Central Venous Access Device-Associated Skin Complications in Adults with Cancer: A Prospective Observational Study.

OBJECTIVES: To identify the prevalence and type of central venous access device-associated skin complications for adult cancer patients, describe central venous access device management practices, and identify clinical and demographic characteristics associated with risk of central venous access device-associated skin complications. METHODS: A prospective cohort study of 369 patients (626 central venous access devices; 7,682 catheter days) was undertaken between March 2017 and March 2018 across two cancer care in-patient units in a large teaching hospital. RESULTS: Twenty-seven percent (n = 168) of participants had a central venous access device-associated skin complication. In the final multivariable analysis, significant (P < .05) risk factors for skin complications were cutaneous graft versus host disease (2.1 times greater risk) and female sex (1.4 times greater risk), whereas totally implanted vascular access device reduced risk for skin complications by two-thirds (incidence risk ratio 0.37). CONCLUSION: Central venous access device-associated skin complications are a significant, potentially avoidable injury, requiring cancer nurses to be aware of high-risk groups and use evidence-based preventative and treatment strategies. IMPLICATIONS FOR PRACTICE: This study has confirmed how common these potentially preventable injuries are. Therefore, the prevalence of these complications could be reduced by focusing on improvements in skin assessment, reductions in central venous access device dressing variation and improving clinician knowledge of this injury.

An mHealth application for chronic vascular access: A multi-method evaluation.

BACKGROUND: Healthcare consumers require diverse resources to assist their navigation of complex healthcare interactions, however, these resources need to be fit for purpose. AIM: In this study, we evaluated the utility, usability and feasibility of children, families and adults requiring long-term intravenous therapy using a recently developed mobile health application (App), intravenous (IV) Passport. DESIGN: Multi-site, parallel, multi-method, prospective cohort study. METHODS: A multi-site, multi-method study was carried out in 2020-2021, with 46 participants (20 adults, 26 children/family) reporting on their experiences surrounding the use of the IV Passport for up to 6 months. RESULTS: Overall, utility rates were acceptable, with 78.3% (N = 36) using the IV Passport over the follow-up period, with high rates of planned future use for those still active in the project (N = 21; 73%), especially in the child/family cohort (N = 13; 100%). Acceptability rates were high (9/10; IQR 6.5-10), with the IV Passport primarily used for documenting new devices and complications. Thematic analysis revealed three main themes (and multiple subthemes) in the qualitative data: Advocacy for healthcare needs, Complexity of healthcare and App design and functionality. CONCLUSION: Several recommendations were made to improve the end-user experience including 'how to' instructions; and scheduling functionality for routine care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: The IV Passport can be safely and appropriately integrated into healthcare, to support consumers. IMPACT: Patient-/parent-reported feedback suggests the Intravenous Passport is a useful tool for record-keeping, and positive communication between patients/parents, and clinicians. REPORTING METHOD: Not applicable. PATIENT CONTRIBUTION: Consumers reported their experiences surrounding the use of the IV Passport for up to 6 months.

Problem-solving processes for central venous catheter occlusion within pediatric cancer care: A qualitative study.

PURPOSE: Central venous access devices play a crucial role in healthcare settings. However, there is concern regarding the high incidence of blockages occurring before the completion of treatments and existing guidelines for occlusion management are not consistently followed. To explore the decision-making and problem-solving process of occlusion management and identify enablers and barriers to implementing evidence for occlusion management in pediatric cancer care. METHODS: A qualitative design with individual semi-structured interviews. Participants were selected by purposeful sampling from a tertiary-referral pediatric facility, and semi-structured interviews were conducted. RESULTS: A total of 13 clinicians and 5 parents were interviewed. The thematic analysis revealed four main decision-making/problem-solving themes: 1) clinical reasoning and judgement for central venous access devices occlusion, 2) capability in central venous access devices occlusion management, 3) colleague collaboration in the escalation process and 4) lack of adequate support to manage the occlusion. This study identified positive and negative influences on the problem-solving process, including clinicians' psychological capabilities, social and physical resources, and beliefs about consequences. CONCLUSION: This study found that clinicians in pediatric cancer care were able to manage central venous access device occlusions using clinical reasoning and judgment skills, which may conflict with evidence-based practices. The study confirmed the importance of a team approach and prior experience in managing central venous access devices in pediatric oncology settings and identified potential conflicts between clinician decisions based on the patient's current and anticipated conditions and implementation of evidence-based practice. Improving documentation and providing visual aids could benefit clinicians' problem-solving processes.

An mHealth application for chronic vascular access: Consumer led co-creation.

PURPOSE: Children with chronic and complex health conditions frequently need intravenous devices. The current approach to intravenous device selection, insertion, and monitoring is inconsistent, and healthcare consumers are often negatively affected by siloed health information, and poor future planning. Despite child- and family-centred care being recognised as a pillar of paediatric nursing care, limited implementation for vascular access device planning and management is evident. DESIGN AND METHODS: To address this, we conducted a multi-phased approach to co-create, then evaluate, a mobile health (mHealth) application: IV Passport. Co-creation involved a prioritisation survey, followed by a Passport advisory panel consensus meeting. Following confirmation of the required content and features of the Passport, the mHealth application was designed and content validation achieved via survey. RESULTS: The prioritisation survey yielded recommendations for seven features (e.g., graphical presentations of current/past devices). Content for nine device types (e.g., totally implanted ports) was suggested, each with 10 related items (e.g., insertion site). Content items for device-associated complications, future vascular access plans, and educational resources were also suggested. Following design, the application was released through Apple and Android platforms; and adapted to a paper version. Content validation was established; 100% strongly agreed the application was easy to use; 80% agreed/strongly agreed that they would recommend the Passport to others. CONCLUSION: IV Passport embodies effective child- and family-centred care through consumer co-creation to empower patients and families manage vascular access devices. PRACTICE IMPLICATIONS: IV Passport remains active; and can be utilised across many healthcare settings and patient populations.

Routine Catheter Lock Solutions in Pediatric Cancer Care: A Pilot Randomized Controlled Trial of Heparin vs Saline.

BACKGROUND: Central venous access devices (CVADs) are integral to cancer care provision. Despite the high prevalence of CVAD complications in children with cancer, preventative strategies are understudied. OBJECTIVE: The aim of this study was to assess study feasibility, occlusive events, thrombolytic use, adverse events, and direct costs of catheter lock solutions. METHODS: A single-center, parallel-group, pilot randomized controlled trial was undertaken at a tertiary-referral pediatric hospital in Australia. Children 18 years or younger with an oncological or malignant hematological condition and a CVAD were eligible. Participants were 1:1 randomized to (1) normal or (2) heparinized (10-100 U/mL; CVAD-type dependent) saline lock solutions. RESULTS: Of 217 children assessed for eligibility, 61 were recruited and randomized to normal (n = 30; 3850 CVAD days) or heparinized (n = 31; 4036 CVAD days) saline. Eligibility (52%) and recruitment (54%) feasibility targets were not met. Protocol adherence was high (95% assessments), with no attrition. Parent/clinician satisfaction of interventions was high (median, 10/10 clinicians/parents). Complete CVAD occlusion occurred in heparin only (n = 2, 6.7% CVADs; incidence rate [IR], 0.49/1000 CVAD days [0.06-1.78]). Central venous access device partial occlusion was detected in 23.3% of CVADs in heparin (n = 7; IR, 2.73/1000 CVAD days [1.36-4.87]) and 13.8% of CVADs in normal saline (n = 4; IR, 2.59/1000 CVAD days [1.24-4.77]). Thrombolytic agents were used in 16.7% heparin (5 CVADs) and 3.5% normal saline (1 CVAD). Adverse events did not differ between groups. CONCLUSION: Multisite randomized controlled trials examining CVAD locks are safe, but strategies and resources to increase recruitment and eligibility are required. IMPLICATIONS FOR PRACTICE: Both routine CVAD lock solutions seem safe but may not prevent all forms of CVAD-associated harm.

Do antimicrobial and antithrombogenic peripherally inserted central catheter (PICC) materials prevent catheter complications? An analysis of 42,562 hospitalized medical patients.

OBJECTIVE: To examine the effectiveness of antimicrobial and antithrombogenic materials incorporated into peripherally inserted central catheters (PICCs) to prevent bloodstream infection, thrombosis, and catheter occlusion. METHODS: Prospective cohort study involving 52 hospitals participating in the Michigan Hospital Medicine Safety Consortium. Sample included adult hospitalized medical patients who received a PICC between January 2013 and October 2019. Coated and impregnated catheters were identified by name, brand, and device marketing or regulatory materials. Multivariable Cox proportional hazards models with robust sandwich standard error estimates accounting for the clustered nature of data were used to identify factors associated with PICC complications in coated versus noncoated devices across general care, intensive care unit (ICU), and oncology patients. Results were expressed as hazard ratios (HRs) with corresponding 95% confidence intervals (CIs). RESULTS: Of 42,562 patients with a PICC, 39,806 (93.5%) were plain polyurethane, 2,263 (5.3%) incorporated antimicrobial materials, and 921 (2.2%) incorporated antithrombogenic materials. Most were inserted in general ward settings (n = 28,111, 66.0%), with 12, 078 (28.4%) and 1,407 (3.3%) placed in ICU and oncological settings, respectively. Within the entire cohort, 540 (1.3%) developed thrombosis, 745 (1.8%) developed bloodstream infection, and 4,090 (9.6%) developed catheter occlusion. Adjusting for known risk factors, antimicrobial PICCs were not associated with infection reduction (HR, 1.16; 95% CI, 0.82-1.64), and antithrombogenic PICCs were not associated with reduction in thrombosis and occlusion (HR, 1.15; 95% CI, 0.92-1.44). Results were consistent across populations and care settings. CONCLUSIONS: Antimicrobial and antithrombogenic PICCs were not associated with a reduction in major catheter complications. Guidance aimed at informing use of these devices, balancing benefits against cost, appear necessary.

Peripheral intravenous catheter failure: A secondary analysis of risks from 11,830 catheters.

BACKGROUND: Peripheral intravenous catheters are an essential medical device which are prone to complications and failure. OBJECTIVES: Identify patient, provider and device risk factors associated with all-cause peripheral intravenous catheter failure as well as individual complications: phlebitis, infiltration/occlusion, and dislodgement to improve patient outcomes. DESIGN: Secondary analysis of twelve prospective studies performed between 2008 and 2020. SETTINGS: Australian metropolitan and regional hospitals including one paediatric hospital. PARTICIPANTS: Participants were from medical, surgical, haematology, and oncology units. METHODS: Multilevel mixed-effects parametric survival regression was used to identify factors associated with all-cause peripheral intravenous catheter failure, phlebitis, occlusion/infiltration, and dislodgement. We studied patient (e.g., age, gender), device (e.g., gauge), and provider (e.g., inserting clinician) variables. Stepwise regression involved clinically and p<0.20 significant variables entered into the multivariable model. Results were expressed as hazard ratios (HRs) and 95% confidence intervals (CI); p<0.01 was considered statistically significant. RESULTS: Of 11,830 peripheral intravenous catheters (8,200 participants) failure occurred in 36% (n = 4,263). Occlusion/infiltration incidence was 23% (n = 2,767), phlebitis 12% (n = 1,421), and dislodgement 7% (n = 779) of catheters. Patient factors significantly associated with failure and complications were: female gender (phlebitis; (HR 1.98, 95% CI 1.72-2.27), (infiltration/occlusion; HR 1.45, 95% CI 1.33-1.58), (failure; HR 1.36, 95% CI 1.26-1.46); and each year increase in age (phlebitis; 0.99 HR, 95% CI 0.98-0.99), (failure; 0.99 HR, 95% CI 0.99-0.99). The strongest provider risk factor was intravenous antibiotics (infiltration/occlusion; HR 1.40, 95% CI 1.27-1.53), (phlebitis; HR 1.36, 95% CI 1.18-1.56), (failure; HR 1.26, 95% CI 1.17-1.36). Catheters inserted by vascular access teams were less likely to dislodge (HR 0.53, 95% CI 0.42-0.67). Device risk factors most associated with all-cause failure were wrist/hand (HR 1.34, 95% CI 1.23-1.46), antecubital fossa peripheral intravenous catheters (HR 1.29, 95% CI 1.16-1.44) and 22/24 gauge (HR 1.27, 95% CI 1.12-1.45) catheters. CONCLUSION: Factors identified, including the protective aspect of vascular access team insertion, and high catheter failure associated with intravenous antibiotic administration, will allow targeted updates of peripheral intravenous catheter guidelines and models of care.

Comparison of midline catheters and peripherally inserted central catheters to reduce the need for general anesthesia in children with respiratory disease: A feasibility randomized controlled trial.

BACKGROUND: The optimal intravenous device for antibiotic administration for children with respiratory disease is uncertain. We assessed the feasibility of a randomized controlled trial comparing midline catheters with peripherally inserted central catheters. METHODS: Prospective, two-arm, feasibility randomized controlled trial in an Australian tertiary, pediatric hospital. Random assignment of 110 children (<18 years) to receive (i) midline catheter and (ii) peripherally inserted central catheters. Primary outcome was feasibility (eligibility, recruitment, retention, protocol adherence, and acceptability), and the primary clinical outcome was general anesthesia requirement for intravenous catheter insertion. SECONDARY OUTCOMES: insertion time, treatment delays, infusion efficiency, device failure, complications, and cost. RESULTS: There was 80% recruitment, 100% retention, no missing data, and high patient/staff acceptability. Mean patient experience assessed on a 0-10 numeric rating scale was 8.0 peripherally inserted central catheters and 9.0 (midline catheters), respectively. Participant eligibility was not achieved (49% of screened patients) and moderate protocol-adherence across groups (89% peripherally inserted central catheters vs. 76% midline catheter). Insertion of midline catheter for pulmonary optimization reduced the requirement for general anesthesia compared to peripherally inserted central catheters (10% vs. 69%; odds ratio = 0.01, 95% confidence interval: 0.00-0.09). Midline catheters failed more frequently (18.1 vs. 5.5 peripherally inserted central catheters per 1000 catheter-days); however, this reduced over trial duration. Midline catheter insertion compared to peripherally inserted central catheters saved AUD$1451 per pulmonary optimization episode. CONCLUSIONS: An efficacy trial is feasible with expanded eligibility criteria and intensive staff training when introducing a new device. Midline catheter for peripherally compatible infusions is acceptable to patients and staff, might negate the need for general anesthesia and results in significant cost savings.

Peripherally Inserted Central Catheter Thrombosis After Placement via Electrocardiography vs Traditional Methods.

BACKGROUND: Peripherally inserted central catheter tip placement at the cavoatrial junction is associated with reduced catheter-related deep vein thrombosis. Electrocardiographic tip confirmation purportedly improves accuracy of tip placement, but whether this approach can reduce deep vein thrombosis is unknown. METHODS: Prospectively collected data from patients that received peripherally inserted central catheters at 52 Michigan hospitals were analyzed. The method used to confirm tip confirmation at insertion and deep vein thrombosis outcomes were extracted from medical records. Multivariate models (accounting for the clustered nature of the data) were fitted to assess the association between peripherally inserted central catheter-related deep vein thrombosis and method of tip confirmation (electrocardiographic vs radiographic imaging). RESULTS: A total of 42,687 peripherally inserted central catheters (21,098 radiology vs 21,589 electrocardiographic) were included. Patients receiving electrocardiographic-confirmed peripherally inserted central catheters had fewer comorbidities compared with those that underwent placement via radiology. Overall, deep vein thrombosis occurred in 594 (1.3%) of all peripherally inserted central catheters. Larger catheter size (odds radio [OR] 1.32; 95% confidence interval [CI], 0.93-1.90 per unit increase in gauge), history of deep vein thrombosis, and cancer were associated with increased risk of deep vein thrombosis (OR 2.00; 95% CI, 1.65-2.43 and OR 1.62; 95% CI, 1.16-2.26, respectively) using logistic regression. Following adjustment, electrocardiographic guidance was associated with a significant reduction in peripherally inserted central catheter-related deep vein thrombosis compared with radiographic imaging (OR 0.74; 95% CI, 0.58-0.93; P = .0098). CONCLUSION: The use of electrocardiography to confirm peripherally inserted central catheter tip placement at the cavoatrial junction was associated with significantly fewer deep vein thrombosis events than radiographic imaging. Use of this approach for peripherally inserted central catheter insertion may help improve patient safety, particularly in high-risk patients.

Prevention of occlusion of cEnTral lInes for children with cancer: An implementation study.

AIM: Central venous access devices (CVADs) are vital medical devices to support the treatment of paediatric cancer; however, device occlusion is common, which disrupts treatment. This study aimed to improve the identification and management of CVAD occlusions in children with cancer, as well as to identify the demographic, clinical and device characteristics associated with increased risk for CVAD occlusion. METHODS: A pre-post-implementation study was conducted at a metropolitan paediatric oncology facility in Australia, using the Theoretical Domains Framework. Patients with a CVAD for anti-cancer therapy were prospectively followed for occlusive events pre- and post- the implementation of clinical resources to support the identification and management of CVAD occlusive events. CVAD occlusion and management data were collected and compared pre- and post-implementation. Risk factors for CVAD occlusion were described by mixed-effects Poisson regression and incident rate ratios (IRR). RESULTS: A total of 133 CVADs were inserted into 131 patients for a total of 6784 catheter days. The incidence of CVAD-related occlusion pre-implementation was 59.7 (95% confidence interval (CI) 51.4-69.0, per 1000 catheter days); compared to 31.6 (95% CI 26.4-37.6); P < 0.01) post-implementation of clinical resources. In multivariate models, other than post-implementation phases (IRR 0.51 (95% CI 0.32-0.81)), only neutropaenia significantly increased the risk of CVAD occlusion (IRR 2.14 (95% CI 1.15-3.97)). CONCLUSION: CVAD occlusions in paediatric oncology are common. The development and implementation of CVAD occlusion resources to guide the identification and management of occlusive episodes led to a significant decrease in occlusive events.

Developing Appropriateness Criteria for Pediatric Vascular Access.

OBJECTIVES: To describe the methodology undertaken to provide guidance on the appropriateness, as well as inappropriateness, of vascular access device selection, characteristics, and insertion technique for pediatric patients. METHODS: The RAND Corporation-University of California, Los Angeles Appropriateness Method was used. After definition of key terms and scope, a systematic review of the pediatric vascular access literature was undertaken. Clinical scenarios were developed to reflect the common indications for vascular access across pediatric health care. These were sectioned according to (1) device selection, (2) device characteristics, and (3) insertion technique. An interdisciplinary panel of experts (N = 14) consisting of leading experts representing diverse pediatric clinical disciplines including anesthesiology, cardiology and cardiac surgery, critical care and emergency, general surgery, hematology and oncology, hospital medicine, infectious disease, interventional radiology, pharmacology, regional pediatric hospitalist, and vascular access nursing specialties was convened. The scenarios were rated for appropriateness by the panel over 2 rounds (1 [highly inappropriate] to 9 [highly appropriate]). Round 1 ratings were completed anonymously and independently by panel members and classified into 3 levels of appropriateness: appropriate, uncertain, and inappropriate, or disagreement. For round 2, panelists met in-person to discuss the round 1 ratings and independently rerated the indications. All indications were reclassified into 3 levels of appropriateness or disagreement. CONCLUSIONS: The RAND Corporation-University of California, Los Angeles Appropriateness Method provides a rigorous, in-depth and transparent methodology to develop the first appropriateness criteria for the selection of pediatric vascular access devices in a range of patient groups.

Development of a paediatric central venous access device database: A retrospective cohort study of practice evolution and risk factors for device failure.

AIM: To describe practice evolution, complications and risk factors for multiple insertion attempts and device failure in paediatric central venous access devices (CVADs). METHODS: A paediatric retrospective cohort study using prospectively collected data from CVAD database 2012-2014. Data included were patient (i.e. age, condition), insertion (i.e. indication, device, technique) and removal (complications, dwell). Descriptive statistics and incidence rates were calculated per calendar year and compared. Risk factors for multiple insertion attempts and failure were explored with logistic regression and cox regression, respectively. RESULTS: A total of 1308 CVADs were observed over 273 467 catheter-days in 863 patients. Multiple insertion attempts remained static (14%) and significantly associated with non-haematological oncology (odds ratio 2.19; 95% confidence interval (CI) 1.08-4.43), respiratory (3.71; 1.10-12.5), gastroenterology (4.18; 1.66-10.5) and other (difficult intravenous access) (2.74; 1.27-5.92). CVAD failure decreased from 35% (2012) to 25% (2014), incidence rate from 1.50 (95% CI 1.25-1.80) to 1.28 (1.06-1.54) per 1000 catheter-days. Peripherally inserted CVAD failure was significantly associated with lower body weight (per kilogram decrease, hazard ratio (HR) 1.02; 95% CI 1.00-1.03), cephalic vein (1.62; 1.05-2.62), difficult access (1.92; 1.02-3.73), sub-optimal tip placement (1.69; 1.06-2.69) and gastroenterology diagnosis (2.27; 1.05-4.90). Centrally placed CVAD failure was significantly associated with younger age (per year, HR 1.04; 95% CI 1.00-1.07), tunnelled device (3.38; 2.41-4.73) and gastroenterology diagnosis (1.70; 1.06-2.73). CONCLUSIONS: While advancement in CVAD practices improved overall CVAD insertion and failure outcomes, further improvements and innovation are necessary to ensure improved vessel health and preservation for children requiring CVAD.

Skin Complications Associated With Pediatric Central Venous Access Devices: Prevalence, Incidence, and Risk.

Central venous access devices (CVADs) are vital to enable treatment for children with cancer and other complex health conditions. However, complications effecting the CVAD wound are commonly reported. This study aimed to identify the incidence and prevalence of CVAD-associated skin complications current management, and characteristics associated with complication development, in pediatrics. A prospective observational study performed across medical, oncology, and hematology departments at a tertiary pediatric hospital in Australia, between April and July 2017. Children admitted with CVADs were assessed twice weekly for CVAD-associated skin complications and associated signs and symptoms. The data were analyzed using descriptive statistics (i.e., proportions, frequency) and time-to-event multivariable regression (i.e., hazard ratios [HRs]). Two hundred and seventy-one CVADs were reviewed over 43,787 catheter days, with over one eighth of participants (14%; n = 37) having a CVAD-associated skin complication during their admission (0.95 per 1,000 catheter days, 95% confidence interval [CI; 0.61, 1.17]), most commonly contact dermatitis (11%; n = 29; 0.72 per 1,000 catheter days 95% CI [0.50, 1.04]). Within biweekly checks the median point prevalence of complications varied between 0.4% and 11% and clinical management was wide-ranging. A primary diagnosis of oncology (HR 2.89, 95% CI [1.10, 7.62]) or medical/surgical (HR 2.55, 95% CI [1.04, 6.22]) conditions; plain, nonbordered polyurethane dressings (HR 4.92, 95% CI [2.00, 12.13]); and poor dressing integrity (HR 2.64, 95% CI [1.18, 5.92]) were significantly associated with contact dermatitis. In conclusion, substantial numbers of pediatric patients experience CVAD-associated skin complications, and innovations are necessary to identify, prevent, and treat these health care-associated injuries.

Innovative dressing and securement of tunneled central venous access devices in pediatrics: a pilot randomized controlled trial.

BACKGROUND: Central venous access device (CVAD) associated complications are a preventable source of patient harm, frequently resulting in morbidity and delays to vital treatment. Dressing and securement products are used to prevent infectious and mechanical complications, however current complication rates suggest customary practices are inadequate. The aim of this study was to evaluate the feasibility of launching a full-scale randomized controlled efficacy trial of innovative dressing and securement products for pediatric tunneled CVAD to prevent complication and failure. METHODS: An external, pilot, four-group randomized controlled trial of standard care (bordered polyurethane dressing and suture), in comparison to integrated securement-dressing, suture-less securement device, and tissue adhesive was undertaken across two large, tertiary referral pediatric hospitals in Australia. Forty-eight pediatric participants with newly inserted tunneled CVADs were consecutively recruited. The primary outcome of study feasibility was established by elements of eligibility, recruitment, attrition, protocol adherence, missing data, parent and healthcare staff satisfaction and acceptability, and effect size estimates for CVAD failure (cessation of function prior to completion of treatment) and complication (associated bloodstream infection, thrombosis, breakage, dislodgement or occlusion). Dressing integrity, product costs and site complications were also examined. RESULTS: Protocol feasibility was established. CVAD failure was: 17% (2/12) integrated securement-dressing; 8% (1/13) suture-less securement device; 0% tissue adhesive (0/12); and, 0% standard care (0/11). CVAD complications were: 15% (2/13) suture-less securement device (CVAD associated bloodstream infection, and occlusion and partial dislodgement); 8% (1/12) integrated securement-dressing (partial dislodgement); 0% tissue adhesive (0/12); and, 0% standard care (0/11). One CVAD-associated bloodstream infection occurred, within the suture-less securement device group. Overall satisfaction was highest in the integrated securement-dressing (mean 8.5/10; standard deviation 1.2). Improved dressing integrity was evident in the intervention arms, with the integrated securement-dressing associated with prolonged time to first dressing change (mean days 3.5). CONCLUSIONS: Improving the security and dressing integrity of tunneled CVADs is likely to improve outcomes for pediatric patients. Further research is necessary to identify novel, effective CVAD securement to reduce complications, and provide reliable vascular access for children. TRIAL REGISTRATION: ACTRN12614000280606 ; prospectively registered on 17/03/2014.

Substantial harm associated with failure of chronic paediatric central venous access devices.

Central venous access devices (CVADs) form an important component of modern paediatric healthcare, especially for children with chronic health conditions such as cancer or gastrointestinal disorders. However device failure and complications rates are high.Over 2½ years, a child requiring parenteral nutrition and associated vascular access dependency due to 'short gut syndrome' (intestinal failure secondary to gastroschisis and resultant significant bowel resection) had ten CVADs inserted, with ninesubsequently failing. This resulted in multiple anaesthetics, invasive procedures, injuries, vascular depletion, interrupted nutrition, delayed treatment and substantial healthcare costs. A conservative estimate of the institutional costs for each insertion, or rewiring, of her tunnelled CVAD was $A10 253 (2016 Australian dollars).These complications and device failures had significant negative impact on the child and her family. Considering the commonality of conditions requiring prolonged vascular access, these failures also have a significant impact on international health service costs.

Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: the PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial.

INTRODUCTION: Around 30% of peripherally inserted central catheters (PICCs) fail from vascular, infectious or mechanical complications. Patients with cancer are at highest risk, and this increases morbidity, mortality and costs. Effective PICC dressing and securement may prevent PICC failure; however, no large randomised controlled trial (RCT) has compared alternative approaches. We designed this RCT to assess the clinical and cost-effectiveness of dressing and securements to prevent PICC failure. METHODS AND ANALYSIS: Pragmatic, multicentre, 2×2 factorial, superiority RCT of (1) dressings (chlorhexidine gluconate disc (CHG) vs no disc) and (2) securements (integrated securement dressing (ISD) vs securement device (SED)). A qualitative evaluation using a knowledge translation framework is included. Recruitment of 1240 patients will occur over 3 years with allocation concealment until randomisation by a centralised service. For the dressing hypothesis, we hypothesise CHG discs will reduce catheter-associated bloodstream infection (CABSI) compared with no CHG disc. For the securement hypothesis, we hypothesise that ISD will reduce composite PICC failure (infection (CABSI/local infection), occlusion, dislodgement or thrombosis), compared with SED. SECONDARY OUTCOMES: types of PICC failure; safety; costs; dressing/securement failure; dwell time; microbial colonisation; reversible PICC complications and consumer acceptability. Relative incidence rates of CABSI and PICC failure/100 devices and/1000 PICC days (with 95% CIs) will summarise treatment impact. Kaplan-Meier survival curves (and log rank Mantel-Haenszel test) will compare outcomes over time. Secondary end points will be compared between groups using parametric/non-parametric techniques; p values <0.05 will be considered to be statistically significant. ETHICS AND DISSEMINATION: Ethical approval from Queensland Health (HREC/15/QRCH/241) and Griffith University (Ref. No. 2016/063). Results will be published. TRIAL REGISTRATION: Trial registration number is: ACTRN12616000315415.