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

NCT ID: NCT05081648

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Diseases Hemodialysis Vascular Access Complication Hemodialysis Access Failure Arteriovenous Fistula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

multiple-center, prospective, non-blind, parallel-group, randomized controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group: Multiple Single Cannulation Technique (MuST)

Group Type EXPERIMENTAL

CT MuST

Intervention Type PROCEDURE

Multiple Single Cannulation Technique (MuST): Experimental technique

Control group: Rope-ladder cannulation technique (RL)

Group Type OTHER

Rope-ladder cannulation technique

Intervention Type PROCEDURE

Standard cannulation technique( Rope-ladder)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CT MuST

Multiple Single Cannulation Technique (MuST): Experimental technique

Intervention Type PROCEDURE

Rope-ladder cannulation technique

Standard cannulation technique( Rope-ladder)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Lisbon

OTHER

Sponsor Role collaborator

Lisbon School of Nursing

UNKNOWN

Sponsor Role collaborator

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NephroCare Coimbra

Coimbra, , Portugal

Site Status

Nephrocare Montijo

Montijo, , Portugal

Site Status

NephroCare Vila Nova de Gaia

Vila Nova de Gaia, , Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35729492 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HD-MuST-01-PT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.