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

Primary Purpose

Chronic Kidney Disease, Kidney Failure

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Skin drawing
No skin drawing
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring hemodialysis, cannulation, AV-fistula, buttonhole technique

Eligibility Criteria

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

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

Sites / Locations

  • Haukeland Universitetssykehus
  • Bodø Sykehus
  • Vestre Viken Sykehus
  • Kristiansund Sykehus
  • Sykehuset Innlandet
  • St Olavs Hospital
  • Akershus Universitetssykehus
  • St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Skin drawing

No skin drawing

Arm Description

Outcomes

Primary Outcome Measures

Percentage of successful cannulations
A successful cannulation is defined as being able to insert a blunt needle in both canals at the first attempt.

Secondary Outcome Measures

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

Full Information

First Posted
February 16, 2012
Last Updated
September 30, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Haukeland University Hospital, Vestre Viken Hospital Trust, Sykehuset Innlandet HF, Kristiansund Hospital, Bodø sykehus, University Hospital, Akershus
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1. Study Identification

Unique Protocol Identification Number
NCT01536548
Brief Title
Indicating Direction and Angle for Cannulating of AV-fistula in Hemodialysis Patients
Official Title
Indicating Direction and Angle for Button-hole Cannulating of AV-fistula in Hemodialysis Patients - a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Haukeland University Hospital, Vestre Viken Hospital Trust, Sykehuset Innlandet HF, Kristiansund Hospital, Bodø sykehus, University Hospital, Akershus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Kidney Failure
Keywords
hemodialysis, cannulation, AV-fistula, buttonhole technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skin drawing
Arm Type
Experimental
Arm Title
No skin drawing
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Skin drawing
Intervention Description
Mark direction and angle for cannulation with a pencil on the skin
Intervention Type
Procedure
Intervention Name(s)
No skin drawing
Intervention Description
Standard practice; i.e. no marks on skin to help find correct direction and angle for introducing needles
Primary Outcome Measure Information:
Title
Percentage of successful cannulations
Description
A successful cannulation is defined as being able to insert a blunt needle in both canals at the first attempt.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Difficulty of cannulation
Description
Nurse and patients describe on a Verbal Rating Scale (1-6) how difficult the cannulation was experienced. All dialysis sessions are scored.
Time Frame
8 weeks
Title
Fear of cannulation
Description
Patients describe on a Verbal Rating Scale (0-10) how strongly they fear the cannulation. Assessed once a week.
Time Frame
8 weeks
Title
Pain at cannulation
Description
Patients describe on a VAS scale (0-10) how painful the cannulation was experienced. Assessed once a week.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stein Hallan, PhD MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland Universitetssykehus
City
Bergen
Country
Norway
Facility Name
Bodø Sykehus
City
Bodø
Country
Norway
Facility Name
Vestre Viken Sykehus
City
Drammen
Country
Norway
Facility Name
Kristiansund Sykehus
City
Kristiansund
Country
Norway
Facility Name
Sykehuset Innlandet
City
Lillehammer
Country
Norway
Facility Name
St Olavs Hospital
City
Orkanger
Country
Norway
Facility Name
Akershus Universitetssykehus
City
Oslo
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
Citation
Rønning MI, Benshop P , Hallan S. Direction and angle-assisted cannulation of AV-fistula in hemodialysis patients - a rancomized controlled study. 2016; Oral presentation for the Vascular Access Society of America, Chicago 2016, abstract 1.1.4.8
Results Reference
background
PubMed Identifier
35243305
Citation
Ronning MI, Benschop WP, Ovrehus MA, Hultstrom M, Hallan SI. Direction- and Angle-Assisted Buttonhole Cannulation of Arteriovenous Fistula in Hemodialysis Patients: A Multicenter Randomized Controlled Trial. Kidney Med. 2021 Dec 1;4(2):100393. doi: 10.1016/j.xkme.2021.10.006. eCollection 2022 Feb.
Results Reference
derived

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

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