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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536548
• Other study ID #: 2011/2544
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: September 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Chronic Kidney Disease
• Fistula
• Kidney Diseases
• Kidney Failure
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Procedure:
• Skin drawing
Mark direction and angle for cannulation with a pencil on the skin
• No skin drawing
Standard practice; i.e. no marks on skin to help find correct direction and angle for introducing needles

Locations

Country	Name	City	State
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

Sponsors (8)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Bodø sykehus, Haukeland University Hospital, Kristiansund Hospital, St. Olavs Hospital, Sykehuset Innlandet HF, University Hospital, Akershus, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of successful cannulations	A successful cannulation is defined as being able to insert a blunt needle in both canals at the first attempt.	8 weeks
Secondary	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.	8 weeks
Secondary	Fear of cannulation	Patients describe on a Verbal Rating Scale (0-10) how strongly they fear the cannulation. Assessed once a week.	8 weeks
Secondary	Pain at cannulation	Patients describe on a VAS scale (0-10) how painful the cannulation was experienced. Assessed once a week.	8 weeks