Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: Contributions for a Safe Nursing Intervention

Study Overview
=================
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).

Official Title
-----------------
A Randomised Control Trial of MuST Technique for Vascular Access Cannulation in Hemodialysis Patients: Contributions for a Safe Nursing Intervention

Conditions
-----------------
Chronic Kidney Diseases, Hemodialysis, Vascular Access Complication, Hemodialysis Access Failure, Arteriovenous Fistula

Intervention / Treatment
-----------------
* Procedure: CT MuST
* Procedure: Rope-ladder cannulation technique


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multiple-center, prospective, non-blind, parallel-group, randomized controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group: Multiple Single Cannulation Technique (MuST)<br> | Procedure: CT MuST<br>* Multiple Single Cannulation Technique (MuST): Experimental technique<br>|
| Other: Control group: Rope-ladder cannulation technique (RL)<br> | Procedure: Rope-ladder cannulation technique<br>* Standard cannulation technique( Rope-ladder)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular access survival rate | Vascular access (VA) survival rate at 12 months and determined by the percentage of fistulas in use from the beginning of the study to the date of the first clinical intervention by angioplasty or vascular surgery, to maintain or restore patency - unassisted patency. | 12 months after start of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arteriovenous fistula survival rate | Arteriovenous fistula (AVF) survival rate at 12-month and determined by the percentage of fistulas in use from the study start to the date of access abandonment due to dysfunction, patient abandonment, or death, treatment change modality or study end. | 12 months after start of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Hemodialysis, Vascular access, Vascular Access Complication, Rope-ladder, Cannulation