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Published on: July 13, 2019
Smile - Secure my intravenous line effectively: A pilot randomised controlled trial of peripheral intravenous
Tricia M Kleidon1, Claire M Rickard2, Victoria Gibson3
1Queensland Children's Hospital, Queensland, Australia; Alliance for Vascular Access Teaching and Research Group, Menzies Health Institute Queensland, Australia; Nursing & Midwifery Research Centre, Royal Brisbane and Women's Hospital, Queensland, Australia.
Insights
Integrated securement dressings (ISD) and tissue adhesive (TA) reduced peripheral intravenous catheter (PIVC) failure compared to bordered polyurethane dressings (BPU). A larger trial is feasible and necessary to confirm these findings for pediatric patients.
Area of Science:
- Pediatric critical care
- Vascular access devices
- Clinical trial methodology
Background:
- Peripheral intravenous catheters (PIVCs) are crucial for pediatric care but prone to failure.
- Current securement methods vary, impacting PIVC longevity and patient outcomes.
- Feasibility of rigorous testing for optimal PIVC securement in children is underexplored.
Purpose of the Study:
- To assess the feasibility of a randomized controlled trial (RCT) for pediatric PIVC securement.
- To compare the efficacy of three PIVC securement methods: bordered polyurethane dressing (BPU) + non-sterile foam (NSF), integrated securement dressing (ISD) + sterile foam (SF), and tissue adhesive (TA) + NSF.
- To evaluate PIVC failure rates and associated factors.
Main Methods:
- A pilot 3-arm RCT involving 330 children in an Australian pediatric hospital.
- Patients were randomized to receive BPU+NSF, ISD+SF, or TA+NSF securement.
- Primary outcomes were feasibility and PIVC failure; secondary outcomes included infections, occlusion, infiltration, dislodgement, phlebitis, and microbial colonization.
Main Results:
- High consent (98%) and retention (96%) rates confirmed trial feasibility, though eligibility (58%) was not met.
- A significant reduction in PIVC failure was observed with ISD (29%) compared to BPU (45%) (p=0.017).
- TA also showed a trend towards reduced PIVC failure (32%) versus BPU (p=0.052). Older age, no baseline infection, and specialist insertion were associated with reduced failure.
Conclusions:
- Integrated securement dressings (ISD) and tissue adhesive (TA) demonstrated reduced PIVC failure compared to bordered polyurethane dressings (BPU).
- A large-scale efficacy trial to statistically validate these findings is feasible and warranted.
- Optimizing PIVC securement is essential for improving pediatric patient care and reducing complications.
Aim:
Evaluate the feasibility of an efficacy randomised control trial (RCT) of paediatric peripheral intravenous catheter (PIVC) securement to prevent failure without resultant skin damage.
Methods:
A 3-arm, pilot RCT in an Australian paediatric hospital. Random assignment of 330 children to receive (i) bordered polyurethane dressing (BPU) + non-sterile foam (NSF), (ii) integrated securement dressing (ISD) + sterile foam (SF), or (iii) tissue adhesive (TA)+ NSF. Primary outcomes were feasibility and PIVC failure. Secondary outcomes included: skin/bloodstream infection; occlusion; infiltration; dislodgement; phlebitis; dwell; serious adverse events; acceptability and microbial colonisation of catheter tips, wound site, and foam.
Results:
Most feasibility outcomes were confirmed; 98% of eligible patients consented, 96% received their allocated dressing and no patients were lost to follow up. Eligilbility feasibility (58%) was not met. 11 randomised patients did not require a PIVC. Of 319 patients receiving a PIVC (20,716 PIVC-hours), a significant reduction in PIVC failure was demonstrated with ISD, 31/107 (29%, p = 0.017) compared to BPU, 47/105 (45%). Although not statistically significant, compared to BPU, TA 34/107 (32%, p = 0.052) was associated with less PIVC failure. On Cox regression, no securement intervention significantly reduced PIVC failure. Older age (HR 0.92; 95% confidence interval [CI] 0.88-0.96; p = <0.01), no infection at baseline (HR 0.51; 95% CI 0.34-0.78) and insertion by vascular access specialist (HR 0.40; 95% CI 0.26-0.64) were significantly associated with reduced failure (p < 0.05).
Conclusion:
ISD and TA had reduced PIVC failure compared to BPU. A large efficacy trial to test statistical differences is feasible and needed.
