Blockage of Tunnelled Central Venous Access Device, Haemodialysis Patients, Pulsatile Flushing Technique
Conditions
Keywords
HD, T-CVAD, Pulsatile Flushing Technique
Brief summary
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.
Interventions
DEVICEPulsatile Flushing Technique (0.4s pause interval)
Pulsatile flushing technique consists of multiple small boluses injected intermittently with 0.4-second pauses between each bolus resulting in unsteady turbulent flow, performed by a renal nurse who passed a formal train-the-trainer program on "pulsatile flushing technique" taught and assessed by designated nurse consultant (renal care).
OTHERPulsatile Flushing Technique (1s pause interval)
Pulsatile flushing technique consists of multiple small boluses injected intermittently with 1-second pauses between each bolus resulting in unsteady turbulent flow, performed by a renal nurse who passed a formal train-the-trainer program on "pulsatile flushing technique" taught and assessed by designated nurse consultant (renal care).
DEVICEBolus Flushing Technique
Bolus flushing technique involves the continuous administration of a single, concentrated volume of flush solution resulting in consistent laminar flow
Sponsors
Queen Elizabeth Hospital, Hong Kong
Kwong Wah Hospital
Prince of Wales Hospital, Shatin, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
North District Hospital, Hong Kong
Caritas Medical Centre, Hong Kong
Queen Mary Hospital, Hong Kong
Tseung Kwan O Hospital, Hong Kong
Tin Shui Wai Hospital
Yan Chai Hospital
Tung Wah Hospital
Pamela Youde Nethersole Eastern Hospital
Tuen Mun Hospital
Princess Margaret Hospital, Hong Kong
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Paralleled Cluster Non-Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-event T-CVAD Blockage | From the date of recruitment until the end of the study (at least 1-year follow-up) or date of termination (e.g., blockage, death, refusal to participate in the study… etc) whichever comes earlier, assessed up to 24 months. | as measured by time to the first occurrence of blockage of Tunnelled Central Venous Access Device (T-CVAD). T-CVAD blockage episodes can be transformed to incidence rates (in episodes per patient-year), or presented by Kaplan-Meier analysis with median blockage-free survival statistics stratified by three trial arms. |
Countries
Hong Kong
Contacts
CONTACTSUNG Ka Ming Dorothy, KCC NC (Renal Care)
Outcome results
None listed