Clinical trial NCT01536548: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Kidney Failure
Keywords: hemodialysis
cannulation
AV-fistula
buttonhole technique
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Haukeland University Hospital
name: Vestre Viken Hospital Trust
name: Sykehuset Innlandet HF
name: Kristiansund Hospital
name: Bodø sykehus
name: University Hospital, Akershus
First posted: 2012-02-22
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of successful cannulations
timeFrame: 8 weeks
Secondary outcomes:
measure: Difficulty of cannulation
timeFrame: 8 weeks
measure: Fear of cannulation
timeFrame: 8 weeks
measure: Pain at cannulation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Bodø
country: Norway
facility: Bodø Sykehus
city: Drammen
country: Norway
facility: Vestre Viken Sykehus
city: Kristiansund
country: Norway
facility: Kristiansund Sykehus
city: Lillehammer
country: Norway
facility: Sykehuset Innlandet
city: Orkanger
country: Norway
facility: St Olavs Hospital
city: Oslo
country: Norway
facility: Akershus Universitetssykehus
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Stein Hallan, PhD MD
role: STUDY_DIRECTOR
References:
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
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.