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The incidence of central line associated infections and inflammation in patients who are self- managing a central line at home: A pilot feasibility study

The incidence of central line associated infections and inflammation in patients who are self- managing a central line at home: A pilot feasibility study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001303437
Enrollment
20
Registered
2025-11-21
Start date
2025-11-24
Completion date
2026-01-01
Last updated
2025-12-01

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

Conditions

None listed

Brief summary

The aim of the study is to prove that there is no greater risk of infection or inflammation to the patient when the patient, who has successfully completed the competency, self exchanges an antibiotic infuser compared with a nurse completing the same procedure. When this hypothesis has been proven then the local health district will be looking at amending procedure in community to accommodate community patients to avoid presenting to emergency departments or delay discharge from hospital due to antibiotic intravenous treatment.

Interventions

The patient will require to successfully complete a competency assessment that focus on strict aseptic technique, safe exchange of a antibiotic infuser without risk of contamination and air embolism. This is achieved by allowing the patient to visualize procedure, then allowed to complete procedure under guidance from an RN. The patient will be provided with a how to guide, a checklist of equipment and a visual guide to every step of the procedure. The patient will complete the procedure once a

The patient will require to successfully complete a competency assessment that focus on strict aseptic technique, safe exchange of a antibiotic infuser without risk of contamination and air embolism. This is achieved by allowing the patient to visualize procedure, then allowed to complete procedure under guidance from an RN. The patient will be provided with a how to guide, a checklist of equipment and a visual guide to every step of the procedure. The patient will complete the procedure once a day, 5 days a week. The procedure from start to finish will take approx 30 min. The patient will do this until the completion of treatment or withdrawal of participation. There is a clinician competency but no consumer competency this has been designed specifically for the study. The non-randomized selection will be alternate between intervention group and control group in a controlled order to allow for equal participants in each group. Daily intervention for patient in the interventiongroup will include: antibiotic infuser change, set of selected vital signs (BP, HR, pain, Temp, Wellbeing) that is entered in to an app by the patient along with pictures take of the IV site and infuser bottle. A non-randomized allocation, in format of A-B-A-B allocation. to alternate between intervention group and control group in a controlled order to allow for equal participants in each group.

Sponsors

Central Coast Health @ Home, Gosford Hospital, Central Coast Local Health District
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Inclusion criteria · Over 18 years. · Ability to provide informed, written consent. · Central venous access device: Peripheral Inserted Central Catheter, Porta Cath, midline, tunneled or non-tunneled line in situ. · Resident of Central Coast Local Health District with a fixed address. · Have a clutter free and clean environment or dedicated space to conduct the procedure. · Hemodynamically stable. · Ability to escalate any clinical concerns according to study protocol. · Have an appointed and trained carer to carry out procedure. · Antimicrobial therapy: Daily intravenous antibiotic changes via an elastomeric device for more than four-week duration. · Ability to utilise smartphone/device to complete daily virtual questionnaire. · Medically appropriate for the study- in consultation with HITH Medical Officer.

Exclusion criteria

Exclusion criteria · Inability to provide informed written consent. · Inability to comprehend procedure, this being due to cognitive reasons or not understanding English information and training provided. · Medical team deeming inappropriate for study and/or procedure. · Previous or current intravenous drug use. · Inability to comply with study protocol. · Requirement of Total Parental Nutrition. · Central venous access device used for dialysis. · BD dosing or IVAB requirement of less than four weeks. · Pregnant patient

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026