Dr Tarja Karpanen University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK

Transcription

1 Dr Tarja Karpanen University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK

2 Background. CVC securement methods. Sutureless CVC securement system clinical evaluation.

3 CVC related infections decreasing: Evidence-based practices; Innovative technologies. However - CVC related infections still contribute a significant number of (preventable) infections. Guidelines for short-term CVC securement minimal.

4 Catheter Securement Devices: Recommendation Use a sutureless securement device to reduce the risk of infection for intravascular catheters [105]. Category II Ref. 105: Yamamoto AJ, Solomon JA, Soulen MC, et al. Sutureless securement device reduces complications of peripherally inserted central venous catheters. J Vasc Interv Radiol 2002; 13:77 81.

5 Sutureless securement devices avoid disruption around the catheter entry site and may decrease the degree of bacterial colonization. [105]. Using a sutureless securement device also mitigates the risk of sharps injury to the healthcare provider from inadvertent needlestick injury.

6 Randomized study (adult patients): PICC secured with sutures (n=85) or StatLock (n=85). Key findings: StatLock patient group: Fewer total PICC-related complications (49.4% vs 71.8%; p=ns); Catheter dislodgements (11.8% vs 14.1%; p=ns); Significantly fewer (confirmed) CR-BSI (1.2% vs. 9.4%; p=0.04). *Reference: Sutureless securement device reduces complications of peripherally inserted central venous catheters. J Vasc Interv Radiol 2002; 13:77 81.

7 Prevention of: Catheter displacement; Trauma to the blood vessel wall (& catheterrelated thrombus); CRBSI/ Introduction of microorganisms. Cost-effective; Easy/faster to apply, re-apply and remove; Prevent occlusions; Increase catheter dwell time (?); Ability to observe catheter insertion site; Patient comfort.

8 Sutures Staples Anchor device Tapes Dressings Catheter holders Tissue adhesives

9 GRIP-LOK Catheter Stabilization Device (for Securement of Arrow Howes CVC Catheters) SorbaView SHIELD, Centurion Medical Products GRIP-LOK 3601CVC for Universal CVC Securement Bard StatLock PICC Plus stabilization Device Centurion CVC Catheter Securement Anchor 3M PICC / CVC Securement System SecurAcath, Interrad Medical Inc.

10 Sutures Pro s Inexpensive Widely available Strong Knowhow (technique) Easy to manipulate Con s Risk of needlestick injury To-and-fro movement Discomfort to patient Staples Fast to apply Risk of CVC dislodgement Discomfort to patient Anchor device Easy to clean CVC site Comfortable to patient Cost Training

11 Catheter holders/dressings Tapes Tissue adhesives Pro s Comfortable to patient Fast to a apply/remove Comfortable to patient Fast to apply Comfortable to patient Fast to a apply/remove Durable Good tensile/mechanical strength Con s Cost Training Contra-indications Compatibility Variations in technique Difficult to remove from the dressing Loosening over time Poor shear strength Compatibility

12 Limited evidence from (peer-reviewed) randomized clinical studies on short-term CVC securement. Small scale studies/ clinical observations reported. Most evidence from PVC, arterial catheter and PICC securement.

13 18 publications reviewed, which included: Securement of PICC (6), CVC (6), A-line (4), haemodialysis (1), various (1) (PVC excluded); Catheter securement with: adhesives (5); tapes (4); staples (2); anchor device (2); sutureless securement devices (11). Variation in study outcomes/definition between the trials. Complication rates included: migration/dislodgement, infection, occlusion, leakage, central venous thrombosis.

14 The key points: tapes and staples performed worse than sutures; dressings complication rates varied between the studies; tissue adhesive more evidence needed however may be suitable for short duration; anchor device overall complication rate low however larger (RCT) studies needed; sutureless securement devices performed well against their comparator, however complication rates varied greatly between the studies.

15 Training/awareness/education; Staff resistance; Lack of multidisciplinary support; Safety concerns; Contra-indications for use; Compatibility with equipment. Reference: Griswold et al. Investigation of safety engineered device to prevent needlestick injury: why has not StatLock stuck? BMJ Open 2013

16 CVC Securement device feasibility study

17 CE-marked; on the market in the US since 2013, Consists of: moulded plastic device integrated onto a breathable base (with a silicone adhesive) and a soft cloth bordered transparent film dressing. Accommodates the majority of CVC catheters up to and including 12 F. Figure. Tegaderm I.V. Advanced Securement Device (left) and Advance Securement Dressing (right).

18 To evaluate the safety, comfort and usability of a 3M PICC/CVC securement device compared with the use of the currently utilized method of securement of a short-term CVC in critical care patients.

19 Multicentre, prospective, observational, randomized, non-blinded clinical evaluation.

20 University Hospitals Birmingham NHS Foundation Trust, BIRMINGHAM, UK (Prof Tom SJ Elliott) Bichat-Claude Bernard Hopital, PARIS, FRANCE (Prof Jean-Francois Timsit) Centre Hospitalier Universitaire, Universite de Poitiers et Inserm, POITIERS, FRANCE (Prof Olivier Mimoz) Hospital Universitari Arnau de Vilanova, LLEIDA, SPAIN (Dr Mercedes Palomar)

21 Primary: the performance characteristics of the securement devices (including CVC displacement and CVC related complications). Secondary: the performance of securement devices by clinical users.

22 Study outline 42 patients 14 patients IJ 14 patients SC 14 patients FEM 7 patients with A 7 patients with B 7 patients with A 7 patients with B 7 patients with A 7 patients with B Group A= sutures + Advance dressing Group B= CVC securement device + Advance dressing

23 18 years old; Admitted to a critical care unit; Require a single, short-term, non-cuffed, nontunnelled CVC ( 12F in size); Prospective patient/consultee consent.

24 Confused; Excessively perspiring; Non-adherent skin/ Condition affecting the skin integrity at the insertion site; Uncorrected bleeding diathesis; Allergy to adhesives/ device components; >1 catheter inserted at the same location.

25 Primary study endpoints: Total number of catheter dislodgements. Secondary study endpoints: Number of complete/ incomplete catheter dislodgements; Adherence onto skin/catheter; Number of unresolved occlusions.

26 Study endpoints: Number of catheters requiring immediate repositioning of securement device; Number of dressing changes per catheter; Catheter insertion site visible; Number of patients/ reasons for requiring an alternative catheter securement method; Clinical staff satisfaction; Patient comfort level.

27 Data collated from all four European centres (electronic database); Not powered to show statistical significant differences: A feasibility study Acceptability & Clinical performance

28 In the UK, Recruitment: commencing June Estimated study end date (recruitment): August 2015.

29 With appropriate training, sutureless securement systems may offer safe and effective alternative to suture securement. The choice of securement system should be evaluated for each patient, as contra-indications for each securement system applies. Larger studies on efficacy and safety of alternative CVC securement systems and their effect in reducing CRI are needed.

30 We would like to thank 3M Health Care (Neuss, Germany) for providing an educational grant to undertake the sutureless securement system evaluation.