Innovation in Central Venous Access Device Security: A Pilot Randomized Controlled Trial in Pediatric Critical Care

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Ullman, Amanda J
Long, Debbie
Williams, Tara
Pearson, Kylie
Mihala, Gabor
Mattke, Adrian C
Macfarlane, Fiona
Rickard, Claire M
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2019
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Abstract

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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Pediatric Critical Care Medicine

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20

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10

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© 2019 Lippincott Williams & Wilkins. This is a non-final version of an article published in final form in Pediatric Critical Care Medicine, October 2019 - Volume 20 - Issue 10 - p e480-e488. Reproduced in accordance with the copyright policy of the publisher. Please refer to the journal link for access to the definitive, published version.

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Nursing

Science & Technology

Life Sciences & Biomedicine

Critical Care Medicine

Pediatrics

General & Internal Medicine

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Ullman, AJ; Long, D; Williams, T; Pearson, K; Mihala, G; Mattke, AC; Macfarlane, F; Rickard, CM, Innovation in Central Venous Access Device Security: A Pilot Randomized Controlled Trial in Pediatric Critical Care, Pediatric Critical Care Medicine, 2019, 20 (10), pp. E480-E488

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