Central venous Access device SeCurement And Dressing Effectiveness (CASCADE) in paediatrics: protocol for pilot...

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.