Clinical trial NCT05081648: Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: Contributions for a Safe Nursing Intervention
Official title: A Randomised Control Trial of MuST Technique for Vascular Access Cannulation in Hemodialysis Patients: Contributions for a Safe Nursing Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Hemodialysis
Vascular Access Complication
Hemodialysis Access Failure
Arteriovenous Fistula
Keywords: Chronic Kidney Disease
Hemodialysis
Vascular access
Vascular Access Complication
Rope-ladder
Cannulation
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: University of Lisbon
name: Lisbon School of Nursing
First posted: 2021-10-18
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multiple-center, prospective, non-blind, parallel-group, randomized controlled
Primary purpose: TREATMENT

Brief summary: The aims of this study are to:

* Determine the AVF (arteriovenous fistula) survival of patients submitted to MuST compared to those submitted to RL (rope-ladder).
* Determine the AVF (arteriovenous fistula) complication rate of patients submitted to MuST compared to those submitted to RL (rope-ladder).
* Analyze the intensity of pain perceived by the patient with each cannulation technique under study.

Detailed description: The MuST is based on the association between the RL technique in that it uses the entire length of the available vessel through progressive rotation, and the buttonhole (BH) cannulation technique since there are three specific cannulation sites for each cannulation day during the week, meaning that each site is only cannulated once a week (allowing the puncture site to heal in between cannulations).

Eligibility criteria: Inclusion Criteria:

* Voluntarily agree to participate in the study and sign an informed consent;
* Are on a regular haemodialysis (HD) program with three weekly sessions;
* AVF has been in use for at least 4 weeks without incident;
* AVF with blood flow (Qa) ≥500 mL/min evaluated by thermodilution;
* AVF paths allow cannulations along the entire length of the vein with at least 6 cm of distance between bevels, or two distinct areas of 3 cm in length;
* Adult patients

Exclusion Criteria:

* Those who decline to take part;
* Those who have undergone angiography or surgical intervention in the last 4 months in the AVF in use;
* Those who have undergone three or more interventions in the AVF in use;
* Those with use of anesthetic creams at cannulation sites.

Primary outcomes:
measure: Vascular access survival rate
timeFrame: 12 months after start of study
Secondary outcomes:
measure: Arteriovenous fistula survival rate
timeFrame: 12 months after start of study
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: NephroCare Coimbra
city: Montijo
country: Portugal
facility: Nephrocare Montijo
city: Vila Nova De Gaia
country: Portugal
facility: NephroCare Vila Nova de Gaia
Study officials:
References:
citation: Peralta R, Wammi A, Stauss-Gabo M, Dias O, Carvalho H, Cristovao A. A randomised control trial protocol of MuST for vascular access cannulation in hemodialysis patients (MuST Study): contributions for a safe nursing intervention. BMC Nephrol. 2022 Jun 21;23(1):218. doi: 10.1186/s12882-022-02842-3.