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

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ClinicalTrials.gov Identifier: NCT01536548
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : February 13, 2017
Sponsor:
Collaborators:
St. Olavs Hospital
Haukeland University Hospital
Vestre Viken Hospital Trust
Sykehuset Innlandet HF
Kristiansund Hospital
Bodø sykehus
University Hospital, Akershus
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Kidney Failure Procedure: Skin drawing Procedure: No skin drawing Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Hospital Trust
Sykehuset Innlandet HF
Kristiansund Hospital
Bodø sykehus
University Hospital, Akershus
Investigators
Study Director: Stein Hallan, PhD MD Norwegian University of Science and Technology

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01536548     History of Changes
Other Study ID Numbers: 2011/2544
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017

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

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