Ullman Amanda J, Kleidon Tricia, Gibson Victoria, Long Debbie A, Williams Tara, McBride Craig A, Hallahan Andrew, Mihala Gabor, Cooke Marie, Rickard Claire M
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.
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.
BMJ Open. 2016 Jun 3;6(6):e011197. doi: 10.1136/bmjopen-2016-011197.
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.
儿科中心静脉通路装置（CVADs）的失败发生率为25%。固定和敷料是用于减少失败和并发症的策略；然而，尚未对创新技术在不同类型装置中的有效性进行评估。本研究的主要目的是使用预先定义的可行性标准，评估针对三种CVAD类型开展一项关于CVAD固定和敷料的全面随机对照疗效试验的可行性。
将在澳大利亚布里斯班的皇家儿童医院和西伦托夫人儿童医院进行三项可行性随机对照试验。正在研究的CVAD固定和敷料干预措施将当前做法与无缝合固定装置、一体化固定敷料和组织粘合剂进行比较。总共将招募328名需要插入外周静脉中心导管（n = 100）、非隧道式CVAD（n = 180）和隧道式CVAD（n = 48）的儿科患者，并将其随机分配至CVAD固定和敷料产品组。主要结局将通过合格性、招募、留存、损耗、缺失数据、家长/工作人员满意度和效应大小来衡量研究可行性。将比较各组之间的CVAD失败和并发症（导管相关血流感染、局部感染、静脉血栓形成、堵塞、移位和破损）情况。
已获得开展本研究的伦理批准。所有传播将按照CONSORT声明建议进行。此外，研究结果将发送给负责制定CVAD相关临床实践指南的相关组织。
ACTRN12614001327673；ACTRN12615000977572；ACTRN12614000280606。
