Alekseyev S., Byrne M., Carpenter A., Franker C., Kidd C., Hulton L. Prolonging the life of a patient's IV: Sn integrative review of intravenous securement devices. Medsurg Nursing. 2012; 21:285-92

Bolton D Improving peripheral cannulation practice at an NHS Trust. British Journal of Nursing. 2010; 19:(1346)8-50

Washington, DC: Centers of Disease Control and Prevention; 2019

Frey A. M., Schears G. J. Why are we stuck on tape and suture? A review of catheter securement devices. Journal of Infusion Nursing. 2006; 29:34-8

Gorski L., Hadaway L., Hagle M. E., McGoldrick M., Orr M., Doellman D. Infusion therapy standards of practice. Journal of Infusion Nursing. 2016; 39:S1-S159

Gunther S. C., Schwebel C., Hamidfar-Roy R., Bonadona A., Lugosi M., Ara-Somohano C., Timsit J. F. Complications of intravascular catheters in ICU: Definitions, incidence and severity. A randomized controlled trial comparing usual transparent dressings versus newgeneration dressings (the ADVANCED study). Intensive Care Medicine. 2016; 42:1753-65

Helm R. E., Klausner J. D., Klemperer J. D., Flint L. M., Huang E. Accepted but unacceptable: peripheral IV catheter failure. Journal of Infusion Nursing. 2015; 38:189-203

Hertzog M. A. Considerations in determining sample size for pilot studies. Research in Nursing & Health. 2008; 31:180-91

Marsh N., Webster J., Flynn J., Mihala G., Hewer B., Fraser J., Rickard C. M. Securement methods for peripheral venous catheters to prevent failure: A randomised controlled pilot trial. Journal of Vascular Access. 2015; 16:237-44

Marsh N., Webster J., Larsen E., Cooke M., Mihala G., Rickard C. Observational study of peripheral intravenous catheter outcomes in adult hospitalized patients: A multivariable analysis of peripheral intravenous catheter failure. Journal of Hospital Medicine. 2018; 13:83-9

Miliani K., Taravella R., Thillard D., Chauvin V., Martin E., Edouard S. Peripheral venous catheter-related adverse events: Evaluation from a multicentre epidemiological study in France (the CATHEVAL Project). PLoS One. 2017; 12

Moureau N. L., Trick N., Nifong T., Perry C., Kelley C., Carrico R., Phelan D. A. Vessel health and preservation (part 1): A new evidence-based approach to vascular access selection and management. Journal of Vascular Access. 2012; 13:351-6

Canberra: Commonwealth of Australia; 2018

New K. A., Webster J., Marsh N. M., Hewer B. Intravascular device use, management, documentation and complications: A point prevalence survey. Australian Health Review. 2014; 38:345-9

Rickard C. M., Marsh N., Webster J., Playford E. G., McGrail M. R., Larsen E., Fraser J. F. Securing all intravenous devices effectively in hospitalised patients—the SAVE trial: Study protocol for a multicentre randomised controlled trial. BMJ Open. 2015; 5

Rickard C., Marsh N., Webster J., Runnegar N., Larsen E., McGrail M., Playford E. G. Dressings and securements for the prevention of peripheral intravenous catheter failure (SAVE Trial) in adults: A pragmatic, randomised, controlled, superiority trial. The Lancet. 2018; 392:419-30

Rickard C. M., McCann D., Munnings J., McGrail M. R. Routine resite of peripheral intravenous devices every 3 days did not reduce complications compared with clinically indicated resite: A randomised controlled trial. BMC Medicine. 2010; 8

Rickard C. M., Webster J., Wallis M. C., Marsh N., McGrail M. R., French V., Whitby M. Routine versus clinically indicated replacement of peripheral intravenous catheters: A randomised controlled equivalence trial. The Lancet. 2012; 380:1066-74

Russell E., Chan R. J., Marsh N., New K. A point prevalence study of cancer nursing practices for managing intravascular devices in an Australian tertiary cancer center. European Journal of Oncology Nursing. 2014; 18:231-5

Schulz K. F., Altman D. G., Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010; 7

Smith B. Peripheral intravenous catheter dwell times: A comparison of 3 securement methods for implementation of a 96-hour scheduled change protocol. Journal of Infusion Nursing. 2006; 29:14-7

Thabane L., Ma J., Chu R., Cheng J., Ismaila A., Rios L. P., Goldsmith C. H. A tutorial on pilot studies: The what, why and how. BMC Medical Research Methodology. 2010; 10

Ullman A. J., Cooke M., Rickard C. M. Examining the role of securement and dressing products to prevent central venous access device failure: A narrative review. Journal of the Association for Vascular Access. 2015; 20:99-110

Viechtbauer W., Smits L., Kotz D., Bude L., Spigt M., Serroyen J., Crutzen R. A simple formula for the calculation of sample size in pilot studies. Journal of Clinical Epidemiology. 2015; 68:1375-9

Webster J., Clarke S., Paterson D., Hutton A., van Dyk S., Gale C., Hopkins T. Routine care of peripheral intravenous catheters versus clinically indicated replacement: Randomised controlled trial. BMJ. 2008; 337

Zingg W., Pittet D. Peripheral venous catheters: An under-evaluated problem. International Journal of Antimicrobial Agents. 2009; 34:(Suppl 4)S38-42

SECUREment bundles to prevent peripheral intravenous catheter failure—the SECURE-PIVC trial: study protocol for a pilot randomized controlled trial

22 October 2020
Volume 29 · Issue 19



Peripheral intravenous catheters (PIVCs) are widely used, but failure is unacceptably common with up to 69% failing before treatment is complete. PIVC securement reduces failure, but the optimal way to achieve this is unclear. Tapes and supplementary securement products are widely used, however rigorous testing of these to reduce PIVC failure remains unexplored.

Methods and analysis

In adult medical-surgical wards at a tertiary hospital, this pilot randomized controlled trial tests standard care (bordered polyurethane dressing plus nonsterile tape over the extension tubing) against two securement interventions (intervention one: standard care plus two sterile tape strips over the PIVC hub; intervention two: intervention one plus a tubular bandage). Patients >18 years of age requiring a PIVC for >24 hours are eligible. Patients with laboratory-confirmed positive blood cultures within 24 hours of screening, known allergy to study products, current or high-risk of skin tear, or non-English speaking without interpreter are excluded. Sample size is 35 per trial arm, and central randomization is computer-generated with allocation concealed until entry. Patients and clinical staff cannot be blinded to treatment allocation. However, infection outcomes are assessed by a blinded investigator. Primary outcome is study feasibility. Secondary outcomes (PIVC failure, dwell time, skin adverse events, PIVC colonization, and cost) are compared between groups. Feasibility outcomes are reported descriptively.

Ethics and trial commencement

Ethical approvals were received from Royal Brisbane and Women's Hospital (HREC/18/QRBW/44571) and Griffith University (2018/1000). Trial commencement was May 2019.

Trial registration: ACTRN12619000026123.

Peripheral intravenous catheters (PIVCs) are required by up to 70% of hospitalized patients to deliver medical treatment (Zingg & Pittet, 2009). However, despite their importance and widespread use, rates of PIVC failure and unscheduled reinsertions due to complications are reported to be between 30% and 69% (Bolton, 2010; Gunther et al., 2016; Marsh, Webster, Larsen Cooke, Mihala, & Rickard, 2018; Rickard, McCann, Munnings, & McGrail, 2010; Rickard et al., 2012; Smith, 2006; Rickard et al., 2018). Factors responsible for early failure include phlebitis, occlusion, infiltration, extravasation, dislodgement and infection (Bolton, 2010; Marsh et al., 2018; Rickard et al., 2010; Rickard et al., 2018). PIVC failure and subsequent resite may lead to pain, anxiety and distress for patients with repeated and frequent cannulation attempts, negatively impacting their hospital stay (Helm, Klausner, Klemperer, Flint, & Huang, 2015). Furthermore, PIVC failure is costly to the healthcare institution due to the human and material resources required to replace failed PIVCs, in addition to the cost of treating PIVC complications and any sequelae (Helm et al., 2015).

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