Dataset Information

SecurAstaP trial: securement with SecurAcath versus StatLock for peripherally inserted central catheters, a randomised open trial.

ABSTRACT: OBJECTIVES:To assess the effect on needed nursing time for dressing change. DESIGN, SETTING, PARTICIPANTS:A parallel-group, open-label, randomised controlled trial in patients who are in need for a peripherally inserted central catheter insertion in one teaching hospital in Belgium. The follow-up lasted 180 days or until catheter removal, whatever came first. A computer generated table was used to allocate devices. Randomised patients were 105 adults (StatLock, n=53; SecurAcath, n=52) and primary analysis was based on all patients (n=92) with time measurements (StatLock, n=43; SecurAcath, n=49). INTERVENTIONS:StatLock which has to be changed weekly versus SecurAcath which could remain in place for the complete catheter dwell time. MAIN OUTCOME MEASURE:Needed time for the dressing change at each dressing change (SecurAcath) or at each dressing change combined with the change of the securement device (StatLock). RESULTS:Median time needed for dressing change was 7.3?min (95%?CI 6.4?min to 8.3?min) in the StatLock group and in the SecurAcath group 4.3?min (95%?CI 3.8 min to 4.9?min) (P<0.0001). The time in the SecurAcath group was reduced with 41% (95% CI 29% to 51%). Incidence rates of migration, dislodgement and catheter-related bloodstream infection were comparable across groups. Pain scores were higher with SecurAcath than with StatLock at insertion (P=0.02) and at removal (P<0.001) and comparable during dressing change (P=0.38) and during dwell time (P=0.995). User-friendliness was scored at insertion and removal. All statements regarding the user-friendliness were scored significantly higher for StatLock than for SecurAcath (P<0.05). Only for the statement regarding the recommending routine use of the device, which was asked at removal, no difference was found between the two devices (P=0.32). CONCLUSION:Use of SecurAcath saves time during dressing change compared with StatLock. Training on correct placement and removal of SecurAcath is critical to minimise pain. TRIAL REGISTRATION NUMBER:NCT02311127; Pre-results.

SUBMITTER: Goossens GA

PROVIDER: S-EPMC5855473 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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SecurAstaP trial: securement with SecurAcath versus StatLock for peripherally inserted central catheters, a randomised open trial.

Goossens Godelieve Alice GA Grumiaux Niel N Janssens Christel C Jérôme Martine M Fieuws Steffen S Moons Philip P Stas Marguerite M Maleux Geert G

BMJ open 20180224 2

<h4>Objectives</h4>To assess the effect on needed nursing time for dressing change.<h4>Design, setting, participants</h4>A parallel-group, open-label, randomised controlled trial in patients who are in need for a peripherally inserted central catheter insertion in one teaching hospital in Belgium. The follow-up lasted 180 days or until catheter removal, whatever came first. A computer generated table was used to allocate devices. Randomised patients were 105 adults (StatLock, n=53; SecurAcath, n ...[more]

PMID: 29478011

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Project description:Use of peripherally inserted central catheters has expanded rapidly, but the consequences for patients who eventually require hemodialysis are undefined.Our national, population-based analysis included 33,918 adult Medicare beneficiaries from the US Renal Data System who initiated hemodialysis with central venous catheters as their sole vascular access in 2010 and 2011. We used linked Medicare claims to identify peripherally inserted central catheter exposures and evaluate the associations of peripherally inserted central catheter placement with transition to working arteriovenous fistulas or grafts and patient survival using a Cox model with time-dependent variables.Among 33,918 individuals initiating hemodialysis with a catheter as sole access, 12.6% had received at least one peripherally inserted central catheter. Median follow-up was 404 days (interquartile range, 103-680 days). Among 6487 peripherally inserted central catheters placed, 3435 (53%) were placed within the 2 years before hemodialysis initiation, and 3052 (47%) were placed afterward. Multiple peripherally inserted central catheters were placed in 30% of patients exposed to peripherally inserted central catheters. Recipients of peripherally inserted central catheters were more likely to be women and have comorbid diagnoses and less likely to have received predialysis nephrology care. After adjustment for clinical and demographic factors, peripherally inserted central catheters placed before or after hemodialysis initiation were independently associated with lower likelihoods of transition to any working fistula or graft (hazard ratio for prehemodialysis peripherally inserted central catheter, 0.85; 95% confidence interval, 0.79 to 0.91; hazard ratio for posthemodialysis peripherally inserted central catheter, 0.81; 95% confidence interval, 0.73 to 0.89).Peripherally inserted central catheter placement was common and associated with adverse vascular access outcomes. Recognition of potential long-term adverse consequences of peripherally inserted central catheters is essential for clinicians caring for patients with CKD.

Project description: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.

Dataset Information

SecurAstaP trial: securement with SecurAcath versus StatLock for peripherally inserted central catheters, a randomised open trial.

Publications

SecurAstaP trial: securement with SecurAcath versus StatLock for peripherally inserted central catheters, a randomised open trial.

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