Controlling peripheral intravenous catheter failure by needleless connector design: A pilot randomised controlled trial.

AIM: To test the feasibility of a study protocol that compared the efficacy of neutral- and negative-pressure needleless connectors (NCs). DESIGN: A single-centre, parallel-group, pilot randomised control trial. METHODS: Our study compared neutral-(intervention) and negative-pressure (control) NCs among adult patients in an Australian hospital. The primary feasibility outcome was measured against predetermined criteria (e.g. eligibility, attrition). The primary efficacy outcome was all-cause peripheral intravenous catheter failure, analysed as time-to-event data. RESULTS: In total, 201 (100 control; 101 intervention) participants were enrolled between March 2020 and September 2020. All feasibility criteria were met except eligibility, which was lower (78%) than the 90% criterion. All-cause peripheral intravenous catheter failure was significantly higher in the intervention group (39%) compared to control (19%). CONCLUSION: With minor modifications to participant screening for eligibility, this randomised control trial is feasible for a large multicentre randomised control trial. The neutral NC was associated with an increased risk of peripheral intravenous catheter failure. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: There are several NC designs available, often identified by their mechanism of pressure (positive, negative and neutral). However, NCs can contribute to peripheral intravenous catheter failure. This is the first randomised controlled trial to compare neutral and negative NC designs. Negative pressure NCs had lower PIVC failure compared to neutral NCs, however the results might not be generalisable to other brands or treatment settings. Further high-quality research is needed to explore NC design. REPORTING METHOD: Study methods and results reported in adherence to the CONSORT Statement. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Does longer peripheral intravenous catheter length optimise antimicrobial delivery? Protocol for the LEADER study.

BACKGROUND: Hospitalised patients receiving intravenous antimicrobial therapy require a reliable device through which this is delivered. Short peripheral intravenous catheters (PIVCs) are the default device for antimicrobial therapy but up to half fail before therapy completion, leading to suboptimal drug dosing, patient distress from repeated insertions, and increased healthcare costs. This study will investigate the use of long PIVCs to determine if they are more reliable at delivering antimicrobial therapy. METHODS: A two-arm, parallel randomised controlled trial of hospitalised adults requiring at least 3 days of peripherally compatible intravenous antimicrobials. Participants will be randomised to a short (<4 cm) or long (4.5-6.4 cm) PIVC. After interim analysis ( n=70) for feasibility and safety, 192 participants will be recruited. Primary outcome is disruption to antimicrobial administration from all-cause PIVC failure. Secondary outcomes include: number of devices to complete therapy, patient-reported pain and satisfaction, and a cost analysis. Ethical and regulatory approvals have been received.

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.

'How many audits do you really need?': Learnings from 5-years of peripheral intravenous catheter audits.

BACKGROUND: Peripheral intravenous catheters (PIVCs) are medical devices used to administer intravenous therapy but can be complicated by soft tissue or bloodstream infection. Monitoring PIVC safety and quality through clinical auditing supports quality infection prevention however is labour intensive. We sought to determine the optimal patient 'number' for clinical audits to inform evidence-based surveillance. METHODS: We studied a dataset of cross-sectional PIVC clinical audits collected over five years (2015-2019) in a large Australian metropolitan hospital. Audits included adult medical, surgical, women's, cancer, emergency and critical care patients, with audit sizes of 69-220 PIVCs. The primary outcome was PIVC complications for one or more patient reported symptom/auditor observed sign of infection or other complications. Complication prevalence and 95% confidence interval (CI) were calculated. We modelled scenarios of low (10%), medium (20%) and high (50%) prevalence estimates against audit sizes of 20, 50, 100, 150, 200, 250, and 300. This was used to develop a decision-making tool to guide audit size. RESULTS: Of 2274 PIVCs evaluated, 475 (21%) had a complication. Complication prevalence per round varied from 7.8% (95% CI, 4.2-12.9) to 39% (95% CI, 32.0-46.4). Precision improved with larger audit size and lower complication rates. However, precision was not meaningfully improved by auditing >150 patients at a complication rate of 20% (95% CI 13.9%-27.3%), nor >200 patients at a complication rate of 50% (95% CI 42.9%-57.1%). CONCLUSION: Audit sizes should be 100 to 250 PIVCs per audit round depending on complication prevalence.

Securement methods for peripheral venous catheters to prevent failure: a randomised controlled pilot trial.

PURPOSE: To assess the effectiveness of four securement methods to prevent peripheral intravenous catheter (PIVC) failure. METHODS: A single-centre, four-arm, randomised, controlled, non-blinded, superiority pilot trial was conducted in a tertiary referral hospital in Queensland (Australia), between November 2012 and January 2013. Adult patients, with a PIVC expected to remain in situ for ≥24 hours and admitted to general medical or surgical wards, were randomly allocated to standard polyurethane dressing (control, SPU), tissue adhesive (TA) with an SPU, bordered polyurethane dressing (BPU) or sutureless securement device (SSD) with an SPU, experimental groups. The primary endpoint was PIVC failure, defined as premature device removal before the end of therapy because of pain, blockage, leaking, accidental removal and local or catheter-related bloodstream infection. RESULTS: PIVCs were used for an average of 2.6 days across all study groups (n = 85). Catheter failure was lowest in the TA group (3/21, 14%) and highest in the control group (8/21, 38%), with BPU and SSD failure at 5/20 (25%) and 5/23 (22%), respectively. The adjusted hazard ratio of catheter failure was lowest in the TA group (0.50, 95% CI: 0.13-1.98), and then the BPU (0.52, 95% CI: 0.15-1.78) and SSD (0.61, 95% CI: 0.20-1.91) groups. No patient was suspected of a local or catheter-related bloodstream infection. CONCLUSIONS: Current SPU dressings alone do not prevent many cases of PIVC failure. TA appears promising as an innovative solution, but may not be suitable for all patients. A larger Australian National Health and Medical Research Council (NHMRC)-funded trial has commenced.

Intravascular device use, management, documentation and complications: a point prevalence survey.

OBJECTIVE: To examine the use, management, documentation and complications for intravascular devices in cardiac, medical and surgical inpatients. METHODS: A point prevalence survey was undertaken in a large tertiary hospital in Queensland. Descriptive statistics were used to analyse data. RESULTS: Of the 327 patients assessed, 192 (58.7%) had one or more devices in situ. Of the 220 devices, 190 (86.4%) were peripheral venous catheters, 25 (11.4%) were peripherally inserted central catheters and five (2.3%) were central venous catheters. Sixty-two of 220 devices (28.2%) were in situ without a clear purpose, whereas 54 (24.7%) had one or more complications, such as redness, pain, tracking, oedema or oozing. There was no documentation on the daily patient care record to indicate that a site assessment had occurred within the past 8h for 25% of the devices in situ. CONCLUSIONS: The present study identified several problems and highlighted areas for improvement in the management and documentation for intravascular devices. Ongoing education, promoting good clinical practice and reauditing, can be applied to improve the management of devices.