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

Pedro Parreira, Liliana B. Sousa, Inês A. Marques, Paulo Santos-Costa, Sara Cortez, Filipa Carneiro, Arménio Cruz and Anabela Salgueiro-Oliveira
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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
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

IJERPH, 2020, vol. 17, issue 22, 1-11

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.

Keywords: usability tests; medical devices; nursing research (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2020
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