Castillo, Maria Isabel, Larsen, Emily, Cooke, Marie, Marsh, Nicole M., Wallis, Marianne C., Finucane, Julie, Brown, Peter, Mihala, Gabor, Carr, Peter J., Byrnes, Joshua, Walker, Rachel, Cable, Prudence, Zhang, Li, Sear, Candi, Jackson, Gavin, Rowsome, Anna, Ryan, Alison, Humphies, Julie C., Sivyer, Susan, Flanigan, Kathy, and Rickard, Claire M. (2018) Integrated versus nOn-integrated Peripheral inTravenous catheter. Which Is the most effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM study): a randomised controlled trial protocol. BMJ Open, 8. e019916.

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Abstract

Introduction Peripheral intravenous catheters (PIVCs) are frequently used in hospitals. However, PIVC complications are common, with failures leading to treatment delays, additional procedures, patient pain and discomfort, increased clinician workload and substantially increased healthcare costs. Recent evidence suggests integrated PIVC systems may be more effective than traditional non-integrated PIVC systems in reducing phlebitis, infiltration and costs and increasing functional dwell time. The study aim is to determine the efficacy, cost–utility and acceptability to patients and professionals of an integrated PIVC system compared with a non-integrated PIVC system.

Methods and analysis Two-arm, multicentre, randomised controlled superiority trial of integrated versus non-integrated PIVC systems to compare effectiveness on clinical and economic outcomes. Recruitment of 1560 patients over 2 years, with randomisation by a centralised service ensuring allocation concealment. Primary outcomes: catheter failure (composite endpoint) for reasons of: occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, localised or catheter-associated bloodstream infections. Secondary outcomes: first time insertion success, types of PIVC failure, device colonisation, insertion pain, functional dwell time, adverse events, mortality, cost–utility and consumer acceptability. One PIVC per patient will be included, with intention-to-treat analysis. Baseline group comparisons will be made for potentially clinically important confounders. The proportional hazards assumption will be checked, and Cox regression will test the effect of group, patient, device and clinical variables on failure. An as-treated analysis will assess the effect of protocol violations. Kaplan-Meier survival curves with log-rank tests will compare failure by group over time. Secondary endpoints will be compared between groups using parametric/non-parametric techniques.

Item ID:	84252
Item Type:	Article (Scholarly Work)
ISSN:	2044-6055
Copyright Information:	© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Additional Information:	This work is supported by a Becton, Dickinson and Company (BD), Researcher Initiated Clinical Research Grant Scheme. This grant has been awarded with unrestricted conditions. The Sponsor is Griffith University (Australia). Additional in-kind support is gratefully received from Griffith University, the Royal Brisbane and Women’s Hospital, Queen Elizabeth II Jubilee Hospital, and Princess Alexandra Hospital.
Date Deposited:	03 Dec 2024 03:12
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