Novel Medical Device for Pharmacological Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

SECHOLD DEVICE: PLACEMENT OF A MULTIPLE THERAPY GRIPPING DEVICE TO FIX THE DRIPPER SYSTEMS ALONG ITS PATH TO SOME SURFACE OR SPACE, AVOIDING IT TO REMAIN IN THE AIR, WITHOUT MARKING OR LABELING AND FAVORING ITS ORGANIZATION. SECHOLD is a vascular access fixation device designed for critical clinical environments such as ICU and operating rooms. It allows the simultaneous connection of 3-6 parenteral therapies to the same vascular access, ensuring clear and protocolized identification of each drug by means of labels with name, concentration and infusion range, in addition to a universal color code. This reduces the risk of drug administration errors and facilitates optimal visualization of essential information. SECHOLD also organizes infusion systems connected to the same vascular access, preventing knots and pulls that can compromise catheter integrity in case of accidental infusion bag drops.

Study summary

Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient. Objectives: To validate a newly created device for the reduction of complications related to the use of intravenous therapy Methods: A multidisciplinary team composed of eight professionals specializing in the field of critical care and an engineering professional in industrial design was responsible for collecting, evaluating, and materializing the ideas and needs arising from clinical practice in a device that met the standards of the same.

Eligibility

Primary outcome measure(s)

• To reduce the risk of complications associated with the number of pharmacological errors. — day 1, day 7, day 14, at 6 months after placement and start of the study
  Recognize the number of pharmacological errors (DRUG INTERACTION, WRONG DRUG, WRONG DOSAGE, WRONG SPEED) that have occurred
• To reduce complications associated with accidental catheter withdrawals. — day 1, day 7, day 14, at 6 months after placement and start of the study
  Number of complications associated with accidental catheter withdrawals during the study period

Trial sites (1)

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