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Completed

NCT Number: NCT05081648

Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: 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.

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Key information

Conditions

Chronic Kidney Diseases Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Hemodialysis Hemodialysis Access Failure Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Access Complication Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NephroCare Coimbra, Coimbra, Portugal

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CT MuST

Procedure

Multiple Single Cannulation Technique (MuST): Experimental technique

Rope-ladder cannulation technique

Procedure

Standard cannulation technique( Rope-ladder)

Primary outcomes

  1. Vascular access survival rate

    Time frame: 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 outcomes

  1. Arteriovenous fistula survival rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Collaborators

  • Lisbon School of Nursing
  • University of Lisbon

Registry information

Official study title

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

Acronym: MuST

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 18, 2021
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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