Securement of Peripheral Intravenous Catheters (PIV) Nicole Marsh

Transcription

1 Securement of Peripheral Intravenous Catheters (PIV) Nicole Marsh

2 Disclosure AVATAR research is supported by competitive government, university, hospital and professional organisation research grants as well as industry unrestricted donations, investigator initiated research/educational grants and occasional consultancy payments from the following companies: -3M, Angiodynamics, Baxter, BBraun, BD, Carefusion, Centurion, Cook, Entrotech, Hospira, Smiths, Teleflex, Vygon This presentation is independently prepared and reflects no commercial entity nor promotes particular products unless these are supported by research data Sources of funding for each particular research study will be disclosed throughout this presentation

3 Peripheral intravenous catheter failure within the adult population: a systematic review Purpose: To systematically review, summarize and quantify PIV failure and individual catheter-related complications. Searches: The Cochrane Register of Controlled Trials, PubMed, CINAHL, and EMBASE (2000 to October 2017) Study Selection: Observational studies and randomised controlled trials A total of 92 studies, 64 observational studies and 28 randomised controlled trials (75,433 PIVs).

4 PIVs are failing around the globe 32% 41% 25% 61% 35%

5 PIVs are failing around the globe Worldwide 25% 36%

6 Phlebitis 21% 7% 30% 18% 8%

7 Phlebitis Worldwide 25% 16%

8 PIVs are failing around the globe Event Studies (PIVs) Pooled % Infiltration 40 (24,919) 12% Occlusion 31 (32,672) 8% Pain 23 (18,070) 7% Leakage 17 (9,339) 7% Dislodgment 36 (18,425) 6% CRBSI 12 (14,954) <0.1% Local infection 11 (13,884) 0.7%

9 PIVs are failing around the globe Event Studies (PIVs) Pooled % Infiltration 40 (24,919) 12% Occlusion 31 (32,672) 8% Pain 23 (18,070) 7% Leakage 17 (9,339) 7% CRBSI <0.1 ( ) per 1000 catheter days (6 Dislodgment 36 (18,425) 6% studies) CRBSI 12 (14,954) <0.1% Local infection 11 (13,884) 0.7%

10 Why are PIVs failing?

11 PIVs 25% medical/surgical patients had one or more complications (e.g. redness, pain, tracking, swelling) Cancer Care had 50% of PVCs with one or more complications 25% device dressings were NOT clean, dry and intact Greater than 80% of PIVs had non-sterile tape over the insertion site Seven different primary dressings & securements in use

12 randomized controlled trials patients studied Risk of bias assessed Meta-analysis 4 Comparisons 1. Transparent PU Vs Gauze + Tape (2 studies) 2. Transparent PU Vs Sticking Plaster (1 study) 3. Bordered Transparent Vs Securement Device (1 study) 4. Bordered Transparent Vs Tape (1 study) More, high quality research is needed 12 of 25

13 The ideal PIV dressing? Sutureless securement device (SSD) Integrated securement dressings CHG dressings Tissue adhesive

14 In a dream world a PIV dressing & securement device/s would. Be antimicrobial Breathe Be comfortable Be easy to use Prevent micro-motion Cover the wound Prevent / contain ooze Hold PIV in place Be transparent Be affordable

15 AVATAR PIV Studies 1. RCT of 4 different PIV dressings and securements (Rickard 2018) 2. Prospective Observational study of PIVs (Marsh 2017) 3. RCT comparing an integrated PIV dressing and a bordered transparent dressing (Marsh 2018)

16 1. Securing All Vascular access devices Effectively Simple Transparent PU Bordered Transparent PU Adhesive Securement Device Tissue Adhesive The SAVE Trial

17 Multi-centre, 4-arm parallel, superiority RCT AUD$1 Million National Health & Medical Research Council Recruitment March Sept ,709 patients randomized to 4 groups Accepted LANCET (Rickard et.al. 2018)

18 The SAVE Trial Primary outcome: PIV Failure PIV Failure SPU controls N=422 BPU N=423 SSD N=425 TA N=427 43% 40% 41% 38% p value Per/100 PIV days p value

19 The SAVE Trial Sensitivity analysis PIV Failure (N=1100) SPU controls N=250 BPU N=273 SSD N=296 TA N=281 PIV Failure 34% 35% 34% 26% p value Relative risk (95% CI) HR 1 10 ( ) HR 0 91 ( ) HR 0.88 ( ) P value

20 The SAVE Trial Secondary outcomes: SPU BPU SSD TA Occlusion 22% 19% 23% 16% P=0.027 Phlebitis 27% 22% 26% 25% P=0.027 Dislodgment 10% 9% 9% 7% PIV related bloodstream infection Local PIV infection

21 The SAVE Trial Bordered Polyurethane dressing Lowest rate of phlebitis Lowest rate of rash and bruising No skin tears Lowest product cost of the intervention arms Sutureless securement device Lowest rate of PIV colonization Staff survey gave it the highest score for acceptability and performance

22 TA (Glue) Why does it seem to work? Creates a: Securement Catheter Immediate, direct bond at the entry point and under the hub/wings Reduces motion, micromotion & internal vein trauma Primary action is against occlusion, then dislodgement What are the challenges? Not intuitive for inexperienced users Excess product in vial Application time longer Cost prohibitive Removal requires second product & longer time Various formulations exist

23 Many patients had numerous additional tapes, dressings, tubular bandages in ALL study groups We needed to dig deeper

24 2. REPLACE Study Journal of Hospital Medicine (2018)

25 REPLACE Study 1000 patients/ 1578 PVCs Data collection between October 2014 and December 2015 Recruitment was in the medical/surgical wards and maternity services Patients were recruited within 24 hours on PVC insertion All PIVs for the admission followed Research Nurse visited every 2 days Hospital had 72 hour removal policy (but frequent exclusions) Funding: Griffith University and a BD unrestricted grant-in-aid.

26 REPLACE Study Data collected Patient factors Characteristics N (%) Average age 54 years (mean) Males 546 (55) Surgical patients 673 (67) Co-morbidities (46%) Obese (BMI>30) 334 (33%) Infection 107 (11) Wound 502 (50)

27 Dressing factors REPLACE Study Data collected Dressing Characteristics N (%) Bordered dressing 496 (44) Simple transparent dressing 453 (40) Additional non-sterile tape 758 (48) Elasticised tubular bandage 260 (17)

28 REPLACE Study PIV Outcomes 29% failure (120/1000 days) 17% phlebitis (1 or more criteria) 14% occlusion/infiltration 10% accidental removal

29 REPLACE Study Final Model Dressing factors Securement (ever) Occlusion / infiltration Phlebitis Dislodgement Non-sterile tape # 0.44 Elastic tube bandage 0.49 Other securement All p<0.01 except # p<0.05

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31 3. Secure My Intravenous Line Effectively Marsh N, Larsen E, Genzel J, Mihala G, Ullman A, Kleidon T, Rickard CM Standard Care Integrated Securement Dressing SMILE Trial

32 SMILE Trial Objective Test the feasibility of an randomized trial Identify clinical and cost-effective methods to prevent failure To compare usual care dressings with novel methods Evaluate the acceptability of these devices to patients and health professionals Study adverse effect profiles Funding: Centurion Medical Products unrestricted grant-in-aid.

33 SMILE Trial Data collected Patient factors Characteristics Control N (%) Integrated dressing N (%) Average age (mean) 60 years 62 years Males 88 (59) 98 (65) Surgical patients 108 (72) 107 (72) Co-morbidities (71) 124 (82) Obese (BMI>30) 69 (46) 71 (49) Poor skin integrity 14 (9) 13 (9) Infection at baseline 37 (25) 43 (29) Wound at baseline 72 (48) 80 (53)

34 SMILE Trial Data collected PIV factors PIV Characteristics Control N (%) Intervention N (%) Device Size 20 g 86 (57) 80 (53) Placement in forearm 95 (76) 106 (71) Multiple insertion attempts 19 (31) 25 (17) Difficult insertion 56 (37) 56 (37) Site clipped 82 (55) 79 (53)

35 SMILE Trial Data collected Dressing Characteristics Dressing factors Control N (%) Integrated dressing N (%) Number of dressings used Dressing clean, dry and intact 90 (60) 124 (82) Additional tubular elasticised bandage or bandage 26 (17) 27 (18) Additional non-sterile tape 11 (7) 15 (10)

36 SMILE Trial Results Control N Integrated dressing N Device failure 46 (31%) 44 (29%) Dwell time in hours

37 SMILE Trial Complications at removal Complication at removal Control N (%) Integrated dressing N (%) Infiltration 17 (11) 17 (11) Leaking 9 (6) 12 (8) Partial or complete 8 (5) 7 (5) dislodgement too painful to tolerate 8 (5) 7 (5) Occlusion 7 (5) 3 (2) Phlebitis (clinical definition) 3 (2) 1 (1)

38 SMILE Trial Promising pilot trial results Will apply to the Australian Government to fund a large multi-centre randomised controlled trial

39 What next? Securing peripheral venous catheters: Comparing primary dressings with and without additional securement products to prevent device failure (SECURe-PVC) Amanda Corley, Amanda Ullman, Nicole Marsh, Claire Rickard

40 SECURe-PVC trial Intervention group 1 Sterile tape around PIV hub Sterile tape over hub Bordered Polyurethane Dressing Non-sterile tape over PIV dressing & extension tubing or administration set

41 SECURe-PVC trial Intervention group 2: Intervention group 1 plus a tubular bandage Control Group Bordered polyurethane dressing Non-sterile tape over extension tubing/administration set

42 Any questions? Thank you for listening.