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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. Olavs Hospital
Haukeland University Hospital
Vestre Viken HF Drammen Hospital
Sykehuset Innlandet HF Lillehammer Hospital
Kristiansund sykehus
Bodø sykehus
University Hospital, Akershus
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01536548
First received: February 16, 2012
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Kidney Failure
 Procedure: Skin drawing
Procedure: No skin drawing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Indicating Direction and Angle for Button-hole Cannulating of AV-fistula in Hemodialysis Patients - a Randomized Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Percentage of successful cannulations [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Patients describe on a Verbal Rating Scale (0-10) how strongly they fear the cannulation. Assessed once a week.

  • Pain at cannulation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Patients describe on a VAS scale (0-10) how painful the cannulation was experienced. Assessed once a week.


Enrollment: 83
Study Start Date: March 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536548

Locations
Norway
Haukeland Universitetssykehus
Bergen, Norway
Bodø Sykehus
Bodø, Norway
Vestre Viken Sykehus
Drammen, Norway
Kristiansund Sykehus
Kristiansund, Norway
Sykehuset Innlandet
Lillehammer, Norway
St Olavs Hospital
Orkanger, Norway
Akershus Universitetssykehus
Oslo, Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Haukeland University Hospital
Vestre Viken HF Drammen Hospital
Sykehuset Innlandet HF Lillehammer Hospital
Kristiansund sykehus
Bodø sykehus
University Hospital, Akershus
Investigators
Study Director: Stein Hallan, PhD MD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01536548     History of Changes
Other Study ID Numbers: 2011/2544
Study First Received: February 16, 2012
Last Updated: March 29, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
hemodialysis
cannulation
AV-fistula
buttonhole technique

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Arteriovenous Malformations
Vascular Malformations
 Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013