A Pilot Study of a Novel Medical Device for Pharmacological Therapy: The SecHold Device

What this Trial Is About

Researchers are evaluating a new medical device called the SECHOLD device designed to improve the safety and management of multiple intravenous therapies. This device aims to reduce complications related to intravenous therapy by better organizing and identifying the pharmacological treatments administered to patients. The study is a pilot, randomized trial conducted by a multidisciplinary team including critical care and engineering professionals to validate this new fixation device in clinical settings such as intensive care units and operating rooms. The SECHOLD device allows the simultaneous connection of 3 to 6 intravenous therapies to a single vascular access. It features labeling with drug name, concentration, and infusion range, as well as a universal color code to help reduce medication errors. The device attaches infusion systems securely to surfaces or clothing to prevent accidental dislodgement and tangling. Participants are randomly assigned to either a control group using traditional fixation methods or an intervention group using the SECHOLD device. Participants admitted to the intensive care unit will be assessed at multiple time points: day 1, day 7, day 14, and 6 months after device placement. Researchers will monitor the frequency of pharmacological errors, catheter withdrawals, and complications such as thrombosis, phlebitis, and catheter obstruction. The study also tracks device safety and effectiveness in managing vascular access. Patients will be followed for up to six months to evaluate these outcomes.

Novel Medical Device for Pharmacological Therapy