Novel Medical Device for Pharmacological Therapy

Fundacion Miguel Servet262 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

262

Conditions

Vascular Access Vascular Access Complication Vascular Access Complications Catheter Malfunction

Interventions

SECHOLD DEVICEDEVICE

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.

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

Inclusion Criteria: * patients admitted to the intensive care unit * patients with authorization to take part in the study Exclusion Criteria: * Patients with pre-existing medical conditions: Patients with diseases affecting coagulation, such as hemophilia or thrombocytopathies, could be excluded. * Active infection patients: Any patient with vascular access site infections or systemic infections may be excluded to avoid complications. * Inability to give informed consent: Patients who are unable to understand or consent to participate in the study.

Outcomes

Primary Outcomes

To reduce the risk of complications associated with the number of pharmacological errors.

Recognize the number of pharmacological errors (DRUG INTERACTION, WRONG DRUG, WRONG DOSAGE, WRONG SPEED) that have occurred

Time frame: day 1, day 7, day 14, at 6 months after placement and start of the study

To reduce complications associated with accidental catheter withdrawals.

Number of complications associated with accidental catheter withdrawals during the study period

Time frame: day 1, day 7, day 14, at 6 months after placement and start of the study

Secondary Outcomes

Reduce complications associated with venous catheter placement and maintenance (thrombosis, phlebitis, catheter obstruction).

Number of complications associated with venous catheter placement and maintenance (thrombosis, phlebitis, catheter obstruction)

Time frame: day 1, day 7, day 14, at 6 months after placement and start of the study

Novel Medical Device for Pharmacological Therapy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts