How Does Your PICCOMPARE? A Pilot Randomized Controlled Trial Comparing Various PICC Materials in Pediatrics

Kleidon, Tricia; Ullman, Amanda; Zhang, Li; Mihala, Gabor; Chaseling, Brett; Schoutrop, Jason; Rickard, Claire M

doi:10.12788/jhm.2911

Cited by 22 publications

(42 citation statements)

References 30 publications

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“…Miyagaki et al's (2012) findings were not included in this meta-analysis as no thromboses were detected in this study. Overall, meta-analysis (including Kleidon et al, 2018) showed no significant difference in thrombosis between experimental and control arms (RR 0.98, 95% CI 0.87, 1.11), with low heterogeneity (I 2 = 0%; Figure 1). Sub-group analysis of thrombosis rates in studies assessing pediatric and adult populations was conducted.…”

Section: Primary Outcomementioning

confidence: 97%

Evaluating the Impact of Central Venous Catheter Materials and Design on Thrombosis: A Systematic Review and Meta‐Analysis

Slaughter

Kynoch

Brodribb

et al. 2020

Worldviews Ev Based Nurs

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Background: Thrombosis is a common complication associated with central venous catheter (CVC) insertion. Several antithrombogenic materials and alterations to catheter design have been developed to lower thrombosis rates. Aim: To systematically evaluate the effectiveness and safety of antithrombogenic materials and alterations to CVC design on thrombosis rates. Methods: A systematic search was completed of main databases (CINAHL, EMBASE, MEDLINE, and PubMed) as well as trial registries and gray literature. Randomized controlled trials conducted in any age group, published in English language since 2008 reporting impact of different CVC designs or materials on thrombosis were included, to capture studies that reflect contemporary products and practice. Cochrane systematic review methodology was followed, including independent study selection and data extraction. Quality appraisal was conducted using the Cochrane risk of bias tool. A narrative synthesis and meta-analysis in RevMan were conducted. Results: From a possible 232 studies, nine studies met the inclusion criteria. Four studies (n = 1,320) assessed different catheter materials; four studies (n = 591) compared different CVC designs, and one study (n = 150) evaluated impact of combined design and material on outcomes. Meta-analysis demonstrated that neither catheter material nor design alone or in combination had a significant impact on thrombosis (RR: 0.98 [95% CI 0.87, 1.11]). Different catheter materials and design also had no significant impact on occlusion or CRBSI. Studies were of mixed quality overall. Linking Evidence to Action: Different CVC materials and designs were not associated with a reduction in the risk of either catheter-related thrombosis or infection. Overall reporting and small sample sizes make it difficult to draw firm conclusions. Larger, quality randomized trials are required to provide evidence about the possible merits of innovative catheter design and materials on patient outcomes.

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Section: Primary Outcomementioning

confidence: 97%

Evaluating the Impact of Central Venous Catheter Materials and Design on Thrombosis: A Systematic Review and Meta‐Analysis

Slaughter

Kynoch

Brodribb

et al. 2020

Worldviews Ev Based Nurs

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“…This pilot RCT compared a hydrophobic polyurethane PICC with proximal valve with a power-injectable polyurethane PICC with external clamp to reduce PICC failure and complications in an adult population. This study followed the same methodology as the paediatric protocol [35] and published study [26] and was reported in line with the CONSORT guidelines. A quarter of PICCs failed (25/110; 23%) before treatment completion.…”

Section: Discussionmentioning

confidence: 99%

“…A recent pilot RCT in paediatric patients [26] compared a polyurethane, power-injected PICC with an external clamp to a hydrophobic polyurethane PICC (BioFlo®). Failure was halved in the hydrophobic polyurethane group (8/72; 11%) compared to standard care (16/74; 22%) (p = 0.087), which when expressed as an incident rate was 12.6 and 7.3 per 1000 PICC days (incident rate ratio 0.58; 95% confidence interval (CI) 0.21-1.43; p = 0.172).…”

Section: Introductionmentioning

confidence: 99%

A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial

Gavin

Kleidon

Larsen

et al. 2020

Trials

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Background To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC. Methods This pilot randomised controlled trial (RCT) was conducted between May 2017 and February 2018. Adult participants (n = 111) were assigned to hydrophobic polyurethane PICC with proximal valve (intervention) or a polyurethane PICC with external clamp (standard care). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were central line-associated bloodstream infection, local infection, occlusion, thrombosis, fracture and dislodgement, phlebitis, local or systemic allergic reaction, and PICC dwell time. Results All feasibility outcomes were achieved, apart from eligibility criteria. In total, 338 patients were screened, 138 were eligible (41%), and of these 111 were randomised (80%). Patients received the allocated PICC in 106 (95%) insertions. No patients withdrew from the study and there was no missing data. PICC failure was 24% (13/55) in the intervention group and 22% (12/55) in the standard care group (p = 0.820). PICC failure per 1000 PICC days was 16.3 in the intervention group and 18.4 in the control group (p = 0.755). The average dwell time was 12 days in the intervention and 8 days in the control group. Conclusions This study demonstrates the feasibility of an efficacy trial of PICC materials in an adult population, once adjustments were made to include not only in-patients, but also patients being discharged to the Hospital in the Home service. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12616001578493. Prospectively registered on 16 November 2016. The trial protocol was published a priori (Kleidon et al., Vasc Access 3:15–21, 2017).

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“…Therefore, when PICCs are trimmed to a more suitable length for pediatric patients (Interface Biologics 2017), the risk of thrombotic complications including occlusion is greatly reduced. A recent randomized control trial in pediatric inpatients demonstrated a 50% reduction in PICC failure when antithrombogenic catheters were used compared to a power injectable polyurethane PICC (Kleidon et al 2018). Additionally, significantly fewer complications such as occlusion occurred in patients with antithrombogenic PICCs.…”

Section: Catheter Materials and Designmentioning

confidence: 99%

Right Device Assessment and Selection in Pediatrics

Kleidon

Ullman

2019

Vessel Health and Preservation: The Right Approach for Vascular Access

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How Does Your PICCOMPARE? A Pilot Randomized Controlled Trial Comparing Various PICC Materials in Pediatrics

Abstract: BioFlo® PICCs appear potentially safer for pediatrics than traditional standard care PICCs with a clamp. Further research is required to definitively identify clinical, cost-effective methods to prevent PICC failure and improve reliability.

Cited by 22 publications

References 30 publications

Evaluating the Impact of Central Venous Catheter Materials and Design on Thrombosis: A Systematic Review and Meta‐Analysis

Evaluating the Impact of Central Venous Catheter Materials and Design on Thrombosis: A Systematic Review and Meta‐Analysis

A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial

Right Device Assessment and Selection in Pediatrics

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