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临床试验/NCT07567456
NCT07567456招募中不适用

Exploring the Effectiveness of Pulsatile Flushing Technique in Reducing Blockage of the Tunnelled Central Venous Access Device Among Haemodialysis Patients in Multiple Renal Centres in Hong Kong: A Cluster Non-Randomised Controlled Trial Study

Queen Elizabeth Hospital, Hong Kong1 个研究点 分布在 1 个国家目标入组 591 人开始时间: 2026年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
591
试验地点
1

研究概览

简要总结

This study investigates the effectiveness of pulsatile flushing techniques in reducing blockage in Tunnelled Central Venous Access Device (T-CVAD) among patients undergoing haemodialysis (HD) treatment at multiple renal centres within the Hospital Authority (HA) in Hong Kong. With limitation in single service protocol for each cluster of renal units, it is designed as a prospective, parallel, cluster non-randomised controlled trial involving 591 patients from 14 renal units. In order to identify the most effective flushing technique for T-CVAD maintenance, survival analysis on clinical effectiveness, in terms time-to-event blockage of the T-CVAD, among three trial arms: 1) Intervention Group A (IG-A) using pulsatile flushing technique with 0.4 second pause time interval; 2) Intervention Group B (IG-B) using pulsatile flushing technique with 1 second pause time interval; 3) Control Group (Con) using standard bolus flushing technique. The findings facilitate development of best practice for T-CVAD maintenance, optimise T-CVAD maintenance protocols, and ultimately improve patient outcomes. This groundbreaking study is expected to signify substantial progression in the nursing management of HD and T-CVAD.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing HD treatment with Tunnelled Central Venous Access Device (T-CVAD) in the above collaborators under the Hospital Authority
  • Able to understand spoken and written Chinese or English

排除标准

  • Patients with Non-Tunnelled Central Venous Access Device (NT-CVAD)
  • Temporary dysfunction (e.g., kicking of the catheter) resolved with repositioning
  • Confirmed case of fibrin sheath occlusion which can only be resolved through surgical intervention
  • Non-thrombotic occlusion due to mechanical causes (e.g., catheter malposition)
  • Patient declined or incompetent to provide written informed consent.

研究组 & 干预措施

Intervention Group A

Experimental

Use of pulsatile flushing technique (0.4s pause interval)

干预措施: Pulsatile Flushing Technique (0.4s pause interval) (Device)

Intervention Group B

Experimental

Use of pulsatile flushing technique (1s pause interval)

干预措施: Pulsatile Flushing Technique (1s pause interval) (Other)

Control Group

Active Comparator

Standard bolus flushing technique

干预措施: Bolus Flushing Technique (Device)

研究者

发起方
Queen Elizabeth Hospital, Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

SUNG Ka Ming Dorothy

Nurse Consultant (Renal Care)

Queen Elizabeth Hospital, Hong Kong

研究点 (1)

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