Safety and efficacy of midline catheters versus peripheral intravenous catheters: A pilot randomized controlled trial

Background: Despite pervasive need for peripheral intravenous catheters, insertion is often difficult, and approximately two thirds fail prematurely. Midline catheters are an alternative long peripheral catheter, inserted in the upper arm, ideal for patients with difficult access. Aim: The aim of this study is to test feasibility of the protocol and compare the efficacy and safety of midline catheters to peripheral intravenous catheters. Design: A parallel-group, pilot randomized controlled trial of adult medical/surgical hospitalized patients, from a single Australian referral hospital. Methods: Participants with difficult vascular access (≤2 palpable veins) and/or anticipated ≥5 days of peripherally compatible intravenous therapy were recruited between May 2019 and March 2020. Participants were randomized to (1) peripheral intravenous catheter or (2) midline catheter. Primary feasibility outcome measured eligibility, recruitment, protocol adherence, retention and attrition. Primary clinical outcomes measured device insertion failure and post-insertion failure. Results: In total, n = 143 participants (71 peripheral intravenous catheters and 72 midline catheters) were recruited; n = 139 were analysed. Most feasibility criteria were met. Peripheral intravenous catheters had shorter functional dwell time, with higher incidence of post-insertion failure compared to midline catheters. Conclusion: Midline catheters appear to be superior for patients with difficult vascular access or receiving prolonged intravenous therapy; a large, multi-centre trial to confirm findings is feasible

Needleless connector decontamination for prevention of central venous access device infection: A pilot randomized controlled trial

Pilot randomized controlled trial (180 patients) of needleless connector decontamination. Central line-associated bloodstream infection occurred in 2% (1/61) of 70% isopropyl alcohol (IPA) wipe, 2% (1/59) of 70% IPA cap, and zero (0/58) infections in 2% chlorhexidine gluconate in 70% IPA wipe patients. Larger definitive trials are feasible and needed

Flushing of peripheral intravenous catheters: A pilot, factorial, randomised controlled trial of high versus low frequency and volume in paediatrics

Aim: To test the feasibility of an efficacy trial comparing different flushing frequencies and volumes to reduce peripheral intravenous cannula (PIVC) failure in paediatric inpatients. Methods: Pilot, 2 × 2 factorial, randomised controlled trial comparing PIVC flushing techniques in intervention pairs: (i) low volume (3 mL) versus high volume (10 mL); and (ii) low frequency (24 hourly) versus high frequency (6 hourly). Patients were excluded if: fluids were restricted, weight 24 h or continuous infusion. The primary end-point was feasibility (eligibility, recruitment, retention, protocol adherence, missing data and sample size estimates) of a large trial. Secondary end-points were PIVC failure (composite and individual), bloodstream infection and mortality. Results: A total of 919 children were screened from April to November 2015, with 55 enrolled. Screening feasibility criteria were not met, mainly due to continuous infusions and PIVCs in situ >24 h or planned for imminent removal. However, 80% of eligible participants consented, 2% withdrew, protocol adherence was 100%, and there was no missing primary end-point data. PIVC failure was significantly higher (hazard ratio = 2.90, 95% confidence interval: 1.11–7.54) in the 3 mL compared to the 10 mL group. There was no difference in failure between frequency groups (hazard ratio = 0.91, 95% confidence interval: 0.36–2.33). There was no interaction effect (P = 0.22). Conclusion: Trial feasibility proved challenging due to eligibility criteria, which could be improved with additional recruiting staff. Firm conclusions cannot be made based on this small sample, but flush volume may impact PIVC failure

Global pediatric peripheral intravenous catheter practice and performance : a secondary analysis of 4206 catheters

Purpose: To describe worldwide characteristics, performance and risk factors of peripheral intravenous catheters (PIVCs), in pediatrics. Design: A secondary, subgroup analysis of pediatric (2 years age (odds ratio [OR] > 1.58; 1.2–2.1); ambulance/emergency insertion (OR 1.65; 1.2–2.3); upper arm/antecubital placement (OR 1.44; 1.1–2.0); poor dressing integrity (OR 5.4; 4.2–6.9); and 24–72 h dwell (OR > 1.9; 1.3–2.6). Conclusions: There is global inconsistency in pediatric PIVC practice, which may be causing harm. Clinical implications: Improvements in pediatric PIVC placement, dressings, and gauge selection are needed

A Pilot Randomized Controlled Trial of Novel Dressing and Securement Techniques in 101 Pediatric Patients

Purpose To evaluate feasibility of an efficacy trial comparing peripherally inserted central catheter (PICC) dressing and securement techniques to prevent complications and failure. Materials and Methods This pilot, 3-armed, randomized controlled trial was undertaken at Royal Children's Hospital and Lady Cilento Children's Hospital, Brisbane, Australia, between April 2014 and September 2015. Pediatric participants (N = 101; age range, 0–18 y) were assigned to standard care (bordered polyurethane [BPU] dressing, sutureless securement device), tissue adhesive (TA) (plus BPU dressing), or integrated securement dressings (ISDs). Average PICC dwell time was 8.1 days (range, 0.2–27.7 d). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were PICC complications, dressing performance, and parent and staff satisfaction. Results Protocol feasibility was established. PICC failure was 6% (2/32) with standard care, 6% (2/31) with ISD, and 3% (1/32) with TA. PICC complications were 16% across all groups. TA provided immediate postoperative hemostasis, prolonging the first dressing change until 5.5 days compared with 3.5 days and 2.5 days with standard care and ISD respectively. Bleeding was the most common reason for first dressing change: standard care (n = 18; 75%), ISD (n = 11; 69%), TA (n = 4; 27%). Parental satisfaction (median 9.7/10; P =.006) and staff feedback (9.2/10; P =.002) were most positive for ISD. Conclusions This research suggests safety and acceptability of different securement dressings compared with standard care; securement dressings may also reduce dressing changes after insertion. Further research is required to confirm clinically cost-effective methods to prevent PICC failure

An implementation framework for the clinically indicated removal policy for peripheral intravenous catheters

Background: Equivalent clinical outcomes, lower costs, and fewer invasive procedures have resulted in revised recommendations for the removal of peripheral intravenous catheters (PIVCs) from the traditional 72- to 96-hourly removal to removal based upon clinical indication. Problem: Uptake of this evidence-based innovation to health systems is often delayed, in part due to the lack of a guiding framework for successful implementation strategies to guide systems to transition to and sustain clinically indicated PIVC removal. Approach: We used the Consolidated Framework for Implementation Research (CFIR) to reflect on strategies likely important for the successful implementation of PIVC removal evidence into policy and practice. Outcomes: We discuss and provide a critique of salient strategies for successful implementation of clinically indicated PIVC removal with regard to intervention characteristics, the outer and inner settings, characteristics of individuals, and implementation processes. Conclusions: Successful implementation of clinically indicated PIVC removal can be achieved through planned and systematic processes within the CFIR framework

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

The MIDLINE trial – managing intravenous devices among patients with limited vascular access or prolonged therapy: a pilot randomised control trial protocol

Introduction Peripheral intravenous catheters (PIVCs) are essential for administration of intravenous fluids and medications. While patient need for PIVCs is high, up to 69% fail due to complications such as occlusion and infiltration. Midline catheters (MCs) are an alternative to PIVCs; they are 8–20cms in length and terminate at, or are distal to, the axillary vein, not in the central venous circulation. Midline catheters’ rising popularity is due to concerns that patients’ veins are depleted by multiple consecutive PIVCs. However, there have been no randomised controlled trials (RCTs) comparing these devices to guide practice. Methods and analysis This single centre, parallel group, pilot RCT is designed to compare effectiveness of MCs with PIVCs for patients with difficult vascular access (≤2 visible and palpable veins) and/or receiving peripherally compatible intravenous therapy for ≥5 days. This trial will be conducted at the Royal Brisbane and Women’s Hospital, Australia. The recruitment target is 70 participants per group (n=140). There are three primary outcomes of interest to test: 1) Feasibility of an adequately powered RCT with pre-established criteria for eligibility, recruitment, protocol adherence and retention; 2) Insertion failure (number of PIVCs/MCs unable to be inserted); and 3) Post-insertion failure: all-cause failure. Secondary outcomes to be collected include: number of insertion attempts; time to insert; catheter dwell time; costs (staff time/equipment); patient-reported insertion pain; and individual causes of failure, e.g. phlebitis. Feasibility outcomes will be reported descriptively and analysed against pre-determined acceptability criteria. As a pilot study, statistical comparison methods will be tested. Cox regression will assess the effect of patient and treatment differences

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