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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Hemodialysis; Hemodialysis Access Failure; Arteriovenous Fistula; Vascular Access Complication
• Intervention / Treatment: Procedure: CT MuST; Procedure: Rope-ladder cannulation technique

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Coimbra, Portugal, 3025-04
    • NephroCare Coimbra
  • Montijo, Portugal, 2870-281
    • Nephrocare Montijo
  • Vila Nova De Gaia, Portugal, 4430-703
    • NephroCare Vila Nova de Gaia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

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

Collaborators and Investigators

• Sponsor: Fresenius Medical Care Deutschland GmbH
• Collaborators: University of Lisbon; Lisbon School of Nursing

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Hemodialysis; Cannulation; Vascular access; Vascular Access Complication; Rope-ladder
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Disease Attributes; Congenital Abnormalities; Renal Insufficiency; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: HD-MuST-01-PT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No