RecruitingNot ApplicableNCT06938750

Novel Medical Device for Pharmacological Therapy

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


Sponsor

Fundacion Miguel Servet

Enrollment

262 participants

Start Date

Jan 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 Year

Inclusion Criteria2

  • patients admitted to the intensive care unit
  • patients with authorization to take part in the study

Exclusion Criteria3

  • 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.

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Interventions

DEVICESECHOLD 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.


Locations(1)

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

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NCT06938750


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