Central venous Access device SeCurement And Dressing Effectiveness (CASCADE) in paediatrics: protocol for pilot randomised controlled trials.
Paediatric central venous access devices (CVADs) are associated with a 25% incidence of failure. Securement and dressing are strategies used to reduce failure and complication; however, innovative technologies have not been evaluated for their effectiveness across device types. The primary aim of this research is to evaluate the feasibility of launching a full-scale randomised controlled efficacy trial across three CVAD types regarding CVAD securement and dressing, using predefined feasibility criteria.
Three feasibility randomised, controlled trials are to be undertaken at the Royal Children's Hospital and the Lady Cilento Children's Hospital, Brisbane, Australia. CVAD securement and dressing interventions under examination compare current practice with sutureless securement devices, integrated securement dressings and tissue adhesive. In total, 328 paediatric patients requiring a peripherally inserted central catheter (n=100); non-tunnelled CVAD (n=180) and tunnelled CVAD (n=48) to be inserted will be recruited and randomly allocated to CVAD securement and dressing products. Primary outcomes will be study feasibility measured by eligibility, recruitment, retention, attrition, missing data, parent/staff satisfaction and effect size. CVAD failure and complication (catheter-associated bloodstream infection, local infection, venous thrombosis, occlusion, dislodgement and breakage) will be compared between groups.
Ethical approval to conduct the research has been obtained. All dissemination will be undertaken using the CONSORT Statement recommendations. Additionally, the results will be sent to the relevant organisations which lead CVAD focused clinical practice guidelines development.
ACTRN12614001327673; ACTRN12615000977572; ACTRN12614000280606.
Ullman AJ
，Kleidon T
，Gibson V
，Long DA
，Williams T
，McBride CA
，Hallahan A
，Mihala G
，Cooke M
，Rickard CM
... -
《BMJ Open》
Dressings and securement devices to prevent complications for peripheral arterial catheters.
Peripheral arterial catheters (ACs) are used in anaesthesia and intensive care settings for blood sampling and monitoring. Despite their importance, ACs often fail, requiring reinsertion. Dressings and securement devices maintain AC function and prevent complications such as infection.
To evaluate the effectiveness of peripheral AC dressing and securement devices to prevent failure and complications in hospitalised people.
We searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL Plus up to 16 May 2023. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform up to 16 May 2023.
We included randomised controlled trials (RCTs) comparing different dressing and securement devices for the stabilisation of ACs in hospitalised people.
Two review authors independently selected trials for inclusion, extracted data, and assessed risk of bias using Cochrane's RoB 1 tool. We resolved disagreements by discussion, or by consulting a third review author when necessary. We assessed the certainty of evidence using GRADE.
We included five RCTs with 1228 participants and 1228 ACs. All included studies had high risk of bias in one or more domains. We present the following four comparisons, with the remaining comparisons reported in the main review. Standard polyurethane (SPU) plus tissue adhesive (TA) compared with SPU: we are very uncertain whether use of SPU plus TA impacts rates of AC failure (risk ratio (RR) 0.44, 95% confidence interval (CI) 0.20 to 0.98; I² = 0%; 2 studies, 165 participants; very low-certainty evidence). Neither study (165 participants) reported catheter-related bloodstream infections (CRBSI), thus we are very uncertain whether SPU plus TA impacts on the incidence of CRBSI (very low-certainty evidence). It is very uncertain whether use of SPU plus TA impacts AC dislodgement risk (RR 0.54, 95% CI 0.03 to 9.62; I² = 44%; 2 studies, 165 participants; very low-certainty evidence). We are very uncertain whether use of SPU plus TA impacts AC occlusion rates (RR 1.20, 95% CI 0.37 to 3.91; I² = 3%; 2 studies, 165 participants; very low-certainty evidence). We are very uncertain whether use of SPU plus TA impacts rates of adverse events with few reported events across groups (RR 0.89, 95% CI 0.09 to 8.33; I² = 0%; 2 studies, 165 participants; very low-certainty evidence). Bordered polyurethane (BPU) compared to SPU: we are very uncertain whether use of BPU impacts rates of AC failure (RR 0.67, 95% CI 0.21 to 2.13; 1 study, 60 participants; very low-certainty evidence). BPU may make little or no difference to CRBSI compared to SPU (RR 3.05, 95% CI 0.12 to 74.45; I² = not applicable as 1 study (60 participants) reported 0 events; 2 studies, 572 participants; low-certainty evidence). BPU may make little or no difference to the risk of AC dislodgement compared with SPU (RR 0.75, 95% CI 0.17 to 3.22; I² = 0%; 2 studies, 572 participants; low-certainty evidence). BPU may make little or no difference to occlusion risk compared with SPU (RR 0.80, 95% CI 0.60 to 1.07; I² = 0%; 2 studies, 572 participants; low-certainty evidence). It is very uncertain whether BPU impacts on the risk of adverse events compared with SPU (RR 0.33, 95% CI 0.01 to 7.87; 1 study, 60 participants; very low-certainty evidence). SPU plus sutureless securement devices (SSD) compared to SPU: we are very uncertain whether SPU plus SSD impacts risk of AC failure compared with SPU (RR 0.78, 95% CI 0.40 to 1.52; I² = 0%; 2 studies, 157 participants; very low-certainty evidence). We are very uncertain if SPU plus SSD impacts CRBSI incidence rate with no events in both groups (2 studies, 157 participants; very low-certainty evidence). It is very uncertain whether SPU plus SSD impacts risk of dislodgement (RR 0.14, 95% CI 0.01 to 2.57; I² = not applicable as 1 study (96 participants) reported 0 events; 2 studies, 157 participants; very low-certainty evidence). It is very uncertain whether SPU plus SSD impacts risk of AC occlusion (RR 1.94, 95% CI 0.50 to 7.48; I² = 38%; 2 studies, 157 participants; very low-certainty evidence). We are very uncertain whether SPU plus SSD impacts on the risk of adverse events (RR 1.94, 95% CI 0.19 to 20.24; I² = not applicable as 1 study (96 participants) reported 0 events; 2 studies, 157 participants; very low-certainty evidence). Integrated securement dressings compared to SPU: integrated securement dressings may result in little or no difference in risk of AC failure compared with SPU (RR 1.96, 95% CI 0.80 to 4.84; 1 study, 105 participants; low-certainty evidence); may result in little or no difference in CRBSI incidence with no events reported (1 study, 105 participants; low-certainty evidence); may result in little or no difference in the risk of dislodgement (RR 0.33, 95% CI 0.04 to 3.04; 1 study, 105 participants; low-certainty evidence), may result in little or no difference in occlusion rates with no events reported (1 study, 105 participants; low-certainty evidence), and may result in little or no difference in the risk of adverse events (RR 0.35, 95% CI 0.01 to 8.45; 1 study, 105 participants; low-certainty evidence).
There is currently limited rigorous RCT evidence available about the relative clinical effectiveness of AC dressing and securement products. Limitations of current evidence include small sample size, infrequent events, and heterogeneous outcome measurements. We found no clear difference in the incidence of AC failure, CRBSI, or adverse events across AC dressing or securement products including SPU, BPU, SSD, TA, and integrated securement products. The limitations of current evidence means further rigorous RCTs are needed to reduce uncertainty around the use of dressing and securement devices for ACs.
Schults JA
，Reynolds H
，Rickard CM
，Culwick MD
，Mihala G
，Alexandrou E
，Ullman AJ
... -
《Cochrane Database of Systematic Reviews》
Complications associated with subsequent tunneled central venous access device placement in children: a retrospective cohort study.
Central venous access devices (CVADs) are vital instruments in pediatric healthcare, enabling the administration of critical treatments such as chemotherapy and parenteral nutrition. However, despite their advantages, CVADs carry a significant risk of complications, including infections, mechanical failures, and thrombotic events. From the current literature, it is unknown whether previous CVAD placements lead to an increased risk for complications in subsequent CVAD placements. We retrospectively analyzed data regarding tunneled, surgically implanted CVADs in children over a period of 2 years at a single tertiary pediatric center regarding their complications. Between 2021 and 2022, 328 CVAD implantations were performed in 313 children. The average age at implantation was 6.6 ± 5.5 years, while most of the patients were younger than 5 years old. During the study period, a total of 102 complications occurred in 96 patients. Most frequent complications were infections (18.29% of all implantations), followed by dislocation of the catheter tip (6.4 0%) and mechanical dysfunctions (4.27%). No patient died from a complication. The choice of catheter type (Port versus Broviac) showed a significant influence on the occurrence of complications (hazard ratio of 3.964 (95% CI 1.993-7.886; p < 0.001). The risk of infection and dislodgement was also higher when comparing Broviac with Ports implantations (infection: HR = 3.236; 95% CI 1.239-8.454; p = 0.017; dislodgement: HR = 5.781; 95% CI 1.229-27.193; p = 0.026). Cox regression showed a statistically significant higher risk of complications (especially infections) when the catheter was inserted via venous cutdown instead of percutaneous puncture technique (complications: HR = 6.709; 95% CI 1.776-25.337; p = 0.005; infections: HR = 7.28; 95% CI 1.096-48.379; p = 0.04). Cox regression did not show a statistically significant influence on complications for neither of the following factors: age, gender, weight, and oncological/non-oncological diagnosis. The complication rate for patients with previous CVAD was nearly the same as for patients who received a CVAD for the first time (previous CVAD: 29.17%; no previous CVAD: 30.74%).
Our study challenges conventional assumptions regarding the impact of previous CVAD placements on complication rates. Nevertheless, ongoing vigilance and adherence to standardized protocols remain crucial in mitigating risks and improving outcomes in pediatric CVAD management.
• Risk factors predisposing for CVAD-related complications remain insufficiently understood. • It is unknown whether previous CVAD placements lead to an increased risk for complications in subsequent CVAD placements.
• The complication rate for patients with previous CVAD appears to be the same as for patients who receive a CVAD for the first time.
Moraleda Guyol I
，Selvamoorthy T
，Siaj R
，Kolorz J
，Sabo J
，Berger M
，Jeske J
... -
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