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Study Protocol for Two-Steps Parallel Randomized Controlled Trial: Pre-Clinical Usability Tests for a New Double-Chamber Syringe

Author

Listed:
  • Pedro Parreira

    (The Health Sciences Research Unit, Nursing, Nursing School of Coimbra, 3004-011 Coimbra, Portugal)

  • Liliana B. Sousa

    (The Health Sciences Research Unit, Nursing, Nursing School of Coimbra, 3004-011 Coimbra, Portugal)

  • Inês A. Marques

    (The Health Sciences Research Unit, Nursing, Nursing School of Coimbra, 3004-011 Coimbra, Portugal
    Biophysics Institute, Coimbra Institute for Clinical and Biomedical Research (iCBR) Area of CIMAGO, Faculty of Medicine, CIBB, University of Coimbra, 3000-354 Coimbra, Portugal)

  • Paulo Santos-Costa

    (The Health Sciences Research Unit, Nursing, Nursing School of Coimbra, 3004-011 Coimbra, Portugal)

  • Sara Cortez

    (Muroplás—Plastic Engineering Industry, 4745-334 Muro, Portugal)

  • Filipa Carneiro

    (PIEP—Innovation in Polymer Engineering, Guimarães, 4800-058 Braga, Portugal)

  • Arménio Cruz

    (The Health Sciences Research Unit, Nursing, Nursing School of Coimbra, 3004-011 Coimbra, Portugal)

  • Anabela Salgueiro-Oliveira

    (The Health Sciences Research Unit, Nursing, Nursing School of Coimbra, 3004-011 Coimbra, Portugal)

Abstract

A new double-chamber syringe (DUO Syringe) was developed for intravenous drug administration and catheter flushing. This study presents a protocol for pre-clinical usability tests to validate the golden prototype of this new device, performed in a high-fidelity simulation lab by nurses. A two-steps parallel randomized controlled trial with two arms was designed (with standard syringes currently used in clinical practice and with the DUO Syringe). After randomization, eligible and consented participants will be requested to perform, individually, intravenous drug administration and flushing, following the arm that has been allocated. The procedure will be video-recorded for posterior analyses. After the completion of the tasks, nurses will be asked to answer a demographic survey, as well as an interview about their qualitative assessment of the device. A final focus group with all participants will also be conducted. Primary outcomes will concern the DUO Syringe’s effectiveness, efficiency, and safety, while secondary outcomes will focus on nurses’ satisfaction and intention of use. The pre-clinical protocol was defined according to the legal requirements and ISO norms and was reviewed and approved by the Ethics Committee of the Health Sciences Research Unit: Nursing of the Nursing School of Coimbra.

Suggested Citation

  • Pedro Parreira & Liliana B. Sousa & Inês A. Marques & Paulo Santos-Costa & Sara Cortez & Filipa Carneiro & Arménio Cruz & Anabela Salgueiro-Oliveira, 2020. "Study Protocol for Two-Steps Parallel Randomized Controlled Trial: Pre-Clinical Usability Tests for a New Double-Chamber Syringe," IJERPH, MDPI, vol. 17(22), pages 1-11, November.
    • Handle: RePEc:gam:jijerp:v:17:y:2020:i:22:p:8376-:d:444005
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    References listed on IDEAS

    as
    1. Paulo Santos-Costa & Liliana B. Sousa & Fredericus H.J. van Loon & Anabela Salgueiro-Oliveira & Pedro Parreira & Margarida Vieira & João Graveto, 2020. "Translation and Validation of the Modified A-DIVA Scale to European Portuguese: Difficult Intravenous Access Scale for Adult Patients," IJERPH, MDPI, vol. 17(20), pages 1-11, October.
    2. Sorenson, Corinna & Kanavos, Panos, 2011. "Medical technology procurement in Europe: A cross-country comparison of current practice and policy," Health Policy, Elsevier, vol. 100(1), pages 43-50, April.
    3. Kenneth F Schulz & Douglas G Altman & David Moher & for the CONSORT Group, 2010. "CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials," PLOS Medicine, Public Library of Science, vol. 7(3), pages 1-7, March.
    4. Michael Drummond & Rosanna Tarricone & Aleksandra Torbica, 2016. "Incentivizing research into the effectiveness of medical devices," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 17(9), pages 1055-1058, December.
    5. Liliana B. Sousa & Paulo Santos-Costa & Inês A. Marques & Arménio Cruz & Anabela Salgueiro-Oliveira & Pedro Parreira, 2020. "Brief Report on Double-Chamber Syringes Patents and Implications for Infusion Therapy Safety and Efficiency," IJERPH, MDPI, vol. 17(21), pages 1-8, November.
    6. Alastair Matheson, 2011. "How Industry Uses the ICMJE Guidelines to Manipulate Authorship—And How They Should Be Revised," PLOS Medicine, Public Library of Science, vol. 8(8), pages 1-5, August.
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