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

Area of Science:

• Medical Devices
• Nursing Practice
• Clinical Simulation

Background:

• Standard syringes pose challenges in intravenous drug administration and catheter flushing.
• A novel double-chamber syringe (DUO Syringe) has been developed to address these challenges.
• Validation of new medical devices is crucial before clinical implementation.

Purpose of the Study:

• To present a protocol for pre-clinical usability testing of the DUO Syringe prototype.
• To evaluate the effectiveness, efficiency, and safety of the DUO Syringe.
• To assess nurses' satisfaction and intention to use the DUO Syringe.

Main Methods:

• A two-step parallel randomized controlled trial was conducted in a high-fidelity simulation lab.
• Nurses performed intravenous drug administration and catheter flushing using either standard syringes or the DUO Syringe.
• Procedures were video-recorded, followed by surveys, interviews, and a focus group for qualitative assessment.

Main Results:

• Primary outcomes focus on the DUO Syringe's effectiveness, efficiency, and safety.
• Secondary outcomes assess nurses' satisfaction and intention of use.
• The protocol adheres to legal requirements and ISO norms, approved by the Ethics Committee.

Conclusions:

• The study protocol is designed for rigorous pre-clinical validation of the DUO Syringe.
• Findings will inform the potential adoption of the DUO Syringe in clinical practice.
• This research contributes to the development of improved drug delivery devices in nursing.