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

摘要

Introduction: Paediatric central venous access devices(CVADs) are associated with a 25% incidence offailure. Securement and dressing are strategies used toreduce failure and complication; however, innovativetechnologies have not been evaluated for theireffectiveness across device types. The primary aim ofthis research is to evaluate the feasibility of launching afull-scale randomised controlled efficacy trial acrossthree CVAD types regarding CVAD securement anddressing, using predefined feasibility criteria.Methods and analysis: Three feasibility randomised,controlled trials are to be undertaken at the RoyalChildren’s Hospital and the Lady Cilento Children’sHospital, Brisbane, Australia. CVAD securement anddressing interventions under examination comparecurrent practice with sutureless securement devices,integrated securement dressings and tissue adhesive. Intotal, 328 paediatric patients requiring a peripherallyinserted central catheter (n=100); non-tunnelled CVAD(n=180) and tunnelled CVAD (n=48) to be inserted will berecruited and randomly allocated to CVAD securementand dressing products. Primary outcomes will be studyfeasibility measured by eligibility, recruitment, retention,attrition, missing data, parent/staff satisfaction and effectsize. CVAD failure and complication (catheter-associatedbloodstream infection, local infection, venousthrombosis, occlusion, dislodgement and breakage) willbe compared between groups.Ethics and dissemination: Ethical approval to conductthe research has been obtained. All dissemination will beundertaken using the CONSORT Statementrecommendations. Additionally, the results will be sent tothe relevant organisations which lead CVAD focusedclinical practice guidelines development.