A Randomized Trial to Investigate Safety and Effectiveness of a New Device in Reducing Mechanical Complications of Peripheral Intravenous Catheters

What this Trial Is About

Researchers are evaluating a new medical device designed to reduce mechanical complications associated with peripheral intravenous catheters (PIVCs), which are used in up to 90% of hospitalized patients. Complications such as phlebitis, infiltration, occlusion, and dislodgement can cause failure rates as high as 69%. This non-inferiority randomized clinical trial will recruit 548 patients at two sites to compare the new device's performance against current standard care. Patients in the study will be randomly assigned to either receive the investigational device added to their infusion line during IV therapy or to continue with the standard procedure without the device. The study follows standard hospital practices for PIVC infusions, with the IV therapy continuing until completion. No follow-up period is planned, and the trial is expected to last about five months. Participants will be monitored for mechanical complications during their IV therapy sessions, with data collected at baseline and immediately after catheter removal. Researchers will also evaluate adverse events, healthcare workers' opinions of the device, and the economic impact of complications on hospital resources. The primary outcome focuses on complication rates, while secondary outcomes assess safety, user feedback, and cost implications.

Safe-Infusion Study