vestre Viken Hospital Trust
Haukeland University Hospital
St. Olavs Hospital
Sykehuset Innlandet HF
University Hospital, Akershus
Kristiansund Hospital
Bodø sykehus

Investigators

  • Study Director: Stein Hallan, PhD MD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (Estimate)

February 22, 2012

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/2544

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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