Search

Introduction: Peripheral intravenous catheters (PIVCs) are the most commonly used vascular access device in hospitalised patients. Yet PIVCs may be complicated by local or systemic infections leading to increased healthcare costs. Chlorhexidine gluconate (CHG)-impregnated dressings may help reduce PIVC-related infectious complications but have not yet been evaluated. We hypothesise an impregnated CHG transparent dressing, in comparison to standard polyurethane dressing, will be safe, effective and cost-effective in protecting against PIVC-related infectious complications and phlebitis., Methods and Analysis: The ProP trial is a multicentre, superiority, randomised clinical and cost-effectiveness trial with internal pilot, conducted across three centres in Australia and France. Patients (adults and children aged ≥6 years) requiring one PIVC for ≥48 hours are eligible. We will exclude patients with emergent PIVCs, known CHG allergy, skin injury at site of insertion or previous trial enrolment. Patients will be randomised to 3M Tegaderm Antimicrobial IV Advanced Securement dressing or standard care group. For the internal pilot, 300 patients will be enrolled to test protocol feasibility (eligibility, recruitment, retention, protocol fidelity, missing data and satisfaction of participants and staff), primary endpoint for internal pilot, assessed by independent data safety monitoring committee. Clinical outcomes will not be reviewed. Following feasibility assessment, the remaining 2624 (1312 per trial arm) patients will be enrolled following the same methods. The primary endpoint is a composite of catheter-related infectious complications and phlebitis. Recruitment began on 3 May 2023., Ethics and Dissemination: The protocol was approved by Ouest I ethic committee in France and by The Queensland Children's Hospital Human Research Ethics Committee in Australia. The findings will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals., Trial Registration Number: NCT05741866., Competing Interests: Competing interests: CMR’s employer (The University of Queensland or Griffith University) has received unrestricted research grants on her behalf from BD, Cardinal Health, Eloquest and consultancy payments from 3M, BD, BBraun, and ITL Biomedical. AU’s employer (The University of Queensland or Griffith University) has received unrestricted research grants or consultancies on her behalf from BD, 3M, Sterile Care and Medline. NMM— Griffith University and The University of Queensland have received on her behalf investigator-initiated research grants or consultancies from Cardinal Health, 3M, Eloquest, Medline and Becton Dickinson. AC has received unrestricted investigator-initiated research grants, paid to her employer (Griffith University), from Cardinal Health, 3 M and Eloquest. TMK’s employer (The University of Queensland or Griffith University) has received unrestricted research grants on her behalf from BD, and consultancy payments from 3M, BD, BBraun, Medical Specialties Australia, and Smiths Medical. OM, BD and JG received funding for congress attendance, and research funding from Becton Dickinson and 3M. JB’s employer (Griffith University) has received unrestricted research grants on his behalf from BD and Navi Technologies, and consultancy payments from 3M, and BD. COB has no conflicts of interest., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Rates of unused ( ' idle') peripheral intravenous catheters (PIVCs) are high but can vary per setting. Understanding factors that influence the decision-making of doctors, nurses and paramedics in the emergency setting regarding PIVC insertion, and what factors may modify their decision is essential to identify opportunities to reduce unnecessary cannulations and improve patient-centred outcomes. This study aimed to understand factors associated with clinicians' decision-making on whether to insert or use a PIVC in the emergency care setting., Design: A qualitative descriptive study using in-depth semistructured interviews and thematic analysis., Setting: Gold Coast, Queensland, Australia, in a large tertiary level emergency department (ED) and local government ambulance service., Participants: Participants recruited were ED clinicians (doctors, nurses) and paramedics who regularly insert PIVCs., Results: From the 15 clinicians interviewed 4 key themes: knowledge and experience, complicated and multifactorial , convenience, anticipated patient clinical course, and several subthemes emerged relating to clinician decision-making across all disciplines. The first two themes focused on decision-making to gather data and evidence, such as knowledge and experience , and decisions being complicated and multifactorial . The remaining two themes related to the actions clinicians took such as convenience and anticipated patient clinical course ., Conclusion: The decision to insert a PIVC is more complicated than clinicians, administrators and policy-makers may realise. When explored, clinician decisions were multifaceted with many factors influencing the decision to insert a PIVC. In actual practice, clinicians routinely insert PIVCs in most patients as a learnt reflex with little cognitive input. When considering PIVC insertion, more time needs to be devoted to the awareness of: (1) decision-making in the context of the clinician's own experience, (2) cognitive biases and (3) patient-centred factors. Such awareness will support an appropriate risk assessment which will benefit the patient, clinician and healthcare system., Competing Interests: Competing interests: NMM reports investigator-initiated research grants and speaker fees provided to Griffith University from vascular access product manufacturers (Becton Dickinson, 3M, Eloquest Healthcare and Cardinal Health); and a consultancy payment for expert advice from Becton Dickinson. CMR discloses that her current or previous employers have received funding on her behalf in the form of investigator initiated research grants from BD-Bard, Cardinal Health, and Eloquest Healthcare as well as consultancy payments from 3M and BD Bard. All other authors declare that they have no competing interests., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Peripherally inserted central catheters (PICCs) are vital for the delivery of medical therapies, but up to 30% of PICCs are associated with complications such as deep vein thrombosis or infection. The integration of antimicrobial and hydrophobic catheter materials, and pressure-activated valves, into polyurethane PICCs are innovations designed to prevent infective and/or thrombotic complications., Methods and Analysis: A multicentre, parallel group, superiority randomised controlled trial with two experimental arms ((1) hydrophobic PICC (with pressure-activated valve); (2) chlorhexidine gluconate-impregnated PICC (with external clamp)) and one control group ((3) conventional polyurethane PICC (with external clamp)). Recruitment of 1098 adult and paediatric patients will take place over 2 years at three tertiary-referral hospitals in Queensland, Australia. Patients are eligible for inclusion if their PICC is to be inserted for medical treatment, with a vascular size sufficient to support a 4-Fr PICC or larger, and with informed consent. The primary outcome is PICC failure , a composite of thrombotic (venous thrombosis, breakage and occlusion) and infective complications (PICC-associated bloodstream infection and local infection). Secondary outcomes include: all-cause PICC complication; thrombotic complications; infective complications; adverse events (local or systemic reaction); PICC dwell time; patient/parent satisfaction; and healthcare costs. Differences between both intervention groups and the control group will be compared using Cox proportional hazards regression. Effect estimates will be presented as HRs with corresponding 95% CI., Ethics and Dissemination: Ethical approval from Queensland Health (HREC/QCHQ/48682) and Griffith University (Ref. No. 2019/094). Results will be published., Trial Registration Number: ACTRN12619000022167., Competing Interests: Competing interests: Griffith University (AJU's former employer) has received unrestricted research and educational grants to support her research (unrelated from the current project) from 3M, Becton Dickinson and Cardinal Health. Griffith University (DA’s employer) has received consultancy payments for educational lectures based on her research and clinical expertise from 3M and Johnsons and Johnsons. Griffith University (TK’s employer) has received unrestricted research and educational grants from 3M, Becton Dickinson and Medical Specialties Australasia. Griffith University (RMW’s employer) has received unrestricted research and educational grants to support her research (unrelated to current project) from Becton Dickinson. Griffith University (NMM's former employer) has received unrestricted research and educational grants to support her research (unrelated from the current project) from 3M, Becton Dickinson and Cardinal Health. Griffith University (AB's employer) has received consultancy payments from Becton Dickinson (unrelated to the current project). Griffith University (JB’s employer) has received unrestricted research and educational grants to support her research (unrelated to current project) from Becton Dickinson, and Navi Technologies. PM is a member of Myeloma Advisory Boards for Celgene, Janssen, Amgen, Takeda and Amyloidosis Advisory Boards for Pfizer and Caelum. No personal fees have been received for these services. PM’s has received a research grant from Janssen for a clinical trial. PM has accommodation and registration provided by Amgen for attendance at the International Myeloma Workshop in 2019. Griffith University (CMR's former employer) has received unrestricted research and educational grants to support her research (unrelated to the current project) from 3M, Becton Dickinson and Cardinal Health. Other authors have no conflicts of interests to disclose., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Peripheral intravenous catheters (PIVCs) are frequently used in hospitals. However, PIVC complications are common, with failures leading to treatment delays, additional procedures, patient pain and discomfort, increased clinician workload and substantially increased healthcare costs. Recent evidence suggests integrated PIVC systems may be more effective than traditional non-integrated PIVC systems in reducing phlebitis, infiltration and costs and increasing functional dwell time. The study aim is to determine the efficacy, cost-utility and acceptability to patients and professionals of an integrated PIVC system compared with a non-integrated PIVC system., Methods and Analysis: Two-arm, multicentre, randomised controlled superiority trial of integrated versus non-integrated PIVC systems to compare effectiveness on clinical and economic outcomes. Recruitment of 1560 patients over 2 years, with randomisation by a centralised service ensuring allocation concealment. Primary outcomes: catheter failure (composite endpoint) for reasons of: occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, localised or catheter-associated bloodstream infections., Secondary Outcomes: first time insertion success, types of PIVC failure, device colonisation, insertion pain, functional dwell time, adverse events, mortality, cost-utility and consumer acceptability. One PIVC per patient will be included, with intention-to-treat analysis. Baseline group comparisons will be made for potentially clinically important confounders. The proportional hazards assumption will be checked, and Cox regression will test the effect of group, patient, device and clinical variables on failure. An as-treated analysis will assess the effect of protocol violations. Kaplan-Meier survival curves with log-rank tests will compare failure by group over time. Secondary endpoints will be compared between groups using parametric/non-parametric techniques., Ethics and Dissemination: Ethical approval from the Royal Brisbane and Women's Hospital Human Research Ethics Committee (HREC/16/QRBW/527), Griffith University Human Research Ethics Committee (Ref No. 2017/002) and the South Metropolitan Health Services Human Research Ethics Committee (Ref No. 2016-239). Results will be published in peer-reviewed journals., Trial Registration Number: ACTRN12617000089336., Competing Interests: Competing interests: MIC’s employer has received on her behalf: an unrestricted research grant from BD, during the conduct of the study. EL’s employer has received on her behalf: a consultancy payment from 3M, outside the submitted work. MC’s employer has received on her behalf: an unrestricted research grant from BD, during the conduct of the study; unrestricted research grants and/or educational grants from 3M, Baxter, BD, Entrotech, outside the submitted work. NMM’s employer has received on her behalf: an unrestricted research grant from BD, during the conduct of the study; unrestricted research grants and/or educational grants from BD, Hospira and Adhezion, outside the submitted work; consultancy payments from BD and Hospira, outside the submitted work. MCW’s employer has received on her behalf: an unrestricted research grant from BD, during the conduct of the study; unrestricted research grants and/or educational grants from BD, outside the submitted work; consultancy payments from BD, outside the submitted work. PJJC’s employer has received on his behalf: an unrestricted research grant from BD, during the conduct of the study. LZ’ employer has received on her behalf: an unrestricted research grant from BD, during the conduct of the study; unrestricted research grants and/or educational grants from BD, outside the submitted work. GJ’s employer has received on his behalf: an unrestricted research grant from BD. CMR’s employer has received on her behalf: an unrestricted research grant from BD, during the conduct of the study; unrestricted research grants and/or educational grants from 3M, Adhezion, Angiodynamics, Bard, Baxter, BBraun, BD, Carefusion, Centurion Medical Products, Cook Medical, Entrotech, Flomedical, ICU Medical, Medical Australia, Medtronic, Smiths Medical, Teleflex, outside the submitted work; consultancy payments from 3M, Bard, BBraun, BD, Smiths Medical, ResQDevices, outside the submitted work. No commercial entity had any role in the preparation of this manuscript., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

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., Competing Interests: Competing interests: CMR’s employer has received on her behalf: unrestricted research and educational grants from: 3M, Adhezion, Angiodynamics, Bard, Baxter, BBraun, BD, Carefusion, Centurion Medical Products, Cook Medical, Entrotech, Flomedical, ICU Medical, Medical Australia, Medtronic, Smiths Medical, Teleflex; consultancies payments for educational lectures from 3M, Bard, BBraun, BD,Carefusion and Mayo, and expert reports from BD, ResQDevices and Smiths Medical. NM’s employer has received on her behalf: consultancy payments for educational lectures based on her research from Hospira and BD, and unrestricted research grants from Adhezion and BD. JW: Nil. NG’s employer has received on her behalf: unrestricted research grants from Baxter. RC’s employer has received on his behalf: unrestricted research and educational grants from: StratPHARMA. ALM: Nil. PM’s employer has received on his behalf: research grants from Celgene, Janssen and Hospira. PM is a member of Advisory Boards for Celgene, Janssen, Amgen and BMS. PM has received consultancy payments from Celgene and Amgen. AU’s employer has received on her behalf: unrestricted research and educational grants from Adhezion, Angiodynamics, 3M, Carefusion, Centurion Medical Products and BBraun; consultancy payments for educational lectures based on her research from 3M and BD. TK’s employer has received on her behalf: unrestricted research and educational grants from 3M, Angiodynamics, Centurion Medical Products and Baxter; consultancy payments for educational lectures from Angiodynamics and BD VC: Nil. LZ’s employer has received on her behalf: an unrestricted research grant from BD. MM: Nil. EL: Nil. MAC: Nil. SK’s employer has on her behalf received consultancy payments for educational lectures and unrestricted research grants from BD. EA’s employer has received on his behalf: unrestricted research and educational grants from: 3M, BD, Carefusion, Cook Medical, Flo Medical. Consultancy payments for educational lectures based on his research and clinical expertise from 3M, BD, Carefusion, Teleflex, Cook Medical and Flo Medical. DM: Nil. MCM: Nil. DP: Nil. MC’s employer has received on her behalf: unrestricted research and educational grants from BD, Baxter, 3M and Entrotech. GRB’s employer has received on her behalf: unrestricted research grants from 3M, BBraun and BD/Carefusion. Consultancy payments for educational lectures based on her research from Becton Dickinson and ResQDevices. MIC: Nil. AH: Nil. AC: Nil. EGP: Nil. No commercial entity had any role in the conception, design or funding of this study, or in the preparation of this manuscript., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Vascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3-4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload., Methods and Analysis: This is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VAD-related bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, all-cause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant., Ethics and Dissemination: Relevant ethical approvals have been received. CONSORT Statement recommendations will be used to guide preparation of any publication. Results will be presented at relevant conferences and sent to the major organisations with clinical practice guidelines for VAD care., Trial Registration Number: Australian New Zealand Clinical Trial Registry (ACTRN 12610000505000)., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)