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

Not Applicable

Completed

• Conditions: Hemodialysis; Chronic Kidney Diseases; Hemodialysis Access Failure; Vascular Access Complication; Arteriovenous Fistula
• Interventions: Procedure: CT MuST; Procedure: Rope-ladder cannulation technique

• Registration Number: NCT05081648
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

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).

Study Timeline

• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-18
• Study Start: 2022-01-03
• Primary Completion: 2022-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group: Multiple Single Cannulation Technique (MuST)	CT MuST	-
Control group: Rope-ladder cannulation technique (RL)	Rope-ladder cannulation technique	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (3)

Nephrocare Montijo; 🇵🇹 Montijo, Portugal

NephroCare Coimbra; 🇵🇹 Coimbra, Portugal

NephroCare Vila Nova de Gaia; 🇵🇹 Vila Nova De Gaia, Portugal