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Innovation in Central Venous Access Device Security: A Pilot Randomized Controlled Trial in Pediatric Critical Care
Amanda J Ullman1,2,3, Debbie Long1,3, Tara Williams3
1Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia.
Insights
This pilot study found it feasible to test new methods for securing pediatric central venous access devices (CVADs). Integrated dressing securement showed promising results in reducing CVAD failure rates.
Area of Science:
- Pediatric critical care medicine
- Medical device securement technologies
- Clinical trial methodology
Background:
- Central venous access devices (CVADs) are vital for critical care but frequently fail (25%) due to issues like infection and dislodgement.
- Inadequate device securement and dressing are often implicated in CVAD failure, yet research on innovative pediatric securement methods is limited.
- This study assessed the feasibility of a larger trial investigating new technologies to improve pediatric CVAD securement.
Purpose of the Study:
- To determine the feasibility of conducting a definitive randomized controlled trial (RCT) on pediatric central venous access device securement.
- To evaluate the effectiveness of standard care versus new securement technologies (tissue adhesive, integrated dressing) in preventing CVAD failure.
- To gather preliminary data on CVAD complications, skin damage, and product costs.
Main Methods:
- A single-center, pilot randomized controlled trial involving 180 pediatric patients with nontunneled CVADs.
- Participants were randomized to three groups: standard care, standard care plus tissue adhesive, or integrated dressing securement.
- Feasibility was assessed through recruitment rates, protocol adherence, and acceptability; CVAD failure and complications were primary outcomes.
Main Results:
- Feasibility criteria were met, with acceptable recruitment, eligibility, and adherence rates.
- Overall CVAD failure was 6%; the integrated dressing group showed the lowest failure rate (2%), compared to standard care (6%) and tissue adhesive (8%).
- Acceptability was comparable between groups, though tissue adhesive was noted as difficult to apply.
Conclusions:
- Conducting a full efficacy RCT for these CVAD securement interventions is feasible.
- Further research is needed to identify clinically effective and cost-efficient methods for preventing pediatric CVAD failure using novel securement technologies.
- Integrated dressing securement appears promising for reducing CVAD failure in pediatric patients.
Objectives:
Central venous access devices enable many treatments during critical illness; however, 25% of pediatric central venous access devices fail before completion of treatment due to infection, thrombosis, dislodgement, and occlusion. This is frequently attributed to inadequate securement and dressing of the device; however, high-quality research evaluating pediatric central venous access device securement innovation to prevent central venous access device failure is scarce. This study aimed to establish the feasibility of a definitive randomized control trial examining the effectiveness of current and new technologies to secure central venous access devices in pediatrics.
Design:
Single-center, parallel group, superiority, pilot randomized control trial.
Setting:
Anesthetic and intensive care departments of a tertiary pediatric hospital SUBJECTS:: One-hundred eighty pediatric patients with nontunneled central venous access device INTERVENTIONS:: Participants were randomized to receive central venous access device securement via standard care (bordered polyurethane dressing, with prolene sutures, chlorhexidine gluconate disc), tissue adhesive (Histoacryl, B Braun, Melsungen, Germany) in addition to standard care; or integrated dressing securement (SorbaView SHIELD [Centurion Medical Products, Franklin, MA], with prolene sutures and chlorhexidine gluconate disc).
Outcomes:
Primary: Feasibility (including effect size estimates, acceptability); central venous access device failure; central venous access device complications; secondary: individual central venous access device complications, skin damage, dressing performance, and product cost.
Measurements And Main Results:
Feasibility criteria were achieved as recruitment occurred with acceptable eligibility, recruitment, missing data, and attrition rates, as well as good protocol adherence. Family members and staff-reported comparable levels of acceptability between study arms; however, tissue adhesive was reported as the most difficult to apply. Overall, 6% of central venous access devices failed, including 6% (3/54; incident rate, 13.2 per 1,000 catheter days) standard care, 2% (1/56; incident rate, 3.65 per 1,000 catheter days) integrated, and 8% (5/59; 25.0 per 1,000 catheter days) tissue adhesive.
Conclusions:
It is feasible to conduct an efficacy randomized control trial of the studied interventions. Further research is required to definitively identify clinical, cost-effective methods to prevent central venous access device failure by examining new dressing and securement technologies and techniques.
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