Marion L Mitchell1, Amanda J Ullman2, Mari Takashima2, Chelsea Davis3, Gabor Mihala4, Madeleine Powell3, Victoria Gibson5, Li Zhang5, Michelle Bauer6, E Geoffrey Playford7, Claire M Rickard8. 1. Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia; School of Nursing and Midwifery, Griffith University, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia. Electronic address: marion.mitchell@griffith.edu.au. 2. Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia; School of Nursing and Midwifery, Griffith University, Brisbane, Queensland, Australia. 3. Intensive Care Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia. 4. Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia; Centre for Applied Health Economics, Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia; School of Medicine, Griffith University, Nathan, Queensland, Australia. 5. Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia. 6. University of Queensland Centre for Clinical Research, Herston, Queensland, Australia. 7. Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia; Infection Management Services, Princess Alexandra Hospital, Brisbane, Queensland, Australia. 8. Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia; School of Nursing and Midwifery, Griffith University, Brisbane, Queensland, Australia; Visiting Scholar, Nursing Professional Development Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia.
Abstract
INTRODUCTION:Central venous access devices (CVADs) are a vital medical device for intensive care (ICU) patients; however, complications and failure are common, yet potentially prevented through effective dressings and securement. OBJECTIVES/AIMS: The objective of this study was to test the feasibility of a randomised controlled trial (RCT) comparing standard care with three dressing and securement products to prevent CVAD failure. Secondary aims included comparing dressing and securement products on CVAD failure, microbial colonisation, and intervention costs. METHODS: A single-centre pilot RCT of ICU adult patients requiring CVADs for >24 h were randomised to four groups: (i) sutures plus chlorhexidine gluconate (CHG) dressing (standard care); (ii) standard care plus tissue adhesive (TA); (iii) two sutureless stabilisation devices (SSD) plus CHG dressing; (iv) sutures, CHG disc plus integrated securement dressing (ISD). Descriptive statistics assessed feasibility. Incidence rates (IRs) of CVAD failure were reported, with group differences compared using the Fisher exact and log-rank tests. Cox regression explored univariable risks for failure. A substudy examined bacterial colonisation of catheter tips, dressings, and skin. Cost estimates of the intervention were compared. RESULTS:A total of 121 participants were randomised. Study feasibility was established with no withdrawal and moderate staff acceptability; however, recruitment was low at 12%. Overall CVAD failure was seen in 14 of 114 (12%) CVADs (19 per 1000 catheter-days); highest in the SSD group (IR: 27.3 per 1000 catheter-days [95% confidence interval {CI}: 11.4-65.6]), followed by the standard care group (IR: 22.3 per 1000 catheter-days [95% CI: 8.38-59.5]) and TA group (IR: 20.6 per 1000 catheter-days [95% CI: 6.66-64.0]), and lowest in the ISD group (IR: 8.8 per 1000 catheter-days [95% CI: 2.19-35.0]). The majority of complications (11/14, 79%) were suspected central line-associated bloodstream infection (CLABSI), of which only one was laboratory confirmed (standard care group). The cost per patient was lowest in the standard care group by an average difference of AUD $14. CONCLUSION(S): A large multisite RCT examining forms of securement and dressing is feasible. ISD is the highest priority to test further as it had the lowest failure rate. TRIAL REGISTRATION: ACTRN12615000667516 PROTOCOL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 368765.
RCT Entities:
INTRODUCTION: Central venous access devices (CVADs) are a vital medical device for intensive care (ICU) patients; however, complications and failure are common, yet potentially prevented through effective dressings and securement. OBJECTIVES/AIMS: The objective of this study was to test the feasibility of a randomised controlled trial (RCT) comparing standard care with three dressing and securement products to prevent CVAD failure. Secondary aims included comparing dressing and securement products on CVAD failure, microbial colonisation, and intervention costs. METHODS: A single-centre pilot RCT of ICU adult patients requiring CVADs for >24 h were randomised to four groups: (i) sutures plus chlorhexidine gluconate (CHG) dressing (standard care); (ii) standard care plus tissue adhesive (TA); (iii) two sutureless stabilisation devices (SSD) plus CHG dressing; (iv) sutures, CHG disc plus integrated securement dressing (ISD). Descriptive statistics assessed feasibility. Incidence rates (IRs) of CVAD failure were reported, with group differences compared using the Fisher exact and log-rank tests. Cox regression explored univariable risks for failure. A substudy examined bacterial colonisation of catheter tips, dressings, and skin. Cost estimates of the intervention were compared. RESULTS: A total of 121 participants were randomised. Study feasibility was established with no withdrawal and moderate staff acceptability; however, recruitment was low at 12%. Overall CVAD failure was seen in 14 of 114 (12%) CVADs (19 per 1000 catheter-days); highest in the SSD group (IR: 27.3 per 1000 catheter-days [95% confidence interval {CI}: 11.4-65.6]), followed by the standard care group (IR: 22.3 per 1000 catheter-days [95% CI: 8.38-59.5]) and TA group (IR: 20.6 per 1000 catheter-days [95% CI: 6.66-64.0]), and lowest in the ISD group (IR: 8.8 per 1000 catheter-days [95% CI: 2.19-35.0]). The majority of complications (11/14, 79%) were suspected central line-associated bloodstream infection (CLABSI), of which only one was laboratory confirmed (standard care group). The cost per patient was lowest in the standard care group by an average difference of AUD $14. CONCLUSION(S): A large multisite RCT examining forms of securement and dressing is feasible. ISD is the highest priority to test further as it had the lowest failure rate. TRIAL REGISTRATION: ACTRN12615000667516 PROTOCOL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 368765.