None listed
Conditions
Brief summary
Despite the importance of PIVCs to the delivery of patient care, failure and complication rates are unacceptably high. Rates of failure and unscheduled reinsertions due to complications are reported to be between 30 and 69%. Factors responsible for early failure include phlebitis, occlusion, infiltration, extravasation, dislodgement and infection. PIVC failure is a significant cost to both patients and the health care system. Effective securement of PIVC is paramount to preventing failure and complications however, to date, an optimal dressing and securement combination is yet to be identified and more innovative solutions are required. An evidence gap exists regarding the use of medical adhesive tapes and supplementary securement products in PIVC care. We will conduct a single centre pilot randomised controlled trial (RCT) to assess the feasibility of conducting a large scale RCT testing PIVC securement bundles against standard care to prevent PIVC failure and complications. The primary aim of this study is to establish feasibility of the protocol and the planned processes. This will help to budget and plan correctly for the larger definitive trial. We will collect data on the success of screening and recruitment strategies; test our data collection processes and technology; cost the Research Nurse time required for the trial; and finalise sample size requirements for the larger trial. Participants will be eligible for inclusion in this trial if they are a medical or surgical patient over the age of 18 and are having a peripheral intravenous catheter inserted as part of their therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to have their PVC dressed and secured with either standard care (control) or one of two securement bundles (intervention). Daily follow ups will then be carried out by a Research Nurse until the time of device removal.
Interventions
Intervention arms:
1. Intervention group 1
• Control
PLUS
• Sterile tape strip in chevron pattern around hub (Steristrips)
• Sterile tape strip over hub (Steristrips)
• Non-sterile tape over any extension tubing
2. Intervention group 2:
• Intervention group 1
PLUS
• Non-compression tubular bandage (Tubifast 15cm)
The study intervention/s and control intervention will be applied by the PIVC inserter (research nurse and vascular access specialist) as per treatment allocation. After insertio
Intervention arms: 1. Intervention group 1 • Control PLUS • Sterile tape strip in chevron pattern around hub (Steristrips) • Sterile tape strip over hub (Steristrips) • Non-sterile tape over any extension tubing 2. Intervention group 2: • Intervention group 1 PLUS • Non-compression tubular bandage (Tubifast 15cm) The study intervention/s and control intervention will be applied by the PIVC inserter (research nurse and vascular access specialist) as per treatment allocation. After insertion and initial dressing and securement of the PIVC, all PIVCs will be maintained by clinical staff as per hospital policy. This includes: routine review of PIVCs by nursing staff at least once per shift and medical staff at least daily, specifically for the ongoing need for cannula, the state of the dressing, cannula patency and presence of complications; and a regular flushing regime of 5 – 10 mls of 0.9% Sodium Chloride administered using a pulsatile positive pressure technique if no continuous infusion is running. Nurses maintaining the PIVC will be responsible for any dressing changes or additional securement products, and these will be recorded by the research staff. The timing of removal of PIVCs will be determined by the clinical team using usual hospital criteria, namely PIVC complication necessitating removal, 72 hourly resite (it is standard practice in the hospital for PIVCs to be routinely resited at 72 hours), and/or completion of therapy. Protocol adherence will be collected daily by the research nurse and described descriptively as per the primary outcome. Extensive education sessions and written materials will be provided to staff to enhance protocol adherence.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 18 years or over • Requires a PIVC for > 24 hours • Ability to provide informed consent
Exclusion criteria
• Non-English speaking without an interpreter • Current BSI (within 24 hours of screening), with the exclusion of a single common skin contaminant (Reference: Centers of Disease Control and Prevention. National Healthcare Safety Network (NHSN) Patient Safety Component Manual. Washington, DC: Centers of Disease Control and Prevention, 2019) • Known allergy to any study product • Current skin tear, or deemed at high risk of skin tear by PIVC inserter • Previous recruitment to study
Outcome results
None listed