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Central venous Access device SeCurement And Dressing Effectiveness (CASCADE) in paediatrics: protocol for pilot
Amanda J Ullman1, Tricia Kleidon2, Victoria Gibson3
1School of Nursing and Midwifery, Griffith University, Nathan, Queensland, Australia NHMRC Centre of Research Excellence in Nursing, Menzies Health Institute Queensland, Nathan, Queensland, Australia Alliance for Vascular Access Teaching and Research Group, Menzies Health Institute Queensland, Nathan, Queensland, Australia.
Insights
This study assesses the feasibility of a large trial on paediatric central venous access device (CVAD) securement and dressing methods. Findings will inform future efficacy trials for reducing CVAD failure and complications in children.
Area of Science:
- Pediatric medical devices
- Clinical trial methodology
- Infection control in healthcare
Background:
- Paediatric central venous access devices (CVADs) have a high failure rate (25%).
- Current securement and dressing methods may not be optimal.
- Innovative technologies require evaluation for effectiveness across different CVAD types.
Purpose of the Study:
- To evaluate the feasibility of a full-scale randomised controlled efficacy trial.
- To assess CVAD securement and dressing strategies in paediatric patients.
- To establish criteria for launching a definitive efficacy trial.
Main Methods:
- Three feasibility randomised controlled trials at two Australian hospitals.
- Comparison of current practice with sutureless securement, integrated dressings, and tissue adhesive.
- Recruitment of 328 paediatric patients across three CVAD types: PICC, non-tunnelled CVAD, and tunnelled CVAD.
Main Results:
- Primary outcomes focus on study feasibility: eligibility, recruitment, retention, attrition, data completeness, and satisfaction.
- Secondary outcomes include CVAD failure and complication rates (infections, thrombosis, occlusion, dislodgement, breakage).
- Effect sizes will be calculated to inform sample size for future efficacy trials.
Conclusions:
- This research provides crucial feasibility data for a large-scale trial on paediatric CVAD management.
- Findings will guide the selection of optimal securement and dressing strategies.
- The study aims to reduce CVAD failure and associated complications in children.
Introduction:
Paediatric central venous access devices (CVADs) are associated with a 25% incidence of failure. Securement and dressing are strategies used to reduce failure and complication; however, innovative technologies have not been evaluated for their effectiveness across device types. The primary aim of this research is to evaluate the feasibility of launching a full-scale randomised controlled efficacy trial across three CVAD types regarding CVAD securement and dressing, using predefined feasibility criteria.
Methods And Analysis:
Three feasibility randomised, controlled trials are to be undertaken at the Royal Children's Hospital and the Lady Cilento Children's Hospital, Brisbane, Australia. CVAD securement and dressing interventions under examination compare current practice with sutureless securement devices, integrated securement dressings and tissue adhesive. In total, 328 paediatric patients requiring a peripherally inserted central catheter (n=100); non-tunnelled CVAD (n=180) and tunnelled CVAD (n=48) to be inserted will be recruited and randomly allocated to CVAD securement and dressing products. Primary outcomes will be study feasibility measured by eligibility, recruitment, retention, attrition, missing data, parent/staff satisfaction and effect size. CVAD failure and complication (catheter-associated bloodstream infection, local infection, venous thrombosis, occlusion, dislodgement and breakage) will be compared between groups.
Ethics And Dissemination:
Ethical approval to conduct the research has been obtained. All dissemination will be undertaken using the CONSORT Statement recommendations. Additionally, the results will be sent to the relevant organisations which lead CVAD focused clinical practice guidelines development.
Trial Registration Numbers:
ACTRN12614001327673; ACTRN12615000977572; ACTRN12614000280606.
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