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

Sponsor

Fresenius Medical Care Deutschland GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05081648

Collaborator

University of Lisbon (Other), Lisbon Nursing School (Other)

200

Enrollment

Locations

Arms

20.9

Anticipated Duration (Months)

66.7

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Hemodialysis Vascular Access Complication Hemodialysis Access Failure Arteriovenous Fistula	Procedure: CT MuST Procedure: Rope-ladder cannulation technique	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

multiple-center, prospective, non-blind, parallel-group, randomized controlledmultiple-center, prospective, non-blind, parallel-group, randomized controlled

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 3, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group: Multiple Single Cannulation Technique (MuST)	Procedure: CT MuST Multiple Single Cannulation Technique (MuST): Experimental technique
Other: Control group: Rope-ladder cannulation technique (RL)	Procedure: Rope-ladder cannulation technique Standard cannulation technique( Rope-ladder)

Arm

Intervention/Treatment

Experimental: Intervention group: Multiple Single Cannulation Technique (MuST)

Procedure: CT MuST

Multiple Single Cannulation Technique (MuST): Experimental technique

Other: Control group: Rope-ladder cannulation technique (RL)

Procedure: Rope-ladder cannulation technique

Standard cannulation technique( Rope-ladder)

Outcome Measures

Primary Outcome Measures

Vascular access survival rate [12 months after start of study]
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".

Secondary Outcome Measures

Arteriovenous fistula survival rate [12 months after start of study]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.