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



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.



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.



ACTRN12614001327673; ACTRN12615000977572; ACTRN12614000280606.
School 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.
Amanda J
0000-0001-8860-5319
AJ
Ullman
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 Children's Health Queensland, Lady Cilento Children's Hospital, South Brisbane, Queensland, Australia.
Tricia
0000-0001-8369-3970
T
Kleidon
Alliance for Vascular Access Teaching and Research Group, Menzies Health Institute Queensland, Nathan, Queensland, Australia Children's Health Queensland, Lady Cilento Children's Hospital, South Brisbane, Queensland, Australia.
Victoria
V
Gibson
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 Children's Health Queensland, Lady Cilento Children's Hospital, South Brisbane, Queensland, Australia.
Debbie A
DA
Long
Alliance for Vascular Access Teaching and Research Group, Menzies Health Institute Queensland, Nathan, Queensland, Australia Children's Health Queensland, Lady Cilento Children's Hospital, South Brisbane, Queensland, Australia.
Tara
T
Williams
Alliance for Vascular Access Teaching and Research Group, Menzies Health Institute Queensland, Nathan, Queensland, Australia Children's Health Queensland, Lady Cilento Children's Hospital, South Brisbane, Queensland, Australia School of Medicine, University of Queensland, Herston, Queensland, Australia.
Craig A
0000-0001-8377-1748
CA
McBride
Alliance for Vascular Access Teaching and Research Group, Menzies Health Institute Queensland, Nathan, Queensland, Australia Children's Health Queensland, Lady Cilento Children's Hospital, South Brisbane, Queensland, Australia School of Medicine, University of Queensland, Herston, Queensland, Australia.
Andrew
A
Hallahan
Alliance for Vascular Access Teaching and Research Group, Menzies Health Institute Queensland, Nathan, Queensland, Australia School of Medicine, Griffith University, Brisbane, Queensland, Australia Centre for Applied Health Economics, Menzies Health Institute Queensland, Nathan, Queensland, Australia.
Gabor
G
Mihala
School 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.
Marie
M
Cooke
School 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.
Claire M
CM
Rickard
D001315:Australia / Q000453:epidemiology; D001458:Bandages; D055499:Catheter-Related Infections / Q000453:epidemiology* / Q000517:prevention & control; D002405:Catheterization, Central Venous / Q000009:adverse effects / Q000379:methods*; D002408:Catheters, Indwelling / Q000009:adverse effects; D062905:Central Venous Catheters; D002648:Child; D002985:Clinical Protocols; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005240:Feasibility Studies; D005260:Female; D006776:Hospitals, Pediatric; D006801:Humans; D015994:Incidence; D008297:Male; D010865:Pilot Projects; D011140:Polyurethanes; D016896:Treatment Outcome
D011140:Polyurethanes
central venous catheter; dressing; evidence-based practice; protocol; site care