Safe-Infusion Study

Launched by INTERLINKED AB · Dec 6, 2024

Keywords

ClinConnect Summary

The Safe-Infusion Study is a clinical trial looking at a new medical device designed to make intravenous (IV) access safer for patients receiving IV therapy. Every year, many patients need IV catheters, but sometimes these can lead to problems like pain or blockage. This study aims to see if the new device can help lower these issues, called mechanical complications, compared to standard devices. They plan to include about 548 patients at two different sites.

To participate in the trial, you need to be 18 years or older and expected to receive an IV for at least two hours or in shorter sessions lasting between 15 minutes and two hours. You will need to be able to understand and speak the local language, and if you agree to join, you’ll sign a consent form. The study will monitor how well the new device works, any side effects, feedback from healthcare providers, and the overall costs related to using it. If you qualify and choose to participate, you will help researchers understand if this new device can improve the experience for future patients needing IV therapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The patient has or will get a vascular access device (VAD) expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion ≥2h and intermitted as an infusion lasting 15min to \<2h.
• • ≥18 years of age
• • Speak and understand local language
• • VADs already in place when the patient is admitted to the ward should not present with phlebitis or infiltration or occlusion
• • Participants have signed the informed consent or have a legal authorized representative (LAR) who has provided this consent
• Exclusion Criteria:
• • The VAD is expected to be used for sampling only
• • Pregnancy
• • Unable to obtain informed consent or without an available LAR to provide surrogate informed consent
• • Patients under palliative care
• • Bolus IV infusion, defined as an infusion time of \<15 min