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Comparison of plastic fistula cannulae versus metal fistula needles in haemodialysis in-centre patients

Comparison of plastic fistula cannulae versus metal fistula needles in haemodialysis incentre patients in terms of number of cannulation failures, intra-dialytic infiltrations and needlestick injuries along with staff and patient satisfaction.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000937617
Enrollment
60
Registered
2014-09-02
Start date
2014-10-28
Completion date
2014-11-05
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Comparison of plastic cannulae and metal fistula needles. The different outcomes associated with the use of plastic fistula cannulae compared with metal fistula needles will be investigated in haemodialysis in-centre patients.

Interventions

The trial duration is four, one month treatment blocks. Each treatment block will be comprised of a one month period using either metal or plastic cannulisation devices. The double crossover design should allow for any bias attributable to unfamiliarity with the test needles. The design will also allow us to assess for any learner effect with using the new plastic cannulae. Subjects will be randomly allocated to one of four treatment sequences, so that we can assess for treatment order effect

The trial duration is four, one month treatment blocks. Each treatment block will be comprised of a one month period using either metal or plastic cannulisation devices. The double crossover design should allow for any bias attributable to unfamiliarity with the test needles. The design will also allow us to assess for any learner effect with using the new plastic cannulae. Subjects will be randomly allocated to one of four treatment sequences, so that we can assess for treatment order effect. Each patient will use both devices equally over the four month period. They will be randomised into four different arms of the trial consisting of four different regimens. The four different regimens will be one month blocks consisting of the use of the devices for every dialysis session during that month as followed; 1) Plastic, Metal, Plastic, Metal 2) Metal, Plastic, Plastic, Metal 3) Plastic, Metal, Metal, Plastic 4) Metal, Plastic, Metal, Plastic There will be no washout period but the crossover design is to minimise bias as much as possible. Each patient will have the device they are required to be using for the month in adherance to the trial protocol, clearly labelled on their care path.

Sponsors

Logan Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients on haemodialysis at Logan Hospital dialysing via an arteriovenous fistulae or an arterovenous graft.

Exclusion criteria

Patients not willing to consent, patients unable to consent due to cognitive decline or unstable mental illness, patients less than 18 years of age, patients who are highly self-caring and insert their own needles.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026